Syringe, Piston
FDA product code FMF · Class II (moderate risk) · 21 CFR 880.5860 · General Hospital
752510(k) clearances
0PMA approvals
279recalls
Manufacturers
- Bd Becton Dickinson Vacutainer Systems Preanalytic 23
- Sherwood Medical Co. 20
- Becton, Dickinson and Company 14
- Merit Medical Systems, Inc. 10
- Terumo Medical Corp. 10
- Nipro Medical Corporation 9
- Mac Lee Medical Products 7
- Abco Dealers, Inc. 7
- Promisemed Hangzhou Meditech Co., Ltd. 7
- Sol-Millennium Medical, Inc. 7
- SurGenTec, LLC 6
- Eli Lilly and Company 6
- Confluent Surgical,Inc 6
- Concord Laboratories, Inc. 6
- Baxter Healthcare Corp 6
- B. Braun Medical, Inc. 6
- Becton Dickinson & Co. 5
- Can-Am Surgical Corp. 4
- ICU Medical, Inc. 4
- Biosurgical Corp. 4
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262581 | GraftGun Universal Graft Delivery System (GDS®)FMF · Special | SurGenTec, LLC | 08/26/2026SE |
| K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle TrayFMF · Traditional | Sol-Millennium Medical, Inc. | 08/25/2026SE |
| K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03)FMF · Traditional | Jiangsu Enjosim Medical Technology Co., Ltd. | 08/14/2026SE |
| K260208 | Ultra-Fine SAFETY Insulin SyringeFMF · Traditional | embecta Medical II, LLC | 07/13/2026SE |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeFMF · Traditional | Sol-Millennium Medical, Inc. | 06/18/2026SE |
| K260514 | Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead…FMF · Traditional | CMT Health PTE., Ltd. | 06/12/2026SE |
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…FMF · Special | Hlb Lifescience Co., Ltd. | 05/21/2026SE |
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)FMF · Traditional | Chirana T.Injecta,A.S. | 04/17/2026SE |
| K253068 | Profoject Insulin Syringes; Profoject Safelock Disposable Insulin SyringeFMF · Traditional | CMT Health PTE., Ltd. | 02/23/2026SE |
| K253769 | Instylla Delivery KitFMF · Special | Instylla, Inc. | 12/22/2025SE |
| K252518 | DuoprossTM Smart Cap (Type I)FMF · Traditional | Duopross Meditech Corporate | 12/17/2025SE |
| K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe…FMF · Traditional | Exelint International, Co. | 12/12/2025SE |
| K250192 | Verisafe Safety Retractable Insulin SyringesFMF · Traditional | Promisemed Hangzhou Meditech Co., Ltd. | 12/10/2025SE |
| K250853 | Merit SyringeFMF · Special | Merit Medical Systems, Inc. | 11/04/2025SE |
| K250510 | Sure-Fine Insulin SyringesFMF · Special | Shina Med Corporation | 10/15/2025SE |
| K243660 | Monoject 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject 3mL Syringe…FMF · Traditional | Cardinalhealth | 08/22/2025SE |
| K251350 | BD Plastipak SyringeFMF · Traditional | Becton, Dickinson and Company | 07/29/2025SE |
| K252033 | Profoject Disposable Syringe, Profoject Disposable Syringe with NeedleFMF · Traditional | CMT Health PTE., Ltd. | 07/25/2025SE |
| K250733 | 3DOSE 1ml SyringeFMF · Traditional | Bimed Teknik Aletler Sanayi & Ticaret A.S. | 07/03/2025SE |
| K251648 | GPS Advanced; GPS Advanced CannulaFMF · Special | Prosidyan, Inc. | 06/24/2025SE |
| K250262 | Go-Pen®FMF · Traditional | Go-Pen Aps | 04/24/2025SE |
| K243580 | GraftGun Universal Graft Delivery System (GDS)FMF · Traditional | SurGenTec, LLC | 02/05/2025SE |
| K242434 | Insulin SyringesFMF · Special | Chirana T. Injecta | 12/24/2024SE |
| K241856 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…FMF · Special | Hlb Lifescience Co., Ltd. | 12/23/2024SE |
| K242099 | Sol-M Slip Tip Syringe without Needle, Sol-M Eccentric Tip Syringe without NeedleFMF · Traditional | Sol-Millennium Medical, Inc. | 10/22/2024SE |
| K241821 | Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer…FMF · Traditional | Sol-Millennium Medical, Inc. | 09/20/2024SE |
| K231095 | Tamper Evident CapFMF · Traditional | International Medical Industries, Inc. | 09/04/2024SE |
| K240961 | Disposable Pen Injector AssemblyFMF · Traditional | Wuxi Nest Biotechnology Co., Ltd. | 08/15/2024SE |
| K241426 | GPS Advanced; 5 cc GPS Advanced CannulaFMF · Traditional | Prosidyan, Inc. | 07/10/2024SE |
| K233368 | Allograft Delivery Device (OFAC-C)FMF · Traditional | Bioventus, LLC | 06/25/2024SE |
| K240774 | Pen InjectorFMF · Traditional | Wuxi Nest Biotechnology Co., Ltd. | 06/18/2024SE |
| K232950 | Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable…FMF · Traditional | Perfect Medical Industry (Vn) Co., Ltd. | 06/12/2024SE |
| K234024 | HWJECT Auto-disable syringeFMF · Traditional | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 03/19/2024SE |
| K233794 | Insulin SyringeFMF · Traditional | Spm Medicare Pvt. , Ltd. | 03/06/2024SE |
| K230235 | Medline Luer Lock SyringesFMF · Traditional | Medline Industries, LP | 02/16/2024SE |
| K231558 | SMB Luer lock disposable syringeFMF · Traditional | Smb Corporation of India | 01/12/2024SE |
| K231877 | NavaClick Injection SystemFMF · Traditional | Lineage Biomedical, Inc. | 11/30/2023SE |
| K230061 | Insulin SyringeFMF · Traditional | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 11/30/2023SE |
| K231519 | Revital CadyFMF · Traditional | Revital Healthcare (Epz) Limited | 11/06/2023SE |
| K233056 | EpiZactFMF · Traditional | Guidestar Medical Devices | 11/02/2023SE |
| K221777 | Disposable Sterile SyringeFMF · Traditional | Weihai Shengjie Medical Technology Co., Ltd. | 10/06/2023SE |
| K231792 | VeriSafe Safety sterile syringesFMF · Traditional | Promisemed Hangzhou Meditech Co., Ltd. | 09/28/2023SE |
| K231888 | BD Texium Needle-Free SyringeFMF · Traditional | Care Fusion | 09/25/2023SE |
| K231727 | Sterile Auto-Disable Syringes with/without Needle for Single UseFMF · Traditional | Wepon Medical Technology Co., Ltd. | 09/08/2023SE |
| K231900 | A-TAP (previously called Arthrotap)FMF · Special | Elcam Medical Acal | 07/25/2023SE |
| K222925 | Hypodermic Syringes & NeedleFMF · Traditional | Lifelong Meditech Private Limited | 07/18/2023SE |
| K231456 | Avitus® DragonWing Large Volume Autograft Delivery SystemFMF · Traditional | Avitus Orthopaedics, Inc. | 07/17/2023SE |
| K230492 | Avitus® Precision Autograft Delivery SystemFMF · Traditional | Avitus Orthopaedics, Inc. | 06/26/2023SE |
| K212857 | Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single UseFMF · Traditional | Jiangsu Zhiyu Medical Instrument Co, Ltd. | 05/09/2023SE |
| K220713 | Sol-Guard Auto-disable SyringeFMF · Traditional | Sol-Millennium Medical, Inc. | 05/04/2023SE |
| K221974 | EpiFinderFMF · Traditional | Omeq Medical , Ltd. | 04/16/2023SE |
| K212207 | Sterile Hypodermic Syringe for Single UseFMF · Traditional | Shandong Weigao Group Medical Polymer Co., Ltd. | 03/23/2023SE |
| K222672 | Disposable Insulin SyringeFMF · Traditional | Hantech Medical Device Co., Ltd. | 03/06/2023SE |
| K223453 | Insulin SyringeFMF · Traditional | Promisemed Hangzhou Meditech Co., Ltd. | 03/02/2023SE |
| K221702 | CompuFlo Epidural Computer Controlled Anesthesia SystemFMF · Traditional | Milestone Scientific, Inc. | 02/25/2023SE |
| K212635 | SofjecFMF · Traditional | Hwajin Medical Co., Ltd. | 02/13/2023SE |
| K223678 | Sterile Syringes for Single UseFMF · Traditional | Shanghai Kindly Enterprise Development Group… | 02/09/2023SE |
| K203211 | Insulin syringe with integrated needle DLFMF · Traditional | Dlp Medical Products, Corp. | 02/09/2023SE |
| K213054 | Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety SyringeFMF · Traditional | Medline Industries, Inc. | 12/09/2022SE |
| K212764 | Medwell Technology Ltd Syringes, various sizesFMF · Traditional | Medwell Technology, Ltd. | 11/04/2022SE |
| K221045 | Insulin Syringes without needleFMF · Traditional | Berpu Medical Technology Co., Ltd. | 11/03/2022SE |
| K221308 | Disposable Syringe with permanently attached needle, Safety Syringe with permanently…FMF · Traditional | Jiangxi Maidikang Medical Devices Co., Ltd. | 10/17/2022SE |
| K222744 | Sol-M Luer Lock SyringeFMF · Special | Sol-Millennium Medical, Inc. | 10/11/2022SE |
| K221079 | Sterile Hypodermic Syringes for Single UseFMF · Traditional | Sichuan Prius Biotechnology Co., Ltd. | 10/04/2022SE |
| K221068 | Sterile Hypodermic Syringes for Single Use with NeedlesFMF · Traditional | Sichuan Prius Biotechnology Co., Ltd. | 10/04/2022SE |
| K212846 | Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic…FMF · Traditional | Jiangsu Jichun Medical Devices Co., Ltd. | 08/30/2022SE |
| K212033 | Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin…FMF · Traditional | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 08/17/2022SE |
| K221737 | InstaFill Graft Delivery System, SIGNIFY BioactiveFMF · Traditional | Globus Medical, Inc. | 08/11/2022SE |
| K220184 | Pump Alignment SyringeFMF · Traditional | Jiangsu Caina Medical Co.,Ltd | 07/21/2022SE |
| K213158 | Syringe with permanently attached needleFMF · Traditional | Berpu Medical Technology Co., Ltd. | 07/21/2022SE |
| K220204 | Disposabel Syringe with permanently attached needle, Safety Syringe with permanently…FMF · Traditional | Anhui Tiankang Medical Technology Co., Ltd. | 07/14/2022SE |
| K213811 | Sterile Hypodermic Syringes for Single UseFMF · Traditional | Berpu Medical Technology Co., Ltd. | 05/12/2022SE |
| K212677 | aboNT SYRINGEFMF · Traditional | Nipro Medical Corporation | 04/15/2022SE |
| K213560 | Verifine Safety Syringe with Fixed NeedleFMF · Traditional | Promisemed Hangzhou Meditech Co., Ltd. | 04/05/2022SE |
| K203738 | QitexioFMF · Traditional | Medex | 03/14/2022SE |
| K212920 | Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for…FMF · Traditional | Shandong Weigao Group Medical Polymer Co., Ltd. | 03/11/2022SE |
| K212499 | BD Insulin Syringe (0.3mL)FMF · Traditional | Becton, Dickinson and Company | 03/09/2022SE |
| K210848 | Sure-Fine Insulin SyringesFMF · Special | Shina Med Corporation | 03/01/2022SE |
| K213632 | Instylla Delivery KitFMF · Special | Instylla, Inc. | 02/10/2022SE |
| K211210 | Sterile Auto-Disable Syringes with/without Needle for Single UseFMF · Traditional | Azur Medical Company, Inc. | 01/27/2022SE |
| K211482 | Disposable Syringe with NeedleFMF · Traditional | Shandong Qinkai Medical Industry Co., Ltd. | 01/24/2022SE |
| K201044 | CHIRANA Insulin SyringesFMF · Traditional | Chirana T. Injecta | 01/18/2022SE |
| K210914 | Sterile Syringe for Single UseFMF · Traditional | Jiangsu Suyun Medical Material Co., Ltd. | 12/17/2021SE |
| K212544 | MiniLoad SyringeFMF · Special | Ocuject, LLC | 10/13/2021SE |
| K211211 | Sterile syringes for single use with/without needleFMF · Traditional | Azur Medical Company, Inc. | 10/07/2021SE |
| K211728 | Sterile hypodermic syringes for single useFMF · Traditional | Jiangsu Kangyou Medical Instrument Co., Ltd. | 10/05/2021SE |
| K210818 | TrueCare Biomedix Tamper Evident CapFMF · Traditional | Us Infusion Inc. D/B/A Truecare Biomedix-USA | 09/15/2021SE |
| K210227 | Sterile syringe for single use with/without needleFMF · Traditional | Zhejiang Kangkang Medical-Devices Co., Ltd. | 09/10/2021SE |
| K211242 | Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic SyringesFMF · Traditional | Promisemed Hangzhou Meditech Co., Ltd. | 09/09/2021SE |
| K210712 | Verifine Mechanical Safety Insulin SyringeFMF · Traditional | Promisemed Hangzhou Meditech Co., Ltd. | 09/08/2021SE |
| K210997 | PreferX Delivery SystemFMF · Traditional | Md3, LLC | 09/07/2021SE |
| K210991 | Disposable Sterile Syringe, Disposable Sterile Syringe with NeedleFMF · Traditional | Guangdong Antmed Co., Ltd. | 08/26/2021SE |
| K210464 | Auto Disable SyringeFMF · Traditional | Anhui Tiankang Medical Technology Co., Ltd. | 08/24/2021SE |
| K203359 | BD Flu+ SyringeFMF · Traditional | Becton, Dickinson and Company | 07/28/2021SE |
| K210103 | Safeway, Lifelong Premium, Lifelong MatrixFMF · Traditional | Lifelong Meditech Private Limited | 07/16/2021SE |
| K210200 | 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-LockFMF · Special | Set Medikal Sanayi VE Ticaret Anonim Sirketi | 05/14/2021SE |
| K203264 | MicroDose InjectorFMF · Traditional | Medone Surgical, Inc. | 04/26/2021SE |
| K202432 | MiniLoad SyringeFMF · Traditional | Ocuject, LLC | 02/19/2021SE |
| K203453 | BD Hypodermic SyringeFMF · Traditional | Becton, Dickinson and Company | 01/25/2021SE |
| K201930 | Nanum SyringeFMF · Traditional | Nanum Company Co., Ltd. | 01/17/2021SE |
| K202544 | Instylla Delivery KitFMF · Special | Instylla, Inc. | 01/07/2021SE |
| K193273 | Insulin SyringeFMF · Traditional | Promisemed Hangzhou Meditech Co., Ltd. | 01/05/2021SE |
| K192770 | S dispensing lineFMF · Traditional | Aea Srl | 12/17/2020SE |
| K201284 | Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile…FMF · Abbreviated | Set Medikal Sanayi VE Ticaret Anonim Sirketi | 12/14/2020SE |
| K201816 | ArthrotapFMF · Traditional | Accuro Technologies, Inc. | 10/16/2020SE |
| K201900 | 3D GraftRasp SystemFMF · Traditional | Surgentec | 09/03/2020SE |
| K193526 | Syringe with safety needle, Safety needleFMF · Traditional | Jiangsu Caina Medical Co.,Ltd | 07/17/2020SE |
| K201234 | BD SoloShot Mini Syringe/ BD Auto Disable SyringeFMF · Traditional | Becton, Dickinson and Company | 07/15/2020SE |
| K200325 | Orbit Subretinal Delivery SystemFMF · Traditional | Orbit Biomedical | 07/14/2020SE |
| K201338 | Allograft MIS Delivery SystemFMF · Traditional | Lifenet Health | 07/13/2020SE |
| K200629 | Aspire Mechanical Aspirator GFMF · Special | Control Medical Technology | 05/29/2020SE |
| K200431 | 3D GraftRasp SystemFMF · Traditional | Surgentec | 05/18/2020SE |
| K200606 | O-Genesis Graft Delivery SystemFMF · Traditional | Orthofix, Inc. | 05/01/2020SE |
| K193101 | Omnifix Low Dead Space Luer Lock SyringeFMF · Traditional | B.Braun Medical, Inc. | 03/05/2020SE |
| K192674 | Mixing and Delivery SystemFMF · Traditional | Bone Solutions, Inc. | 02/18/2020SE |
| K193192 | Tamper Evident CapFMF · Special | International Medical Industries, Inc. | 01/31/2020SE |
| K191642 | TK Sterile Piston Syringe without NeedleFMF · Traditional | Anhui Tiankang Medical Technology Co., Ltd. | 01/06/2020SE |
| K190054 | BD Insulin SyringeFMF · Traditional | Becton, Dickinson and Company | 10/21/2019SE |
| K191659 | Instylla Delivery KitFMF · Traditional | Instylla, Inc. | 10/10/2019SE |
| K191359 | Nipro SyringeFMF · Traditional | Nipro Medical Corporation | 10/09/2019SE |
| K192421 | EpiFaith SyringeFMF · Special | Flat Medical Co., Ltd. | 09/27/2019SE |
| K190002 | Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe…FMF · Traditional | Shanghai Kohope Medical Devices Co., Ltd. | 09/12/2019SE |
| K191531 | Sure-Fine Insulin SyringesFMF · Special | Shina Med Corporation | 09/06/2019SE |
| K182765 | 5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial…FMF · Traditional | Top Corporation | 09/03/2019SE |
| K190996 | Bonus Therapeutics Mixing and Delivery SystemFMF · Traditional | Bonus Therapeutics , Ltd. | 07/28/2019SE |
| K190427 | ImmuciseFMF · Traditional | Terumo Corporation | 07/18/2019SE |
| K182268 | EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)FMF · Traditional | Flat Medical Co., Ltd. | 04/05/2019SE |
| K182589 | BD Plastipak SyringeFMF · Traditional | Becton, Dickinson and Company | 03/14/2019SE |
| K182387 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)FMF · Traditional | Novo Nordisk, Inc. | 12/17/2018SE |
| K182274 | Orbit Subretinal Delivery SystemFMF · Traditional | Orbit Biomedical, Inc. | 11/20/2018SESK |
| K182279 | Merit SyringeFMF · Abbreviated | Merit Medical Systems, Inc. | 11/06/2018SE |
| K182216 | Merit SyringeFMF · Abbreviated | Merit Medical Systems, Inc. | 11/06/2018SE |
| K172670 | BD Single Use, Hypodermic SyringeFMF · Traditional | Becton, Dickinson and Company | 10/23/2018SE |
| K180937 | Graftgun Universal Graft Delivery SystemFMF · Special | SurGenTec, LLC | 05/10/2018SE |
| K173029 | Nipro SyringeFMF · Traditional | Nipro Medical Corporation | 03/30/2018SE |
| K173601 | Merit SyringeFMF · Abbreviated | Merit Medical Systems, Inc. | 01/31/2018SE |
| K173385 | Graft Delivery, DePuy SynthesFMF · Special | Micromedics, Inc. (D/B/A Nordson Medical) | 11/30/2017SE |
| K170900 | DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6…FMF · Traditional | Intervene Group, Ltd. | 11/09/2017SE |
| K171131 | MHC Standard and NRFit Tip SyringesFMF · Traditional | Mazza Healthcare, LLC | 11/08/2017SE |
| K171805 | Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 mlFMF · Special | Conceptomed AS | 09/08/2017SE |
| K171362 | Merit SyringeFMF · Abbreviated | Merit Medical Systems, Inc. | 08/07/2017SE |
| K170675 | Graftgun Universal Graft Delivery SystemFMF · Traditional | SurGenTec, LLC | 07/19/2017SE |
| K161883 | CompuFlo Epidural Computer Controlled Anesthesia SystemFMF · Traditional | Milestone Scientific, Inc. | 06/09/2017SE |
| K170386 | BD Ultra-Fine Insulin Syringe, BD Ultra-Fine II Insulin Syringe, BD Insulin Syringes…FMF · Special | Becton Dickinson & Company | 04/12/2017SE |
| K161812 | Freedom SyringeFMF · Abbreviated | Procedure Products, Inc. | 03/27/2017SE |
| K163161 | Sterile Single-use Syringe with NeedleFMF · Traditional | Jiangxi Hongda Medical Equipment Group , Ltd. | 03/20/2017SE |
| K170218 | Vesco Medical NRFit Tip SyringesFMF · Traditional | Vesco Medical, LLC | 02/24/2017SE |
| K161606 | Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSHFMF · Traditional | Terumo Europe N.V. | 02/10/2017SE |
| K162057 | ConceptoMed Luer-Jack Slip 10mlFMF · Traditional | Conceptomed AS | 01/11/2017SE |
| K162180 | Disposable Insulin SyringeFMF · Traditional | Berpu Medical Technology Co., Ltd. | 12/29/2016SE |
| K162081 | BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD…FMF · Traditional | Becton, Dickinson and Company | 12/19/2016SE |
| K162602 | NovoPen EchoFMF · Special | Novo Nordisk, Inc. | 10/18/2016SE |
| K161568 | Bone Solutions Mixing and Delivery SystemFMF · Traditional | Bone Solutions, Inc. | 09/16/2016SE |
| K152879 | Sure-Fine Insulin SyringesFMF · Traditional | Shina Med Corporation | 09/09/2016SE |
| K160629 | InPenFMF · Traditional | Companion Medical, Inc. | 07/26/2016SE |
| K152803 | Sungshim Sterile Single Use Insulin SyringeFMF · Traditional | Sung Shim Medicare Co., Ltd. | 07/12/2016SE |
| K160978 | LITe BIO Delivery SystemFMF · Traditional | Stryker Corporation | 07/08/2016SE |
| K151870 | BD U-500 Insulin SyringeFMF · Traditional | Becton, Dickinson and Company | 07/08/2016SE |
| K153537 | Sol-M Insulin Syringe, Sol-M TB SyringeFMF · Traditional | Sol-Millennium Medical, Inc. | 06/17/2016SE |
| K160668 | HumaPen SavvioFMF · Traditional | Eli Lilly and Company, Inc. | 06/03/2016SE |
| K153553 | SiO2 Coated syringe 3 mlFMF · Traditional | Sio2 Medical Products | 05/17/2016SE |
| K151686 | HumanPen Ergo IIFMF · Traditional | Eli Lilly and Company, Inc. | 12/30/2015SE |
| K152783 | Merit 20 mL SyringeFMF · Special | Merit Medical Systems, Inc. | 12/07/2015SE |
| K151777 | Intradermal AdapterFMF · Traditional | West Pharmaceutical Services, Inc. | 09/29/2015SE |
| K151766 | BD Single Use, Hypodermic SyringeFMF · Special | Becton, Dickinson and Company | 09/02/2015SE |
| K150874 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)FMF · Special | Novo Nordisk, Inc. | 07/31/2015SE |
| K151543 | Graft Delivery Device with Integrated StyletFMF · Special | Micromedics, Inc. (D/B/A Nordson Medical) | 07/07/2015SE |
| K142518 | HumaPen LuxuraFMF · Traditional | Eli Lilly and Company | 06/05/2015SE |
| K142535 | ConMed Mixing and Delivery KitFMF · Traditional | Conmed Corporation | 04/23/2015SE |
| K143757 | ANUTRA Feedback Aspiration SyringeFMF · Traditional | Anutra Medical, Inc. | 01/08/2015SE |
| K143488 | InFill Graft Delivery SystemFMF · Special | Pinnacle Spine Group, LLC | 12/17/2014SE |
| K142661 | Bi-Portal Bone Graft Delivery DeviceFMF · Traditional | Spinal Surgical Strategies, LLC | 12/11/2014SE |
| K142636 | Merit 10mL SyringeFMF · Special | Merit Medical Systems, Inc. | 10/17/2014SE |
| K140710 | Biomet Graft Delivery SyringesFMF · Traditional | Biomet Spine (Aka Ebi, LLC) | 09/04/2014SE |
| K141762 | Perfuse Percutaneous Decompression SystemFMF · Traditional | Biomet, Inc. | 08/27/2014SE |
| K141245 | Etex Mixing and Delivery SystemFMF · Traditional | Etex Corporation | 07/09/2014SE |
| K140194 | Namic RCS SyringeFMF · Abbreviated | Navilyst Medical, Inc. | 04/14/2014SE |
| K133493 | Single Use Sterile Syringe with NeedleFMF · Abbreviated | Jiangxi Kelun Medical Devices Manufacturing Co.,Lt | 03/27/2014SE |
| K132011 | Apoteca Dug Compounding Dosing Device,Apoteca I.V. Transfer SetFMF · Abbreviated | Aea Srl | 03/21/2014SE |
| K132553 | U&U Sterile Piston Syringe Without NeedleFMF · Traditional | U&U Medical Technology Co, Ltd. | 02/27/2014SE |
| K132321 | JMS SyringeFMF · Traditional | JMS North America Corporation | 02/20/2014SE |
| K133021 | Mixing Syringe SystemFMF · Traditional | Zimmer Knee Creations, Inc. | 01/13/2014SE |
| K132120 | WTF Secura Syringe and NeedleFMF · Traditional | Beijing Wantefu Medical Apparatus Co., Ltd. | 12/12/2013SE |
| K130230 | Sterile Piston Hypodermic Syringes (With/Without Needle), Hypodermic NeedlesFMF · Traditional | Wuxi Yushou Medical Applicances Co., Ltd. | 11/20/2013SE |
| K131661 | Infusion Syringe SetFMF · Traditional | Innovative Medical Manufacturing Co. | 11/05/2013SE |
| K131963 | Tautona Injector DeviceFMF · Traditional | Tautona Group, LLC | 10/22/2013SE |
| K124037 | Jung Rim Single Use Hypodermic Syringe with NeedleFMF · Traditional | Jung Rim Medical Industrial Co., Ltd. | 09/12/2013SE |
| K131641 | Monoject 60ML Syringe (Luer Lock Tip, Luer Slip Tip, Catheter Tip)FMF · Traditional | Nipro Medical Corporation | 08/28/2013SE |
| K123766 | Novopen Echo, a Dial a Dose Insulin Delivery PenFMF · Traditional | Novo Nordisk, Inc. | 08/15/2013SE |
| K130900 | Evicel Application DeviceFMF · Traditional | Ethicon Inc (On Behalf of Omrix Biopharaceuticals | 08/13/2013SE |
| K123710 | Unitox Botox SyringeFMF · Traditional | Bio-Med USA, Inc. | 05/09/2013SE |
| K122416 | Artiglass L. O.R. Glass SyringeFMF · Traditional | Artiglass Srl | 05/03/2013SE |
| K123588 | Intradermal AdapterFMF · Traditional | West Pharmaceutical Services, Inc. | 02/19/2013SE |
| K130049 | Monoject 12ML SyringeFMF · Special | Nipro Medical Corporation | 02/14/2013SE |
| K122787 | Comfort EzFMF · Traditional | Simple Diagnostics, Inc. | 12/06/2012SE |
| K122122 | Regen Spray Applicator,FMF · Traditional | Regen Lab SA | 11/09/2012SE |
| K122023 | Mixject with Spray HeadFMF · Traditional | Medimop Medical Projects, Ltd. | 10/04/2012SE |
| K122373 | Neomed Oral/Enteral SyringeFMF · Special | Neomed, Inc. | 09/20/2012SE |
| K121476 | Infill Graft Delivery SystemFMF · Special | Pinnacle Spine Group, LLC | 08/29/2012SE |
| K113673 | Mysafety SyringeFMF · Traditional | Medicalchain Internartional Corporation | 08/03/2012SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2614-2026 Class II | SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604…A single lot of expired syringes were distributed due to a distribution system control failure. | Mentor Texas LP | 04/28/2026Open, Classified |
| Z-2396-2026 Class I | Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-1768-2026 Class II | Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe… | Cardinal Health 200, LLC | 02/27/2026Open, Classified |
| Z-1496-2026 Class II | 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk…During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated… | Becton Dickinson & Company | 01/27/2026Open, Classified |
| Z-1961-2025 Class I | MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line…Lack of sterility assurance. | Integra LifeSciences Corp. (NeuroSciences) | 05/23/2025Open, Classified |
| Z-1960-2025 Class I | Extended Tip Applicator 8CM, Box of 1.Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance. | Integra LifeSciences Corp. (NeuroSciences) | 05/22/2025Open, Classified |
| Z-1959-2025 Class I | Extended Tip Applicator, 15 CM, Box of 5.Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance. | Integra LifeSciences Corp. (NeuroSciences) | 05/22/2025Open, Classified |
| Z-1958-2025 Class I | Extended Tip Applicator, 8CM, Box of 5.Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance. | Integra LifeSciences Corp. (NeuroSciences) | 05/22/2025Open, Classified |
| Z-1972-2025 Class II | BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20…Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes… | BD Switzerland Sarl | 05/12/2025Open, Classified |
| Z-1971-2025 Class II | BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010…Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes… | BD Switzerland Sarl | 05/12/2025Open, Classified |
| Z-1650-2025 Class II | InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA…Insulin pens may have been incorrectly assembled therefore users could experience the following: either the… | Medtronic MiniMed, Inc. | 03/04/2025Open, Classified |
| Z-3154-2024 Class II | General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number…The syringes that were inadvertently shipped from the Distribution Center. This product was on quarantine… | Cypress Medical Products LLC | 08/06/2024Open, Classified |
| Z-2940-2024 Class II | McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102-S60C -…Affected syringes lack FDA clearance. | Cypress Medical Products LLC | 07/24/2024Open, Classified |
| Z-2535-2024 Class III | NavaClick Syringe and Needle, Model Number LIN02Incorrect GTIN number on carton. | Lineage Biomedical, Inc | 07/12/2024Open, Classified |
| Z-3078-2024 Class II | Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low…Products in distribution were found by FDA to be to be substantially different from the current cleared… | Sol-Millennium Medical Inc. | 05/09/2024Open, Classified |
| Z-3077-2024 Class II | Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle…Products in distribution were found by FDA to be to be substantially different from the current cleared… | Sol-Millennium Medical Inc. | 05/09/2024Open, Classified |
| Z-3076-2024 Class II | Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model…Products in distribution were found by FDA to be to be substantially different from the current cleared… | Sol-Millennium Medical Inc. | 05/09/2024Open, Classified |
| Z-3075-2024 Class II | Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock…Products in distribution were found by FDA to be to be substantially different from the current cleared… | Sol-Millennium Medical Inc. | 05/09/2024Open, Classified |
| Z-3074-2024 Class II | Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle…Products in distribution were found by FDA to be to be substantially different from the current cleared… | Sol-Millennium Medical Inc. | 05/09/2024Open, Classified |
| Z-2039-2024 Class II | Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids…Quarantined product was inadvertently distributed | Mckesson Medical-Surgical Inc. Corporate… | 04/23/2024Completed |
| Z-1938-2024 Class II | MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020It has been identified that testing documentation does not support that the syringes can successfully… | MEDLINE INDUSTRIES, LP - Northfield | 04/22/2024Open, Classified |
| Z-1937-2024 Class II | MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010It has been identified that testing documentation does not support that the syringes can successfully… | MEDLINE INDUSTRIES, LP - Northfield | 04/22/2024Open, Classified |
| Z-1936-2024 Class II | Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2.…These syringes were identified to be affected by the FDA Safety Alert issued on March 19, 2024. Leaks… | MEDLINE INDUSTRIES, LP - Northfield | 04/17/2024Open, Classified |
| Z-3033-2024 Class II | Medline Convenience kits labeled as: 1) SYRINGE CNTRL 10ML RED L/L LP , Pack Number…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-2128-2024 Class II | Brand Name: MEDLINE Product Name: SYR 20ML/L PURPLE Model/Catalog Number: 91843 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Jiangsu Shenli Medical Production Co., Ltd. | 04/05/2024Open, Classified |
| Z-2127-2024 Class II | Brand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Model/Catalog Number: 91848…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Jiangsu Shenli Medical Production Co., Ltd. | 04/05/2024Open, Classified |
| Z-2126-2024 Class II | Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE HEP FLUSH Model/Catalog Number: 91862…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Jiangsu Shenli Medical Production Co., Ltd. | 04/05/2024Open, Classified |
| Z-2125-2024 Class II | Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE CONTRAST Model/Catalog Number: 91860…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Jiangsu Shenli Medical Production Co., Ltd. | 04/05/2024Open, Classified |
| Z-2124-2024 Class II | Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205S-M…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Jiangsu Shenli Medical Production Co., Ltd. | 04/05/2024Open, Classified |
| Z-2123-2024 Class II | Brand Name: GMAX Product Name: SYR 60ML/LL Blue syringe Model/Catalog Number: TS2260LB-M…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Jiangsu Shenli Medical Production Co., Ltd. | 04/05/2024Open, Classified |
| Z-2122-2024 Class II | Brand Name: GMAX Product Name: SYR 10ML/LL Blue syringe Model/Catalog Number: TS2210B-M…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Jiangsu Shenli Medical Production Co., Ltd. | 04/05/2024Open, Classified |
| Z-2121-2024 Class II | Brand Name: GMAX Product Name: SYR 10ML Control syringe Model/Catalog Number: TS3210L-M…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Jiangsu Shenli Medical Production Co., Ltd. | 04/05/2024Open, Classified |
| Z-2120-2024 Class II | Brand Name: GMAX Product Name: SYR 60ML/LS syringe Model/Catalog Number: TS2260S-M…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Jiangsu Shenli Medical Production Co., Ltd. | 04/05/2024Open, Classified |
| Z-2119-2024 Class II | Brand Name: GMAX Product Name: SYR 20ML/LS syringe Model/Catalog Number: TS2220S-M…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Jiangsu Shenli Medical Production Co., Ltd. | 04/05/2024Open, Classified |
| Z-2118-2024 Class II | Brand Name: GMAX Product Name: SYR 12ML/LS syringe Model/Catalog Number: TS2212S-M…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Jiangsu Shenli Medical Production Co., Ltd. | 04/05/2024Open, Classified |
| Z-2117-2024 Class II | Brand Name: GMAX Product Name: SYR 10ML/LS syringe Model/Catalog Number: TS2210S-M…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Jiangsu Shenli Medical Production Co., Ltd. | 04/05/2024Open, Classified |
| Z-2116-2024 Class II | Brand Name: GMAX Product Name: SYR 60ML/LL syringe Model/Catalog Number: TS2260L-M…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Jiangsu Shenli Medical Production Co., Ltd. | 04/05/2024Open, Classified |
| Z-2115-2024 Class II | Brand Name: GMAX Product Name: SYR 35ML/LL syringe Model/Catalog Number: TS2235L-M…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Jiangsu Shenli Medical Production Co., Ltd. | 04/05/2024Open, Classified |
| Z-2114-2024 Class II | Brand Name: GMAX Product Name: SYR 30ML/LL syringe Model/Catalog Number: TS2230L-M…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Jiangsu Shenli Medical Production Co., Ltd. | 04/05/2024Open, Classified |
| Z-2113-2024 Class II | Brand Name: GMAX Product Name: SYR 20ML/LL syringe Model/Catalog Number: TS2220L-M…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Jiangsu Shenli Medical Production Co., Ltd. | 04/05/2024Open, Classified |
| Z-2112-2024 Class II | Brand Name: GMAX Product Name: SYR 12ML/LL syringe Model/Catalog Number: TS2212L-M…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Jiangsu Shenli Medical Production Co., Ltd. | 04/05/2024Open, Classified |
| Z-2111-2024 Class II | Brand Name: GMAX Product Name: SYR 10ML/LL syringe Model/Catalog Number: TS2210L-M…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Jiangsu Shenli Medical Production Co., Ltd. | 04/05/2024Open, Classified |
| Z-2110-2024 Class II | Brand Name: GMAX Product Name: SYR 6ML/LL syringe Model/Catalog Number: TS2206L-M…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Jiangsu Shenli Medical Production Co., Ltd. | 04/05/2024Open, Classified |
| Z-2109-2024 Class II | Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205L-M…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Jiangsu Shenli Medical Production Co., Ltd. | 04/05/2024Open, Classified |
| Z-2108-2024 Class II | Brand Name: GMAX Product Name: SYR 3ML/LL syringe Model/Catalog Number: TS2203L-M…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Jiangsu Shenli Medical Production Co., Ltd. | 04/05/2024Open, Classified |
| Z-2107-2024 Class II | Brand Name: Wolf Medical Product Name: 60 mL (cc) Luer Lock STERILE LATEX FREE NON…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Jiangsu Shenli Medical Production Co., Ltd. | 04/05/2024Open, Classified |
| Z-2106-2024 Class II | Brand Name: Wolf Medical Product Name: 35 mL (cc) Luer Lock STERILE LATEX FREE NON…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Jiangsu Shenli Medical Production Co., Ltd. | 04/05/2024Open, Classified |
| Z-2105-2024 Class II | Brand Name: Wolf Medical Product Name: 20 mL (cc) Luer Lock STERILE LATEX FREE NON…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Jiangsu Shenli Medical Production Co., Ltd. | 04/05/2024Open, Classified |
| Z-2104-2024 Class II | Brand Name: Wolf Medical Product Name: 12 mL (cc) Luer Lock STERILE LATEX FREE NON…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Jiangsu Shenli Medical Production Co., Ltd. | 04/05/2024Open, Classified |
| Z-2103-2024 Class II | Brand Name: Wolf Medical Product Name: 6 mL (cc) Luer Lock STERILE LATEX FREE NON…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | Jiangsu Shenli Medical Production Co., Ltd. | 04/05/2024Open, Classified |