Recent FDA 510(k) clearances
The 500 most recent 510(k) decisions, newest first.
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262526 | Safety lancet (XL)FMK · Traditional | Tianjin Huahong Technology Co., Ltd. | 09/13/2026SE |
| K261287 | Digistat CareMSX · Traditional | Ascom Ums Srl Unipersonale | 09/12/2026SE |
| K260133 | CaddieQNP · Special | Odin Medical Limited | 09/12/2026SE |
| K262874 | CraniUS PlateGWO · Special | CraniUS, LLC | 09/11/2026SE |
| K262861 | PureLift Pro MaxNFO · Special | Xtreem Pulse, LLC | 09/11/2026SE |
| K262763 | iLet Dosing Decision SoftwareQJI · Traditional | Beta Bionics, Inc. | 09/11/2026SE |
| K262397 | CuratOR EX2742GCJ · Traditional | Eizo Corporation | 09/11/2026SE |
| K262230 | Mg OSTEOREVIVE;Mg OSTEOCRETEMQV · Traditional | Bone Solutions, Inc. | 09/11/2026SE |
| K262151 | SpaceOAR Flex SystemOVB · Traditional | Boston Scientific Corporation | 09/11/2026SE |
| K262050 | Vioseal XKIF · Traditional | Spident Co., Ltd. | 09/11/2026SE |
| K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…OVD · Traditional | INNO Holdings Inc. DBA Innovasis | 09/11/2026SE |
| K262007 | PRIMED AAMI Level 3 Open Back GownsQPC · Traditional | PRIMED Medical Products, Inc. | 09/11/2026SE |
| K261837 | FINDER Flu A&B/SARS-CoV-2 TestQOF · Traditional | Baebies, Inc. | 09/11/2026SE |
| K261807 | Sequential Circulator (SC-4004-DL, SC-4008-DL)JOW · Traditional | Bio Compression Systems, Inc. | 09/11/2026SE |
| K261580 | ZBPro Diagnostic (Version 2.0)MLO · Traditional | Zbeats, Inc. | 09/11/2026SE |
| K261338 | RENASYS DYNAFLOW Kit (66807741)OMP · Traditional | Smith & Nephew Medical, Ltd. | 09/11/2026SE |
| K261305 | Micsi-PetKPS · Traditional | Microstructure Imaging, Inc. | 09/11/2026SE |
| K261255 | Kowa FM-600MYC · Traditional | Kowa Company, Ltd. Chofu Factory | 09/11/2026SE |
| K261019 | AnterionOBO · Traditional | Heidelberg Engineering GmbH | 09/11/2026SE |
| K260410 | Single Use Ureteral Access SheathFED · Special | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 09/11/2026SE |
| K260115 | DRIM-Nail System · Traditional | 41Medical AG | 09/11/2026SE |
| K260063 | GSPE SpacerJWH · Traditional | The General Hospital Corporation, d/b/a… | 09/11/2026SE |
| K260001 | Mint ACE PumpQFG · Traditional | Beta Bionics, Inc. | 09/11/2026SE |
| K254185 | Potenza PrimeGEI · Traditional | Jeisys Medical Incorporated | 09/11/2026SE |
| K254177 | Disposable Sterile Skull Drill (LZ)HBF · Traditional | Guizhou Zirui Technology Co., Ltd. | 09/11/2026SE |
| K254174 | Surgical Power SystemHBC · Traditional | Guizhou Zirui Technology Co., Ltd. | 09/11/2026SE |
| K254123 | Ecomed Disposable Administration SetsFPA · Abbreviated | Ecomed Solutions, LLC | 09/11/2026SE |
| K254119 | Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…MWJ · Traditional | Shenzhen Xinyan Medical Technology Co.,ltd. | 09/11/2026SE |
| K254072 | BoneVueKGI · Traditional | Curvebeam AI / Curvebeam, LLC | 09/11/2026SE |
| K254051 | Extroducer Infusion Catheter SystemKRA · Traditional | SmartWise Sweden AB | 09/11/2026SE |
| K254041 | SkinSmart Antimicrobial HydroGelFRO · Traditional | Magic Science Supply, LLC | 09/11/2026SE |
| K253063 | Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series)…BTO · Special | Vitaltec Corporation | 09/11/2026SE |
| K262426 | Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)GEX · Traditional | Wuhan Pioon Technology Co., Ltd. | 09/10/2026SE |
| K262293 | EVOLUTION MPX Total Knee SystemJWH · Traditional | Suzhou Microport Orthorecon Co., Ltd. | 09/10/2026SE |
| K262202 | Cerasmart ForteEBF · Traditional | GC America, Inc. | 09/10/2026SE |
| K262079 | 4K Camera Head OLYMPUS CH-S700-08-LBFET · Traditional | Olympus Medical Systems Corp. | 09/10/2026SE |
| K261929 | Upper Arm Blood pressure monitor (BP7155D)DXN · Special | OMRON Healthcare, Inc. | 09/10/2026SE |
| K261795 | Quicktome Software SuiteQIH · Traditional | Omniscient Neurotechnology Pty, Ltd. | 09/10/2026SE |
| K261696 | ACUNAV Luxera 4D ICE CatheterOBJ · Special | Siemens Medical Solutions USA, Inc. | 09/10/2026SE |
| K261562 | Diode Laser Therapy SystemGEX · Traditional | Sanhe LEFIS Electronics Co., Ltd. | 09/10/2026SE |
| K261409 | BioTeke® Multi-Drug Urine Test CupNFT · Traditional | Bioteke Corporation (Wuxi) Co., Ltd. | 09/10/2026SE |
| K260879 | 4DMQIH · Traditional | Invia, LLC | 09/10/2026SE |
| K260110 | danumed Extension Set for Gastrostomy ButtonPIF · Traditional | Danumed Medizintechnik GmbH | 09/10/2026SE |
| K254246 | LT Antibacterial Foam with Silver DressingNAD · Traditional | Zhejiang Longterm Medical Technology Co., Ltd. | 09/10/2026SE |
| K254111 | Irrigation/Urology SetsLJH · Traditional | B.Braun Medical, Inc. | 09/10/2026SE |
| K254074 | TruPressDRS · Traditional | Procerus Enterprises | 09/10/2026SE |
| K254009 | Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)SJH · Traditional | Lakong Medical Devices Co., Ltd. | 09/10/2026SE |
| K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot)HAW · Traditional | Koh Young Technology, Inc. | 09/10/2026SE |
| K262542 | Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder…LZA · Special | Top Glove Sdn. Bhd. | 09/09/2026SE |
| K262488 | Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9…FGB · Traditional | Guangzhou Red Pine Medical Instrument Co., Ltd. | 09/09/2026SE |
| K261793 | Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and…LZA · Traditional | Maxter Healthcare, Inc. | 09/09/2026SE |
| K261470 | PurGuard360(QF10)NHV · Traditional | E.A.M Benelux B.V | 09/09/2026SE |
| K260997 | Sis Blu (SISBLU-30-01);SIS Blu (SISBLU-15-01)PLL · Traditional | Endoclot Plus Co., Ltd. | 09/09/2026SE |
| K260652 | ColActive PlusKGN · Traditional | Covalon Technologies, Ltd. | 09/09/2026SE |
| K252486 | ChestView US (1.1)MYN · Traditional | Gleamer | 09/09/2026SE |
| K251417 | ReVISION 2QIH · Traditional | Argus Cognitive, Inc. | 09/09/2026SE |
| K262341 | b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and…JWH · Traditional | B-One Ortho, Corp. | 09/08/2026SE |
| K262173 | N22 Offset Humeral HeadKWT · Traditional | Shoulder Innovations, Inc. | 09/08/2026SE |
| K261987 | Reusable SmartPegEKX · Traditional | Osstell AB | 09/08/2026SE |
| K261956 | Dental Barriers and Sleeves (AB0006)PEM · Traditional | ANI Co., Ltd. | 09/08/2026SE |
| K261823 | da Vinci Surgical System, Model IS5000NAY · Traditional | Intuitive Surgical, Inc. | 09/08/2026SE |
| K261715 | Emboliner Embolic Protection System (EPC-03)PUM · Traditional | Emboline, Inc. | 09/08/2026SE |
| K261462 | LANDMARK Total Knee SystemMBH · Traditional | Smith & Nephew, Inc. | 09/08/2026SE |
| K260312 | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs…LZA · Special | Gmp Medicare Sdn. Bhd. | 09/08/2026SE |
| K260229 | Electric wheelchair (HC819N, HC830N, HC831N)ITI · Traditional | Yongkang Hengyi Vehicle Co., Ltd. | 09/08/2026SE |
| K260227 | EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS…KPR · Traditional | DRTECH Corporation | 09/08/2026SE |
| K260062 | MODI SystemQRX · Traditional | DreaMed Diabetes, Ltd. | 09/08/2026SE |
| K260053 | Power Wheelchair (OS-R-M01I)ITI · Traditional | Beijing OrionStar Technology Co., Ltd. | 09/08/2026SE |
| K254294 | Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A…HIH · Traditional | Zhejiang Geyi Medical Instrument Co., Ltd. | 09/08/2026SE |
| K253988 | LiteSet TraysKCT · Traditional | Nobel Biocare AB | 09/08/2026SE |
| K261131 | Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J…NUH · Traditional | Shenzhen Osto Medical Technology Co.,Ltd | 09/06/2026SE |
| K260396 | KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)OBP · Traditional | Fidelity BioPharma Co. | 09/06/2026SE |
| K261684 | FreezeSpray TAMLY · Traditional | Cryosurgery, Inc. | 09/05/2026SE |
| K254135 | LipoSurg ARTISTQPB · Traditional | Nouvag AG | 09/05/2026SE |
| K262828 | KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special | S.M.A.I.O | 09/04/2026SE |
| K262292 | Gastric AlimetryMYE · Traditional | Alimetry , Ltd. | 09/04/2026SE |
| K262277 | 70 NeuGlide CatheterQJP · Special | Piraeus Medical, Inc. | 09/04/2026SE |
| K262235 | ApexCut Blade with Automated EM Tracking (187BL4012EM);ApexCut Blade with Automated…PGW · Traditional | Medtronic Xomed, Inc. | 09/04/2026SE |
| K262130 | ATTUNE Revision Knee SystemJWH · Traditional | Depuy Orthopaedics, Inc. | 09/04/2026SE |
| K262060 | 3D-RD-SLLZ · Traditional | Radiopharmaceutical Imaging & Dosimetry, LLC | 09/04/2026SE |
| K261935 | Surgical and Prosthetic TraysKCT · Traditional | Dentsply Sirona, Inc. | 09/04/2026SE |
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260756 | TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)EZL · Traditional | Sentinel Medical Technologies, | 09/04/2026SE |
| K260525 | NextMR SpineQIH · Traditional | MRI2CT, Inc. | 09/04/2026SE |
| K260331 | IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)DHB · Traditional | Siemens Healthcare Diagnostics Products, Ltd. | 09/04/2026SE |
| K260035 | Digital Indeflator INFLANTEMAV · Traditional | UAB Telemedicina | 09/04/2026SE |
| K254264 | Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIAQVF · Dual Track | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | 09/04/2026SE |
| K254262 | Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIAPSZ · Dual Track | Ortho Clinical Diagnostics Inc. (QuidelOrtho) | 09/04/2026SE |
| K253909 | NeoPEX Pre-Mixed Obturation PasteKIF · Traditional | NuSmile, Ltd. | 09/04/2026SE |
| K253836 | FCT iStream Phase 2JAK · Traditional | Fujifilm Corporation | 09/04/2026SE |
| K253529 | Peerbridge COR MDx (Cor MDx)MWJ · Abbreviated | Peerbridge Health, Inc. | 09/04/2026SE |
| K262769 | Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)MTJ · Special | Orthocon, Inc. | 09/03/2026SE |
| K262460 | Rezum SystemKNS · Traditional | Boston Scientific | 09/03/2026SE |
| K262315 | NeuroBlate SystemONO · Traditional | Monteris Medical | 09/03/2026SE |
| K262243 | Profisil FreeLBH · Traditional | Kettenbach GmbH & Co. KG | 09/03/2026SE |
| K261800 | Helo Max Thrombectomy System (HEL2090)QEW · Traditional | Endovascular Engineering | 09/03/2026SE |
| K261647 | Tempo Plating System; Ultra Compression Screw SystemHRS · Traditional | Pace Surgical | 09/03/2026SE |
| K261622 | Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52…HGX · Traditional | Philips Consumer Lifestyle B.V. | 09/03/2026SE |
| K261281 | CROSSLEAD Standard 035 and CROSSLEAD Stiff 035DQX · Traditional | Filmecc Co., Ltd. | 09/03/2026SE |
| K260503 | Triton 1 SystemFDF · Traditional | Neptune Medical, Inc. | 09/03/2026SE |
| K254035 | Mayumi Thrombectomy SystemQEZ · Traditional | MicroVention, Inc., d/b/a Terumo Neuro | 09/03/2026SE |
| K254000 | Happy Health Blood Pressure MonitorDXN · Traditional | Happy Health, Inc. | 09/03/2026SE |
| K253989 | HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based…NUC · Traditional | Maxigen Biotech, Inc. | 09/03/2026SE |
| K253673 | Mcare System (MW-20)LQK · Traditional | Marani Health, Inc. | 09/03/2026SE |
| K251794 | Tenax® Laser Resistant Endotracheal TubeBTR · Traditional | Bryan Medical, Inc. | 09/03/2026SE |
| K262809 | ArthroTAK Tendon Anchor KitMBI · Special | ArthroTAK, LLC | 09/02/2026SE |
| K262420 | Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)GEH · Traditional | Serpex Medical | 09/02/2026SE |
| K262364 | Ellian Enigma RF DeviceGEI · Traditional | Ellian Corp | 09/02/2026SE |
| K262153 | Pivot Insulin Delivery SystemLZG · Traditional | Modular Medical, Inc. | 09/02/2026SE |
| K261749 | Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs… · Traditional | Cardinalhealth | 09/02/2026SE |
| K261589 | 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)GEX · Traditional | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 09/02/2026SE |
| K261313 | Vivid Explorer/Vivid Advanced/Vivid FocusIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 09/02/2026SE |
| K261311 | HyalomatrixQSZ · Traditional | Anika Therapeutics, Inc. | 09/02/2026SE |
| K260432 | Ruby Intravascular CatheterFOZ · Traditional | Venocare, Inc. | 09/02/2026SE |
| K254198 | Trexo TheoPHL · Traditional | Trexo Robotics, Inc. | 09/02/2026SE |
| K254090 | I-View®MUE · Traditional | Hologic, Inc. | 09/02/2026SE |
| K254026 | 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video…EOQ · Traditional | Flexicare Medical Limited. | 09/02/2026SE |
| K253948 | Momentum Acetabular Cup SystemLZO · Traditional | United Orthopedic Corporation | 09/02/2026SE |
| K253065 | Aevumed SUPERCYNCH Button SystemMBI · Traditional | Aevumed, Inc. | 09/02/2026SE |
| K262783 | RadiForce MX247WPGY · Abbreviated | Eizo Corporation | 09/01/2026SE |
| K262774 | Wearable breast pump (Model: XN/MD-2249BS, ZFHF)HGX · Traditional | Guangdong Horigen Mother & Baby Products Co., Ltd. | 09/01/2026SE |
| K262451 | Arthrex DynaNite StaplesJDR · Traditional | Arthrex, Inc. | 09/01/2026SE |
| K262269 | CO2 Laser System (MBT- CO2 Laser)GEX · Traditional | Beijing Mega Beauty Technology Co., Ltd. | 09/01/2026SE |
| K261811 | PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested…QSO · Traditional | PRIMED Medical Products, Inc. | 09/01/2026SE |
| K260884 | UNIDRIVE Select SystemGCJ · Traditional | Karl Storz SE & CO. KG | 09/01/2026SE |
| K260758 | MAGNETOM Free.Max; MAGNETOM Free.StarLNH · Traditional | Siemens Shenzhen Magnetic Resonance , Ltd. | 09/01/2026SE |
| K260656 | Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP…MHX · Traditional | GE Healthcare Finland Oy | 09/01/2026SE |
| K260613 | AMI Plasma Cartridge, AMIJID · Traditional | Sequitur Health Corp. | 09/01/2026SE |
| K253961 | SK Knee SystemJWH · Traditional | Just Medical Devices (Tianjin) Co., Ltd. | 09/01/2026SE |
| K262788 | Nova HD+SGT · Special | Aura Wellness, LLC | 08/31/2026SE |
| K262747 | ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0OCC · Special | Abbott Diagnostics Scarborough, Inc. | 08/31/2026SE |
| K262658 | Automatic Digital Blood Pressure monitor (LD-526)DXN · Special | Honsun (Nantong) Co., Ltd. | 08/31/2026SE |
| K261718 | EZFluence (RADEZ V2)IYE · Traditional | Radformation, Inc. | 08/31/2026SE |
| K261695 | Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)EBF · Traditional | Guilin Kevin Peter Technology Co., Ltd. | 08/31/2026SE |
| K261403 | Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A…FPB · Traditional | Global Life Sciences Solutions USA, LLC | 08/31/2026SE |
| K260767 | Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…OHS · Traditional | Kam Yuen Plastic Products , Ltd. | 08/31/2026SE |
| K260488 | MULTIX Impact; MULTIX Impact CKPR · Traditional | Siemens Medical Solutions USA, Inc. | 08/31/2026SE |
| K260387 | SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)NFO · Traditional | Hironic Co., Ltd. | 08/31/2026SE |
| K254217 | AerloomJOW · Traditional | Evolym, LLC | 08/31/2026SE |
| K262735 | LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)MXD · Special | Medtronic, Inc. | 08/28/2026SE |
| K262722 | Primal K-Wire (P99-193-1410)HTY · Special | Paragon 28, Inc. | 08/28/2026SE |
| K262013 | Kiba CTO Crossing CatheterPDU · Special | Reflow Medical, Inc. | 08/28/2026SE |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…HRS · Traditional | Ortler Global Tibbi Gerecler Anonim Sirketi | 08/28/2026SE |
| K261582 | Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)NUV · Traditional | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 08/28/2026SE |
| K261378 | Rayvolve AZchestQBS · Traditional | AZmed | 08/28/2026SE |
| K261176 | Zoom 4S CatheterQJP · Traditional | Imperative Care, Inc. | 08/28/2026SE |
| K260617 | Tigertriever 13 Ultra Revascularization DeviceNRY · Traditional | Rapid Medical Ltd. | 08/28/2026SE |
| K260517 | Automatic Core Biopsy InstrumentKNW · Traditional | Zhejiang Curaway Medical Technology Co., Ltd. | 08/28/2026SE |
| K260343 | Carescape Canvas 1000; Carescape Canvas Smart DisplayMHX · Traditional | GE Healthcare Finland Oy | 08/28/2026SE |
| K260203 | Fule Vertebroplasty Balloon CatheterHRX · Traditional | Beijing Fule Science & Technology Development… | 08/28/2026SE |
| K260047 | cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas…PGX · Traditional | Roche Molecular Systems, Inc. | 08/28/2026SE |
| K260045 | cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas®…OZN · Traditional | Roche Molecular Systems, Inc. | 08/28/2026SE |
| K254261 | Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)MQL · Traditional | Cell Store (Beijing) Biotechnology Co., Ltd. | 08/28/2026SE |
| K253954 | X-Guide Surgical Navigation SystemQRY · Traditional | X-Nav Technologies, LLC | 08/28/2026SE |
| K253630 | Mpact 3D Metal FoamLPH · Traditional | Medacta International S.A. | 08/28/2026SE |
| K262744 | GenesisX RMNDXX · Special | Stereotaxis, Inc. | 08/27/2026SE |
| K262677 | Iconix Knotless TMBI · Special | Riverpoint Medical | 08/27/2026SE |
| K262654 | Dexus Prosthetic System (MSL2, MSR2)GXY · Special | Zhejiang Qiangnao Technology Co.,Ltd | 08/27/2026SE |
| K262268 | Optiflow Oxygen Kit (AA484J)BTT · Special | Fisher and Paykel Healthcare Limited | 08/27/2026SE |
| K262104 | Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)LRK · Special | Ram.Shaw Pte., Ltd. | 08/27/2026SE |
| K261821 | 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)GEX · Traditional | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 08/27/2026SE |
| K261802 | Glidewell Denture Base ResinEBI · Traditional | Prismatik Dentalcraft, Inc. | 08/27/2026SE |
| K261360 | EasyCare Tx 2MOD · Traditional | Resmed Corp | 08/27/2026SE |
| K260870 | Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)MLY · Traditional | Gebauer Company | 08/27/2026SE |
| K260856 | Disposable Distal Attachment D-201-13404FDS · Traditional | Olympus Medical Systems Corporation | 08/27/2026SE |
| K260824 | Gastrointestinal Videoscope Olympus GIF-2T1500FDS · Traditional | Olympus Medical Systems Corporation | 08/27/2026SE |
| K260751 | 35 Helix GuidewireMOF · Traditional | Piraeus Medical, Inc. | 08/27/2026SE |
| K260711 | Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…KGN · Traditional | Berkeley Advanced Biomaterials | 08/27/2026SE |
| K260545 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…NBW · Traditional | Ascensia Diabetes Care | 08/27/2026SE |
| K260481 | GC85AKPR · Traditional | Samsung Electronics Co., Ltd. | 08/27/2026SE |
| K260401 | Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)PSV · Traditional | Olympus Medical Systems Corporation | 08/27/2026SE |
| K253859 | Scarlet Pro (Scarlet Pro)GEI · Traditional | VIOL Co., Ltd. | 08/27/2026SE |
| K262595 | VariLift-C Cervical Interbody Fusion SystemODP · Special | Wenzel Spine, Inc. | 08/26/2026SE |
| K262581 | GraftGun Universal Graft Delivery System (GDS®)FMF · Special | SurGenTec, LLC | 08/26/2026SE |
| K261394 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus…DXN · Traditional | JOYTECH Healthcare Co., Ltd. | 08/26/2026SE |
| K261153 | LithoVue Elite Digital Flexible Ureteroscope SystemFGB · Traditional | Boston Scientific Corporation | 08/26/2026SE |
| K261142 | Ponto 5 Mini; Ponto 5 SuperpowerMAH · Special | Oticon Medical AB | 08/26/2026SE |
| K260972 | OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorGCJ · Traditional | Sony Corporation | 08/26/2026SE |
| K260811 | Heartvue.ProtonQIH · Traditional | Heartvue.ai, Inc. | 08/26/2026SE |
| K260733 | MRIA Radiation Therapy Information System (MRIA)IYE · Traditional | Manteia Technologies Co., Ltd. | 08/26/2026SE |
| K260407 | Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns…FYA · Traditional | Principle & Will Co., Ltd. | 08/26/2026SE |
| K254103 | HOPKINS Telescopes for ArthroscopyHRX · Traditional | Karl Storz SE & CO. KG | 08/26/2026SE |
| K253877 | StimTrial Neuromodulation SystemGZF · Special | Bioventus, LLC | 08/26/2026SE |
| K253715 | Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…PIF · Traditional | Maquet Critical Care AB | 08/26/2026SE |
| K262631 | Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)QRK · Special | SteriLance Medical (Suzhou), Inc. | 08/25/2026SE |
| K261747 | Report StudioOLV · Traditional | Beacon Biosignals, Inc. | 08/25/2026SE |
| K261719 | Promisemed X-Safety Pen NeedleFMI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 08/25/2026SE |
| K261595 | Ceevra Reveal 4QIH · Traditional | Ceevra, Inc. | 08/25/2026SE |
| K261514 | Calcium Hydroxide Temporary Filling Material (KP-Cal)KIF · Traditional | Guilin Kevin Peter Technology Co., Ltd. | 08/25/2026SE |
| K254304 | iNOS intraoral biosensorPLC · Traditional | Achaemenid, LLC | 08/25/2026SE |
| K253879 | Monofix PdoNEW · Traditional | Samyang Holdings Corporation | 08/25/2026SE |
| K252535 | Inno-Switch Laparoscopic InstrumentsGEI · Traditional | Taiwan Surgical Corporation | 08/25/2026SE |
| K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle TrayFMF · Traditional | Sol-Millennium Medical, Inc. | 08/25/2026SE |
| K261381 | TiLink-L SI Joint Fusion SystemOUR · Traditional | SurGenTec, LLC | 08/24/2026SE |
| K260604 | BiWaze Clear SystemNHJ · Traditional | Abmrc, LLC | 08/24/2026SE |
| K260246 | SEISMIQ Intravascular Lithotripsy SystemPPN · Traditional | Bolt Medical, Inc. | 08/24/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K254286 | Guided Bone Regeneration SystemDZL · Traditional | DentalMaster(Xiamen)Medical Technology Co., Ltd. | 08/24/2026SE |
| K254027 | Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…IYN · Traditional | Sonoscape Medical Corp. | 08/24/2026SE |
| K253515 | Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and AugmentsJDI · Traditional | Biomet Orthopedics, Inc. | 08/24/2026SE |
| K260691 | BTL-699OBP · Traditional | BTL Industries, Inc. | 08/23/2026SE |
| K253910 | Stitch - Suture Wires and TapesGAT · Traditional | GM Dos Reis Industria e Comercio Ltda. | 08/22/2026SE |
| K262538 | Artix MT;Artix Thin-Walled SheathQEW · Special | Inari Medical, Inc. | 08/21/2026SE |
| K262127 | DS Core CBCT AnatomyQIH · Traditional | Dentsply Sirona | 08/21/2026SE |
| K262089 | Disposable Warming BlanketDWJ · Traditional | Hangzhou Tappa Medical Technology Co., Ltd. | 08/21/2026SE |
| K262074 | Any-ZircosEIH · Traditional | Mediclus Co., Ltd. | 08/21/2026SE |
| K262005 | Affera Integrated Mapping SystemDQK · Special | Medtronic, Inc. | 08/21/2026SE |
| K261882 | Pisces-SC Standalone Cervical Interbody SystemOVE · Traditional | Osseus Fusions Systems, LLC | 08/21/2026SE |
| K261710 | AYON Power Liposuction Cannulas and AYON Power Liposuction Cannula AdaptorsQPB · Traditional | Apyx Medical Corporation | 08/21/2026SE |
| K261466 | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBMMOB · Traditional | Zeus Scientific | 08/21/2026SE |
| K261354 | Electric wheelchair (D03)ITI · Traditional | Foshan Sowell Medical Technology Co., Ltd. | 08/21/2026SE |
| K261015 | Solo Scope Colonoscope SystemFDF · Traditional | Gi View, Ltd. | 08/21/2026SE |
| K260643 | Cimilre Dual MaxHGX · Traditional | Cimilre Co., Ltd. | 08/21/2026SE |
| K260584 | BoneMRIQIH · Traditional | Mriguidance B.V. | 08/21/2026SE |
| K253817 | IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaLLL · Traditional | Immunodiagnostics Systems Limited | 08/21/2026SE |
| K253728 | EVOLUTION® AM BIOFOAM® Tibial SystemMBH · Traditional | Microport Orthopedics, Inc. | 08/21/2026SE |
| K253726 | uAngio AVIVA CXOWB · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 08/21/2026SE |
| K253699 | Tempus ECG-PHSAT · Traditional | Tempus AI, Inc. | 08/21/2026SE |
| K253692 | AVVIGO+ Multi-Modality Guidance SystemDQK · Traditional | Boston Scientific | 08/21/2026SE |
| K262515 | Kneu Platform (V2)GYD · Traditional | Kneu Health Digital , Ltd. | 08/20/2026SE |
| K262506 | Remex Spine Surgery Navigation - Universal InstrumentsOLO · Special | Remex Medical Corp. | 08/20/2026SE |
| K262113 | HardyDisk AST Tebipenem 10µg (TBP10)JTN · Traditional | Hardy Diagnostics | 08/20/2026SE |
| K261298 | Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))HGX · Traditional | Guangdong Youmeng Electrical Technology Co., Ltd. | 08/20/2026SE |
| K261049 | Scala® TLMAX · Traditional | Spineart SA | 08/20/2026SE |
| K260817 | MIRA Surgical SystemSAB · Traditional | Virtual Incision | 08/20/2026SE |
| K260579 | Infinity® Acute Care System (IACS) VG8.1MHX · Traditional | Draeger Medical Systems, Inc. | 08/20/2026SE |
| K260242 | CPETWise PlatformBTY · Traditional | Medibyt , Ltd. | 08/20/2026SE |
| K253807 | Valence InVent Xtend (CVG-4101-VXA)MOD · Traditional | Convergence Medical Sciences , Ltd. | 08/20/2026SE |
| K262622 | Swoop® Portable MR Imaging® SystemLNH · Special | Hyperfine, Inc. | 08/19/2026SE |
| K262537 | Versalock Sterile Plating SystemHRS · Special | GM Dos Reis Industria e Comercio Ltda. | 08/19/2026SE |
| K262070 | Diode Laser Therapy Systems (DL612A)GEX · Traditional | Hebei Zollvan Medical Technology Co., Ltd. | 08/19/2026SE |
| K261964 | Echolaser X4GEX · Traditional | Elesta S.P.A | 08/19/2026SE |
| K261686 | Elecsys Phospho-Tau (217P) PlasmaSET · Traditional | Roche Diagnostics | 08/19/2026SE |
| K261413 | Extron 3;EXTRON 6OWB · Traditional | DRTECH Corporation | 08/19/2026SE |
| K261083 | Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum…MQG · Traditional | CooperSurgical, Inc. | 08/19/2026SE |
| K260799 | Nipro Dry Acid Concentrate MixerKPO · Traditional | Nipro Technical Solutions, Incoporated | 08/19/2026SE |
| K260463 | ZEROS Dental Implant SystemDZE · Special | Zeros Co., Ltd. | 08/19/2026SE |
| K260209 | ENDOFLATOR+; Smart Smoke EvacuationHIF · Traditional | Karl Storz SE & CO. KG | 08/19/2026SE |
| K254213 | Pascall Sensor Unit (PSU1)OLT · Special | Pascall Systems, Inc. | 08/19/2026SE |
| K253431 | Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN…LXB · Traditional | Shokz Health Global Limited | 08/19/2026SE |
| K253240 | PrecivityAD2 TestSET · Traditional | C2N Diagnostics, LLC | 08/19/2026SE |
| K262729 | TeKBrace Solo Soft Tissue Reinforcement DeviceQUW · Special | Theramicro | 08/18/2026SE |
| K262489 | BluEX Cervical Expandable Cage SystemODP · Special | L&K BIOMED Co., Ltd. | 08/18/2026SE |
| K262479 | TearCare SystemORZ · Special | Sight Sciences, Inc. | 08/18/2026SE |
| K262135 | Lancing deviceQRL · Traditional | Tianjin Huahong Technology Co., Ltd. | 08/18/2026SE |
| K261641 | Lower Limb AI (LLAI)QIH · Traditional | AI Planning Logic, Inc. | 08/18/2026SE |
| K260984 | HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)HIH · Traditional | Axora Medical, Inc. | 08/18/2026SE |
| K260794 | NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT…LZA · Traditional | Kossan International Sdn Bhd | 08/18/2026SE |
| K260266 | Tympendi (810)KHJ · Traditional | Grace Medical, Inc. | 08/18/2026SE |
| K254256 | LUOFUCON® Wound MatrixQSZ · Traditional | Huizhou Foryou Medical Devices Co., Ltd. | 08/18/2026SE |
| K254071 | p17 XR MicrocatheterQJP · Traditional | Wallaby Medical | 08/18/2026SE |
| K261500 | KBA3D (v2.4.0)LLZ · Traditional | S.M.A.I.O | 08/17/2026SE |
| K260224 | MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)DSB · Traditional | ImpediMed Limited | 08/17/2026SE |
| K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…JEY · Traditional | KLS-Martin L.P. | 08/17/2026SE |
| K254250 | MagicScan-1.5, GreenMR Serenity 1.5TLNH · Traditional | Xingaoyi Medical Equipment Co.,Ltd | 08/17/2026SE |
| K260563 | CN-SuiteOLX · Traditional | FIND Surgical Sciences Inc. D/B/A FIND Neuro | 08/16/2026SE |
| K262639 | BAGUERA® C Cervical Disc Surgical InstrumentsQLQ · Traditional | Spineart SA | 08/14/2026SE |
| K262571 | EnCor EnCompass Breast Biopsy and Tissue Removal SystemKNW · Special | Bard Peripheral Vascular, Inc. | 08/14/2026SE |
| K262552 | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)FGB · Special | Scivita Medical Technology Co., Ltd. | 08/14/2026SE |
| K262452 | AutoContour (RADAC V6)QKB · Special | Radformation, Inc. | 08/14/2026SE |
| K262449 | AdvaViewLLZ · Special | Advahealth Solutions, LLC | 08/14/2026SE |
| K262424 | Willow 12 GuidewireMOF · Special | Arbor Endovascular, LLC | 08/14/2026SE |
| K262419 | Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe…HCG · Special | Cerenovus, Inc. | 08/14/2026SE |
| K261890 | 52Fr ViSiGi LUX; 52Fr ViSiGi 3D®KNT · Special | Boehringer Laboratories, LLC | 08/14/2026SE |
| K261646 | Redermax® Antibacterial Wound MatrixFRO · Traditional | Beijing Kreate Medical Co., Ltd. | 08/14/2026SE |
| K261428 | NC Euphora Rapid Exchange Balloon Dilatation CatheterLOX · Traditional | Medtronic Ireland | 08/14/2026SE |
| K261228 | QuickVision Ultimate rTMSOBP · Traditional | Brain Ultimate, Inc. | 08/14/2026SE |
| K260898 | Transpara (2.1.0)QDQ · Special | Screenpoint Medical B.V. | 08/14/2026SE |
| K260559 | NHanceITDQY · Traditional | IMDS Operation B.V. | 08/14/2026SE |
| K260438 | Vital Signs Monitor (CLEO2)MWI · Traditional | Infinium Medical, Inc. | 08/14/2026SE |
| K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…GYD · Traditional | Empatica S.r.l. | 08/14/2026SE |
| K260171 | Portable Oxygen Concentrator (PO1 5B, PO1 6B)CAW · Traditional | BMC Medical Co., Ltd. | 08/14/2026SE |
| K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03)FMF · Traditional | Jiangsu Enjosim Medical Technology Co., Ltd. | 08/14/2026SE |
| K253562 | medilogFDMWJ · Traditional | Schiller AG | 08/14/2026SE |
| K262398 | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setNRY · Special | CERENOVUS, Inc. | 08/13/2026SE |
| K261626 | UltraPrint Flexible Denture UVEBI · Traditional | Guangzhou Heygears IMC., Inc. | 08/13/2026SE |
| K261499 | TrachFlushBSK · Traditional | Aw Technologies Aps | 08/13/2026SE |
| K261139 | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)GCJ · Traditional | Freyja Healthcare, LLC | 08/13/2026SE |
| K261061 | BP Go (BPP-855)DXN · Traditional | Wellvii, Inc. | 08/13/2026SE |
| K260907 | BIS Advance pEEG ModuleOLW · Traditional | Covidien LP | 08/13/2026SE |
| K260413 | Levo Gen 2 Tinnitus Therapy SystemKLW · Traditional | Levo Medical Corporation | 08/13/2026SE |
| K260277 | Mikron Trauma Bone Plate& Screw SystemHRS · Traditional | Mikron Makina San. ve Tic. Ltd. Sti. | 08/13/2026SE |
| K260211 | Dashboard (P007000)MSX · Traditional | Hill-Rom, Inc. | 08/13/2026SE |
| K254201 | Any-CemEMA · Traditional | Mediclus Co., Ltd. | 08/13/2026SE |
| K253808 | AIR Recon DLLNH · Traditional | GE Medical Systems | 08/13/2026SE |
| K253795 | MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionLPN · Traditional | Menicon Co, Ltd. | 08/13/2026SE |
| K253790 | High Intensity Focused Electromagnetic Stimulation Device (FE60)NGX · Traditional | Beijing Winkonlaser Technology Limited | 08/13/2026SE |
| K253425 | Arm-type Fully Automatic Digital Blood Pressure Monitor…DXN · Traditional | Joytech Healthcare Co. , Ltd. | 08/13/2026SE |
| K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)KNW · Special | Hologic, Inc. | 08/12/2026SE |
| K262406 | EluPro Antibiotic-Eluting BioEnvelopeFTM · Special | Boston Scientific | 08/12/2026SE |
| K262399 | Millipede SystemNRY · Special | Perfuze, Ltd. | 08/12/2026SE |
| K262392 | APRO 35 Swift CatheterDQY · Special | Alembic, LLC | 08/12/2026SE |
| K262391 | APRO 35 Swift Catheter and Alembic Aspiration TubingNRY · Special | Alembic, LLC | 08/12/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K261916 | NeuroQuant PETLLZ · Traditional | Cortechs Labs, Inc. | 08/12/2026SE |
| K261170 | BA-004CCITX · Traditional | Fujifilm Corporation | 08/12/2026SE |
| K260944 | ManaCold Compression SystemIRP · Traditional | Manamed, LLC | 08/12/2026SE |
| K260086 | CadAI-B DxQDQ · Traditional | BeamWorks, Inc. | 08/12/2026SE |
| K253846 | Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe)…OAB · Traditional | Hangzhou Ruidi Biotechnology , Ltd. | 08/12/2026SE |
| K253417 | Masimo Root Monitoring SystemMWI · Traditional | Masimo Corporation | 08/12/2026SE |
| K251641 | GF-310R Multigas Unit (GF-310R)CCK · Traditional | Nihon Kohden Corporation | 08/12/2026SE |
| K262472 | Stelo Glucose Biosensor SystemSBH · Special | Dexcom, Inc. | 08/11/2026SE |
| K261841 | Q Switched Nd:YAG Laser machine (QLQW-01)GEX · Traditional | Beijing Nubway S&T Co., Ltd. | 08/11/2026SE |
| K261398 | Dexter L6 SystemSDD · Traditional | Distalmotion SA | 08/11/2026SE |
| K261115 | VR® Personal Protective Level 4 Gown (VR Gowns)QPC · Traditional | PolyConversions, Inc. | 08/11/2026SE |
| K253985 | INNOVANCE® D-Dimer 2.0 (SMN 10873803)DAP · Traditional | Siemens Healthcare Diagnostic Products GmbH | 08/11/2026SE |
| K253665 | Vashe Plus Antimicrobial SolutionFRO · Traditional | Urgo Medical North America, LLC | 08/11/2026SE |
| K262427 | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety…FMI · Special | Hh Global Technology, Inc. | 08/10/2026SE |
| K261705 | Hair Removal Device (R3C16-G Pro, R3C16-V Pro)OHT · Special | Shenzhen Jianchao Intelligent Technology Co., Ltd. | 08/10/2026SE |
| K261602 | Eye Recovery Pro (PH-e03)OHS · Traditional | Shenzhen Goodwind Technology Development Co., Ltd. | 08/10/2026SE |
| K261576 | Icona Hip StemMEH · Traditional | Corin, Ltd. | 08/10/2026SE |
| K260176 | Mobility Scooter (W3483, W3483A)INI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 08/10/2026SE |
| K260165 | Unimpregnated Central Venous CatheterFOZ · Traditional | Spectrum Vascular | 08/10/2026SE |
| K260094 | Mobility Scooter (W3465, W3902 (S50 Carbon))INI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 08/10/2026SE |
| K254143 | EM-TECH Passive Ultrasound Probe StrapITX · Traditional | EM-TECH Solutions, Inc. | 08/10/2026SE |
| K254069 | Hemoclip (511 series, 543 series)PKL · Traditional | Hangzhou AGS MedTech Co., Ltd. | 08/10/2026SE |
| K254036 | Novii+ Wireless Patch SystemHGM · Traditional | Datex Ohmeda, Inc. | 08/10/2026SE |
| K253794 | Prostate CoreQIH · Traditional | Lucida Medical, Ltd. | 08/10/2026SE |
| K253528 | Atellica IM CA 19-9 IINIG · Traditional | Siemens Healthcare Diagnostics, Inc. | 08/10/2026SE |
| K253468 | Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A)MPA · Traditional | Nova Eye, Inc. | 08/10/2026SE |
| K262357 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Special | Arthrex, Inc. | 08/07/2026SE |
| K261937 | PacTemp Automix NEEMA · Traditional | The Belport Company Inc., DBA Gingi-Pak | 08/07/2026SE |
| K261905 | BUM OilNUC · Traditional | Bumlicious, LLC (DBA Bumlicious) | 08/07/2026SE |
| K261668 | Venue GoIYN · Traditional | GE Medical Systems Ultrasound and Primary care… | 08/07/2026SE |
| K261601 | LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)OHS · Traditional | Shenzhen Chuangtong Yigou Technology Co., Ltd. | 08/07/2026SE |
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners)JWH · Traditional | Maxx Orthopedics, Inc. | 08/07/2026SE |
| K261437 | Mistral-Air® Warming SystemDWJ · Special | The Surgical Company International B.V., doing… | 08/07/2026SE |
| K261362 | Xpert Hemorrhagic FeverQVR · Dual Track | Cepheid | 08/07/2026SE |
| K261028 | Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)FYA · Traditional | Yadu Medical (Henan) Co., Ltd. | 08/07/2026SE |
| K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R…FMI · Traditional | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 08/07/2026SE |
| K260567 | EW10-EC02 Endoscopy Support ProgramQNP · Special | Fujifilm Corporation | 08/07/2026SE |
| K254205 | Zenition 30OWB · Traditional | Philips Medical Systems Nederland B.V. | 08/07/2026SE |
| K253702 | Intuitive Endoluminal Gastrointestinal System (IG1000)FDS · Traditional | Intuitive Surgical, Inc. | 08/07/2026SE |
| K253561 | Aperio iQC DX SoftwareSIX · Traditional | Leica Biosystems Imaging, Inc. | 08/07/2026SE |
| K253554 | Aperio GT 450 DX; Aperio GT 180 DXPSY · Traditional | Leica Biosystems Imaging, Inc. | 08/07/2026SE |
| K253505 | Zamenix PFGB · Traditional | Roen Surgical, Inc. | 08/07/2026SE |
| K253453 | Metrix COVID Test; Metrix COVID Test ProQWB · Traditional | Aptitude Medical Systems, Inc. | 08/07/2026SE |
| K252571 | mdprostateQIH · Traditional | Mediaire GmbH | 08/07/2026SE |
| K251544 | Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)EIA · Traditional | Lakong Medical Devices Co., Ltd. | 08/07/2026SE |
| K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemKRO · Traditional | Howmedica Osteonics Corp. dba Stryker Orthopaedics | 08/06/2026SE |
| K261571 | Manual Wheelchair (H008, PCK7)IOR · Traditional | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 08/06/2026SE |
| K261121 | Megalodon Dynamic Compression SystemJDR · Traditional | Paragon 28, Inc. | 08/06/2026SE |
| K261059 | Overjet Multi-Image Caries and Charting AssistMYN · Traditional | Overjet, Inc. | 08/06/2026SE |
| K260223 | Aristotle Mini GuidewireMOF · Traditional | Scientia Vascular, Inc. | 08/06/2026SE |
| K254194 | QIAstat-Dx BCID GPF Plus AMR PanelPAM · Traditional | QIAGEN GmbH | 08/06/2026SE |
| K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…NHA · Traditional | Nobel Biocare AB | 08/06/2026SE |
| K253469 | Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus…FIE · Traditional | Mozarc Medical Us, LLC | 08/06/2026SE |
| K251508 | Telemetry Monitor (iT30, iT50)MHX · Traditional | Edan Instruments, Inc. | 08/06/2026SE |
| K262056 | Rusch Latex Gold Foley CatheterEZL · Traditional | Teleflex Medical Sdn. Bhd. | 08/05/2026SE |
| K261932 | Leksell® Vantage Stereotactic SystemHAW · Traditional | Elekta Solutions AB | 08/05/2026SE |
| K261456 | Ruthinium DiscPOW · Traditional | Dental Manufacturing S.p.A. | 08/05/2026SE |
| K261380 | Concentriq AP-DxQKQ · Traditional | Proscia, Inc. | 08/05/2026SE |
| K260919 | Transurethral Catheter Safety Valve (TUCSV) (80050)KNY · Traditional | Class Medical , Ltd. | 08/05/2026SE |
| K260845 | Huahong Sharps Container (HHR-I, HHR-II)MMK · Traditional | Tianjin Huahong Technology Co., Ltd. | 08/05/2026SE |
| K260737 | Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure…EZD · Traditional | Convatec | 08/05/2026SE |
| K260120 | NaturaJel Oral Wound Care KitOLR · Traditional | HCS Innovation, LLC | 08/05/2026SE |
| K254211 | pVasc Net Mechanical Thrombectomy Device · Special | Vesalio, Inc. | 08/05/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K252853 | CAD - Lower GI (EC07-01)QNP · Traditional | Xiamen Inno Medical Technology Co., Ltd. | 08/05/2026SE |
| K262311 | Alturion Series Diagnostic Ultrasound SystemIYN · Special | Philips Ultrasound, LLC | 08/04/2026SE |
| K261915 | Navigator Flex Ureteral Access Sheath SetFED · Traditional | Boston Scientific Corporation | 08/04/2026SE |
| K261851 | LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED…OHS · Traditional | Shenzhen Qianyu Technology Co., Ltd. | 08/04/2026SE |
| K261609 | Freedom Partial Knee SystemHSX · Traditional | Maxx Orthopedics, Inc. | 08/04/2026SE |
| K261523 | Vertex Thrombectomy SystemQEW · Traditional | Jupiter Endovascular | 08/04/2026SE |
| K261496 | LED Light Therapy Masks (PE748, PE749, PE756)OHS · Traditional | Duplex International Trading Limited | 08/04/2026SE |
| K260572 | Marrow MarxmanKNW · Traditional | Medimetrix, LLC | 08/04/2026SE |
| K254043 | TRIVANCE Hip StemLPH · Traditional | Globus Medical, Inc. | 08/04/2026SE |
| K253902 | RealGUIDEQIH · Traditional | 3DIEMME SRL | 08/04/2026SE |
| K253760 | OMNI Ultra Surgical System (1-110)MRH · Traditional | Sight Sciences, Inc. | 08/04/2026SE |
| K262115 | VueJect® Ultrasound Enhancing Agent Delivery SystemIZQ · Traditional | ACIST Medical Systems, Inc. | 08/03/2026SE |
| K262047 | Grappler Suture Anchor SystemMBI · Special | Paragon 28, Inc. | 08/03/2026SE |
| K261856 | Halcyon, Ethos Radiotherapy System (5.0)IYE · Traditional | Varian Medical Systems, Inc. | 08/03/2026SE |
| K261504 | PuraStat-RMPHN · Traditional | 3-D Matrix, Inc. | 08/03/2026SE |
| K261503 | PuraStat GIQAU · Traditional | 3-D Matrix, Inc. | 08/03/2026SE |
| K261408 | SABER-XA SystemOVD · Traditional | Elevation Spine | 08/03/2026SE |
| K260381 | EvePHL · Traditional | Wandercraft SAS | 08/03/2026SE |
| K260236 | XliteIZL · Traditional | Gemss Healthcare Co., Ltd. | 08/03/2026SE |
| K262681 | NanoCeram ResinEBI · Traditional | 3BFAB Teknoloji A.S. | 07/31/2026SE |
| K262253 | Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)ONN · Special | Orthalign, Inc. | 07/31/2026SE |
| K262251 | ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)JWH · Special | Globus Medical, Inc. | 07/31/2026SE |
| K261912 | SnØreNegatØrLRK · Traditional | DnB Innovations, LLC | 07/31/2026SE |
| K261854 | xvision Spine systemSBF · Traditional | Augmedics, Ltd. | 07/31/2026SE |
| K261824 | da Vinci Surgical System, Model IS5000NAY · Traditional | Intuitive Surgical, Inc. | 07/31/2026SE |
| K261810 | Vertiwedge® Intraosseous SystemMQP · Special | Foundation Surgical Group | 07/31/2026SE |
| K261809 | Interwedge® Standalone LateralOVD · Special | Foundation Surgical Group | 07/31/2026SE |
| K261494 | Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart…DQD · Traditional | Shanghai Hulu Devices Co., Ltd. | 07/31/2026SE |
| K261482 | LightStim for Wrinkles (1984); LightStim for Acne (2038)OHS · Traditional | Led Intellectual Properties, LLC | 07/31/2026SE |
| K261451 | ZSAlign Cervical Interbody SystemOVE · Traditional | ZSFab, Inc. | 07/31/2026SE |
| K261335 | VitalFlow Set with Balance BiosurfaceQJZ · Traditional | Medtronic, Inc. | 07/31/2026SE |
| K261331 | I-Genius (100019400)LNH · Traditional | Esaote, S.p.A. | 07/31/2026SE |
| K261187 | Hearing Aid FeatureSCR · Traditional | Samsung Electronics Co., Ltd. | 07/31/2026SE |
| K261183 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)ODG · Traditional | Olympus Medical Systems Corporation | 07/31/2026SE |
| K260936 | RadioViewAILLZ · Traditional | Neurocareai, Inc. (Dba Savelife.Ai) | 07/31/2026SE |
| K260852 | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureLNH · Traditional | Siemens Healthineers AG | 07/31/2026SE |
| K260607 | Shield System (Siemens 30x40)OWB · Special | Radiaction , Ltd. | 07/31/2026SE |
| K254042 | WatchPAT SWMNR · Traditional | Itamar Medical , Ltd. | 07/31/2026SE |
| K253835 | AffinityQIH · Traditional | Hermes Medical Solutions AB | 07/31/2026SE |
| K253800 | 0909FCE, 0909FCE-HSMQB · Traditional | Rayence Co., Ltd. | 07/31/2026SE |
| K253655 | Angled Screwdriver MED (M-SD090)DZI · Traditional | W&H Dentalwerk Bürmoos GmbH | 07/31/2026SE |
| K253555 | Flexitouch® Plus Advanced Pneumatic Compression SystemJOW · Traditional | Tactile Medical | 07/31/2026SE |
| K252812 | UniPearls® Embolic MicrospheresKRD · Traditional | Suzhou Haowei Medical Technology Co., Ltd. | 07/31/2026SE |
| K262369 | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair…MBI · Special | Stryker Endoscopy | 07/30/2026SE |
| K262330 | dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil…MOS · Special | Philips Medical Systems Nederland B.V. | 07/30/2026SE |
| K262239 | Obsidian® Press Over ZirconiaEIH · Special | Prismatik Dentalcraft, Inc. | 07/30/2026SE |
| K261835 | LOGIQ FocusIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 07/30/2026SE |
| K261448 | neXus Ultrasonic Surgical Aspirator SystemLFL · Traditional | Misonix, LLC | 07/30/2026SE |
| K261410 | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…OLO · Traditional | Suite 201, National Innovation Centre | 07/30/2026SE |
| K261389 | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)CCL · Traditional | Salter Labs | 07/30/2026SE |
| K261288 | Handheld Ultrasound ScannerIYN · Traditional | Imgfax Co., Ltd. | 07/30/2026SE |
| K260980 | cmAngio® V2.0QIH · Traditional | Curemetrix, Inc. | 07/30/2026SE |
| K260624 | Arthrex Radial Head Replacement SystemKWI · Traditional | Arthrex, Inc. | 07/30/2026SE |
| K260620 | SeptAlign (SPLN001)NHB · Traditional | Spirair, Inc. | 07/30/2026SE |
| K260566 | SMARTVERTIGO Vestibular Assessment SystemGWN · Traditional | VertigoDx, Inc. | 07/30/2026SE |
| K260161 | SmartGuide Disposable Guides and GridsITX · Traditional | UC-CARE , Ltd. | 07/30/2026SE |
| K254038 | Motivista (CT-155)SAP · Traditional | Click Therapeutics, Inc. | 07/30/2026SE |
| K252042 | Sync AV II Temporary Pacing CatheterLDF · Traditional | Swift Sync, Inc. | 07/30/2026SE |
| K251959 | TnR Cranial ImplantGXP · Traditional | T&R BIOFAB CO., Ltd. | 07/30/2026SE |
| K262240 | SSPC NXT Delivery CatheterDQY · Special | CenterPoint Systems, LLC | 07/29/2026SE |
| K262200 | Stone Clear (BWSC-LP9-02)QNA · Special | Sonomotion, Inc. | 07/29/2026SE |
| K261829 | Profoject Dual-Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 07/29/2026SE |
| K261770 | Suture Button Repair SystemMBI · Traditional | Skeletal Dynamics, Inc. | 07/29/2026SE |
| K261766 | CPS Locator 3D Plus Delivery CatheterDQY · Special | CenterPoint Systems, LLC | 07/29/2026SE |
| K261210 | Cleerly PlaqueQIH · Traditional | Cleerly, Inc. | 07/29/2026SE |
| K261205 | SPINEART Navigation Instrument SystemOLO · Traditional | Spineart SA | 07/29/2026SE |
| K261058 | CraniUS PlateGWO · Traditional | CraniUS, LLC | 07/29/2026SE |
| K260588 | Cleerly LABSLLZ · Traditional | Cleerly, Inc. | 07/29/2026SE |
| K253526 | NAMIC Dilator and SheathDYB · Traditional | Medline Industries, LP | 07/29/2026SE |
| K251908 | Emanate TrayOLR · Traditional | Emanate Biomedical | 07/29/2026SE |
| K261511 | Xpert AnkleHRS · Traditional | Newclip Technics | 07/28/2026SE |
| K261430 | TruLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 07/28/2026SE |
| K261427 | uMI Panvivo (uMI Panvivo M)KPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 07/28/2026SE |
| K261412 | V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…IYN · Traditional | Samsung Medison Co., Ltd. | 07/28/2026SE |
| K261399 | Elisio-HxQAX · Traditional | Nipro Medical Corporation | 07/28/2026SE |
| K260558 | Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl…KGO · Traditional | Hartalega NGC Sdn. Bhd. | 07/28/2026SE |
| K260326 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)FMZ · Traditional | Datex-Ohmeda, Inc. | 07/28/2026SE |
| K260303 | See-Mode Augmented Reporting Tool, Breast (SMART-B)QDQ · Traditional | See-Mode Technologies Pty, Ltd. | 07/28/2026SE |
| K253651 | Revi SystemQXM · Traditional | Bluewind Medical , Ltd. | 07/28/2026SE |
| K253450 | BodyTom Elite (NL4000)JAK · Traditional | NeuroLogica Corp., a Samsung Company | 07/28/2026SE |
| K262474 | ND Needle Guidance SystemITX · Traditional | Accurate Access, LLC | 07/27/2026SE |
| K262201 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…PPN · Special | Shockwave Medical, Inc. | 07/27/2026SE |
| K261759 | Euphora Rapid Exchange (RX) Balloon Dilatation CatheterLOX · Traditional | Medtronic Ireland | 07/27/2026SE |
| K261310 | FlexTract Deflectable-Rotational Dilator Sheath SetDRE · Traditional | Merit Medical Systems, Inc. | 07/27/2026SE |
| K261211 | Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…IYN · Traditional | Philips Ultrasound, LLC | 07/27/2026SE |
| K261105 | Powered Aventus Thrombectomy SystemQEZ · Traditional | Inquis Medical | 07/27/2026SE |
| K260835 | ARCHIMEDES Biodegradable Stent (Medium)FGE · Traditional | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | 07/27/2026SE |
| K260529 | Air Compression Massager (HY-1165)IRP · Traditional | Xiamen High Top Electronic Technology Co., Ltd. | 07/27/2026SE |
| K250419 | Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange)…OSD · Traditional | Plus EV Holdings, Inc. D/B/A Intimate Rose | 07/27/2026SE |
| K261367 | Corsano CardioWatch 287-2 SystemMSX · Traditional | Corsano Health B.V. | 07/26/2026SE |
| K253576 | CorVista System® with PCWP Add-OnDQK · Traditional | Analytics For Life, Inc. | 07/26/2026SE |
| K260382 | MONARCH Platform (MON-000008)EOQ · Traditional | Auris Health, Inc. | 07/25/2026SE |
| K253206 | METICULY Patient-specific CMF solutionJEY · Traditional | Meticuly Co., Ltd. | 07/25/2026SE |
| K262462 | TheraSphere 360 Y-90 Management PlatformLLZ · Special | Boston Scientific Corporation | 07/24/2026SE |
| K262383 | LumenCare AzureJAQ · Special | Nucletron B.V. | 07/24/2026SE |
| K262294 | dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes…MOS · Special | Philips Medical Systems Nederland B.V. | 07/24/2026SE |
| K262290 | REMEDY POLY+PLUS SNAP FIT Acetabular CupKWL · Special | Osteoremedies, LLC | 07/24/2026SE |
| K262165 | FARADRIVE Steerable Sheath (M004PF21M402)DRA · Special | Boston Scientific Corporation | 07/24/2026SE |
| K262152 | VS-370CF, VS-370CTFCX · Traditional | VISION MEDICAL Co., Ltd. | 07/24/2026SE |
| K262121 | Ion-L Navigated InstrumentsOLO · Special | SurGenTec, LLC | 07/24/2026SE |
| K261849 | VERAFEYE Imaging Catheter (VF-VIC-002)OBJ · Special | Luma Vision Limited | 07/24/2026SE |
| K261781 | Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60JTN · Traditional | Thermo Fisher Scientific (Oxoid Ltd.) | 07/24/2026SE |
| K261488 | OBSIDIO Conformable EmbolicKRD · Traditional | Boston Scientific Corporation | 07/24/2026SE |
| K261364 | Atellica CH Acetaminophen 2 (ACTM)LDP · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/24/2026SE |
| K261349 | SwiftMRQIH · Traditional | Airs Medical, Inc. | 07/24/2026SE |
| K261312 | Temporary Keratoprosthesis (QuickSet TKP)MLP · Traditional | Eyekon Medical, Inc. | 07/24/2026SE |
| K261274 | EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…KTI · Traditional | Cook Ireland, Ltd. | 07/24/2026SE |
| K261267 | Careflux H60;Careflux H70;Careflux V500KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 07/24/2026SE |
| K261221 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed…GEX · Traditional | Olympus Surgical Technologies America | 07/24/2026SE |
| K261027 | NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent…DHB · Traditional | Hycor Biomedical | 07/24/2026SE |
| K261024 | TMINI Miniature Robotic SystemOLO · Traditional | THINK Surgical, Inc. | 07/24/2026SE |
| K261014 | Accuro® 3S Needle Guide KitITX · Traditional | Rivanna Medical, Inc. | 07/24/2026SE |
| K260948 | Air Compression Massager (EP30B001 I)IRP · Traditional | Wavepulse (Xiamen) Healthcare Technology Co., Ltd. | 07/24/2026SE |
| K260598 | 5 Wavelength LED Facemask (TN2508)OHS · Traditional | iSMART Developments, Ltd. | 07/24/2026SE |
| K260362 | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…NKB · Traditional | MANTIZ Co., Ltd. | 07/24/2026SE |
| K260259 | DiscreetDuo Flow Wearable Breast Pump (Model S3)HGX · Traditional | Shenzhen TPH Technology Co., Ltd. | 07/24/2026SE |
| K260192 | DianaQIH · Traditional | ROPCA ApS | 07/24/2026SE |
| K254180 | PerfusiX-ImagingOWN · Traditional | LIMIS Development B.V. | 07/24/2026SE |
| K253943 | Tiger 2 SystemNKB · Traditional | Zavation Medical Products, LLC | 07/24/2026SE |
| K253703 | RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionFRN · Traditional | Deka R&D Corp | 07/24/2026SE |
| K253541 | EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ…GCJ · Traditional | Medical Impact | 07/24/2026SE |
| K253452 | Accuro 3SIYO · Traditional | Rivanna Medical, Inc. | 07/24/2026SE |
| K253277 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX · Traditional | Ge Medical Systems Information Technologies, Inc. | 07/24/2026SE |
| K252370 | GEN 4 JOY WheelchairIOR · Traditional | Free Wheelchair Mission | 07/24/2026SE |
| K262143 | ImageGrid StreamVueLLZ · Traditional | Candelis, Inc. | 07/23/2026SE |
| K262116 | TRUE METRIX Self Monitoring Blood Glucose SystemNBW · Special | Trividia Health, Inc. | 07/23/2026SE |
| K261853 | Gepotidacin GEP 10 µgJTN · Traditional | Liofilchem, Inc. | 07/23/2026SE |
| K261748 | Dental Cone-beam Computed Tomography (mDX-15P Series)OAS · Traditional | Hefei Meyer Optoelectronic Technology, Inc. | 07/23/2026SE |
| K261734 | Klassic Infection Spacer SystemJWH · Traditional | Total Joint Orthopedics, Inc. | 07/23/2026SE |
| K261694 | CORE 300 Digital StethoscopeDQD · Traditional | Eko Health, Inc. | 07/23/2026SE |
| K261644 | Perfadex PlusKDN · Traditional | Xvivo Perfusion AB | 07/23/2026SE |
| K261272 | ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…IYN · Traditional | Esonic Technology (Wuhan) Co., Ltd. | 07/23/2026SE |
| K261136 | Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)DXN · Traditional | Guangzhou Daxin Health Technology Co., Ltd. | 07/23/2026SE |
| K261082 | Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)DXN · Traditional | Microlife Corporation | 07/23/2026SE |
| K261081 | Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)IYN · Special | Beijing Konted Medical Technology Co.,Ltd | 07/23/2026SE |
| K254096 | VELMENI for DENTISTS (V4D) 3DQIH · Traditional | Velmeni, Inc. | 07/23/2026SE |
| K253932 | FACEGYM Pro Device (HD-109)NFO · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 07/23/2026SE |
| K253044 | RXiBreeze PAP System (RXiBreeze 20C)BZD · Traditional | Resvent Medical Technology Co., Ltd. | 07/23/2026SE |
| K253041 | 3d Cage CervicalODP · Traditional | Fims Co., Ltd. | 07/23/2026SE |
| K251576 | Total Flow Medical Femoral Arterial (TFA) cannulaSFF · Traditional | Total Flow Medical Limited | 07/23/2026SE |
| K262211 | LancetQRL · Special | Tianjin Huahong Technology Co., Ltd. | 07/22/2026SE |
| K262094 | E3D-C Interbody SystemOVE · Special | Evolution Spine | 07/22/2026SE |