Hematology devices

FDA product codes reviewed by the Hematology panel, with 510(k) clearances and recalls.

Recent 510(k) clearances

510(k)	Device	Applicant	Decision
K262151	SpaceOAR Flex SystemOVB · Traditional	Boston Scientific Corporation	09/11/2026SE
K261305	Micsi-PetKPS · Traditional	Microstructure Imaging, Inc.	09/11/2026SE
K254072	BoneVueKGI · Traditional	Curvebeam AI / Curvebeam, LLC	09/11/2026SE
K261795	Quicktome Software SuiteQIH · Traditional	Omniscient Neurotechnology Pty, Ltd.	09/10/2026SE
K260879	4DMQIH · Traditional	Invia, LLC	09/10/2026SE
K252486	ChestView US (1.1)MYN · Traditional	Gleamer	09/09/2026SE
K251417	ReVISION 2QIH · Traditional	Argus Cognitive, Inc.	09/09/2026SE
K260227	EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS…KPR · Traditional	DRTECH Corporation	09/08/2026SE
K262060	3D-RD-SLLZ · Traditional	Radiopharmaceutical Imaging & Dosimetry, LLC	09/04/2026SE
K260525	NextMR SpineQIH · Traditional	MRI2CT, Inc.	09/04/2026SE
K253836	FCT iStream Phase 2JAK · Traditional	Fujifilm Corporation	09/04/2026SE
K261313	Vivid Explorer/Vivid Advanced/Vivid FocusIYN · Traditional	GE Medical Systems Ultrasound and Primary Care…	09/02/2026SE
K254090	I-View®MUE · Traditional	Hologic, Inc.	09/02/2026SE
K262783	RadiForce MX247WPGY · Abbreviated	Eizo Corporation	09/01/2026SE
K260758	MAGNETOM Free.Max; MAGNETOM Free.StarLNH · Traditional	Siemens Shenzhen Magnetic Resonance , Ltd.	09/01/2026SE
K261718	EZFluence (RADEZ V2)IYE · Traditional	Radformation, Inc.	08/31/2026SE
K260488	MULTIX Impact; MULTIX Impact CKPR · Traditional	Siemens Medical Solutions USA, Inc.	08/31/2026SE
K261378	Rayvolve AZchestQBS · Traditional	AZmed	08/28/2026SE
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
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
K261595	Ceevra Reveal 4QIH · Traditional	Ceevra, Inc.	08/25/2026SE
K254027	Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…IYN · Traditional	Sonoscape Medical Corp.	08/24/2026SE
K262127	DS Core CBCT AnatomyQIH · Traditional	Dentsply Sirona	08/21/2026SE
K260584	BoneMRIQIH · Traditional	Mriguidance B.V.	08/21/2026SE
K253726	uAngio AVIVA CXOWB · Traditional	Shanghai United Imaging Healthcare Co., Ltd.	08/21/2026SE
K262622	Swoop® Portable MR Imaging® SystemLNH · Special	Hyperfine, Inc.	08/19/2026SE
K261413	Extron 3;EXTRON 6OWB · Traditional	DRTECH Corporation	08/19/2026SE
K261641	Lower Limb AI (LLAI)QIH · Traditional	AI Planning Logic, Inc.	08/18/2026SE

Product codes

Code	Device	Class	510(k)s	Recalls
DXN	System, Measurement, Blood-Pressure, Non-Invasive	2	1,225	27
DQY	Catheter, Percutaneous	2	895	456
DQX	Wire, Guide, Catheter	2	767	241
DQA	Oximeter	2	726	116
DYB	Introducer, Catheter	2	706	337
DPS	Electrocardiograph	2	576	53
DQO	Catheter, Intravascular, Diagnostic	2	501	254
DTB	Permanent Pacemaker Electrode	3	487	8
DXY	Implantable Pacemaker Pulse-Generator	3	461	17
DQK	Computer, Diagnostic, Programmable	2	437	117
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	2	430	279
LIT	Catheter, Angioplasty, Peripheral, Transluminal	2	403	29
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	2	401	529
DSI	Detector And Alarm, Arrhythmia	2	398	75
JOW	Sleeve, Limb, Compressible	2	354	32
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	2	339	6
DRX	Electrode, Electrocardiograph	2	329	18
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	2	308	83
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	2	297	10
DTZ	Oxygenator, Cardiopulmonary Bypass	2	254	94
MKJ	Automated External Defibrillators (Non-Wearable)	3	228	295
DXT	Injector And Syringe, Angiographic	2	210	60
DXC	Clamp, Vascular	2	205	26
DXQ	Blood Pressure Cuff	2	199	12
DSH	Recorder, Magnetic Tape, Medical	2	195	0
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	2	192	12
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	2	188	85
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	2	185	21
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	2	177	8
KRA	Catheter, Continuous Flush	2	176	80
DTN	Reservoir, Blood, Cardiopulmonary Bypass	2	169	45
LDD	Dc-Defibrillator, Low-Energy, (Including Paddles)	2	166	23
DSP	System, Balloon, Intra-Aortic And Control	2	162	193
DWJ	System, Thermal Regulating	2	161	66
DQD	Stethoscope, Electronic	2	156	0
DRS	Transducer, Blood-Pressure, Extravascular	2	149	236
MCW	Catheter, Peripheral, Atherectomy	2	146	31
QEW	Peripheral Mechanical Thrombectomy With Aspiration	2	144	10
DPW	Flowmeter, Blood, Cardiovascular	2	138	32
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	2	137	59
KRD	Device, Vascular, For Promoting Embolization	2	132	17
LDF	Electrode, Pacemaker, Temporary	2	130	15
MSX	System, Network And Communication, Physiological Monitors	2	120	19
DSB	Plethysmograph, Impedance	2	115	2
NRY	Catheter, Thrombus Retriever	2	114	26
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	2	105	12
DRE	Dilator, Vessel, For Percutaneous Catheterization	2	105	32
DTD	Pacemaker Lead Adaptor	2	103	0
QJP	Catheter, Percutaneous, Neurovasculature	2	99	7
DYG	Catheter, Flow Directed	2	99	27
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	2	96	4
QEZ	Aspiration Thrombectomy Catheter	2	95	0
DTR	Heat-Exchanger, Cardiopulmonary Bypass	2	91	31
MJN	Catheter, Intravascular Occluding, Temporary	2	90	21
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	2	90	19
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	2	88	115
DSF	Recorder, Paper Chart	1	87	1
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	2	84	39
DRO	Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)	2	84	22
DTK	Filter, Intravascular, Cardiovascular	2	83	19
OBJ	Catheter, Ultrasound, Intravascular	2	80	23
MNW	Analyzer, Body Composition	2	79	0
DXK	Echocardiograph	2	78	0
DXJ	Display, Cathode-Ray Tube, Medical	2	78	19
DSK	Computer, Blood-Pressure	2	77	1
KRH	Ring, Annuloplasty	2	75	0
MUD	Oximeter, Tissue Saturation	2	74	7
DXE	Catheter, Embolectomy	2	74	48
JOP	Transducer, Ultrasonic	2	72	1
QEY	Mechanical Thrombolysis Catheter	2	71	4
DWS	Instruments, Surgical, Cardiovascular	1	71	19
NLH	Catheter, Recording, Electrode, Reprocessed	2	70	48
DTE	Pulse-Generator, Pacemaker, External	2	65	5
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	2	64	5
DXO	Transducer, Pressure, Catheter Tip	2	64	10
PDU	Catheter For Crossing Total Occlusions	2	58	7
MAV	Syringe, Balloon Inflation	2	58	23
JOM	Plethysmograph, Photoelectric, Pneumatic Or Hydraulic	2	53	0
DTQ	Console, Heart-Lung Machine, Cardiopulmonary Bypass	2	52	253
DRC	Trocar	2	51	11
DPT	Probe, Blood-Flow, Extravascular	2	48	23
DRY	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass	2	47	40
PNO	Catheter, Percutaneous, Cutting/Scoring	2	45	3
DRM	Compressor, Cardiac, External	2	45	12
MOF	Guide, Wire, Catheter, Neurovasculature	2	44	2
KRI	Accessory Equipment, Cardiopulmonary Bypass	1	42	8
DRA	Catheter, Steerable	2	42	10
KRB	Probe, Thermodilution	2	37	4
DWA	Control, Pump Speed, Cardiopulmonary Bypass	2	37	12
NTE	Temporary Carotid Catheter For Embolic Capture	2	36	30
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	2	34	10
MTD	Catheter, Intracardiac Mapping, High-Density Array	2	34	8
DXX	System, Catheter Control, Steerable	2	34	4
DTP	Defoamer, Cardiopulmonary Bypass	2	34	0
DRN	Device, Counter-Pulsating, External	2	34	1
MLO	Electrocardiograph, Ambulatory, With Analysis Algorithm	2	33	2
MMX	Device, Percutaneous Retrieval	2	32	1
OWQ	Reprocessed Intravascular Ultrasound Catheter	2	31	10
DWC	Controller, Temperature, Cardiopulmonary Bypass	2	30	52
DTC	Analyzer, Pacemaker Generator Function	2	30	0
LDE	Stethoscope, Manual	1	28	0
DRB	Stylet, Catheter	2	28	0
NLF	Oximeter, Reprocessed	2	27	3
MGZ	Valvulotome	2	27	6
DRQ	Amplifier And Signal Conditioner, Transducer Signal	2	27	1
NCX	System, Hypothermia, Intravenous, Cooling	2	26	31
KRG	Programmer, Pacemaker	3	25	8
DQR	Cannula, Catheter	2	25	9
KRJ	Filter, Prebypass, Cardiopulmonary Bypass	2	24	0
DRR	Amplifier And Signal Conditioner, Biopotential	2	24	0
MXC	Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)	2	23	5
IZQ	Injector, Contrast Medium, Automatic	2	23	3
DWZ	Device, Biopsy, Endomyocardial	2	23	0
NFA	Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection	2	22	0
QYX	Outpatient Cardiac Telemetry	2	21	0
OZT	Balloon Aortic Valvuloplasty	2	21	2
DYF	Prosthesis, Vascular Graft, Of Less Then 6mm Diameter	2	21	17
DXF	Catheter, Septostomy	2	21	10
DWE	Tubing, Pump, Cardiopulmonary Bypass	2	21	46
DWB	Pump, Blood, Cardiopulmonary Bypass, Roller Type	2	21	2
DWP	Dilator, Vessel, Surgical	2	20	1
DWM	Apparatus, Suction, Patient Care	2	19	3
DRL	Tester, Defibrillator	2	19	1
DQE	Catheter, Oximeter, Fiber-Optic	2	19	14
JOQ	Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)	2	18	1
DQC	Phonocardiograph	1	18	0
LIX	Aid, Cardiopulmonary Resuscitation	2	17	2
DTW	Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass	2	17	15
DWD	Suction Control, Intracardiac, Cardiopulmonary Bypass	2	15	0
PPN	Percutaneous Catheter, Ultrasound	2	14	1
MLD	Monitor, St Segment With Alarm	2	14	2
KRL	Detector, Bubble, Cardiopulmonary Bypass	2	14	4
DWX	Stripper, Artery, Intraluminal	2	14	0
KRE	Analyzer, Pacemaker Generator Function, Indirect	2	13	0
DXS	Gauge, Pressure, Coronary, Cardiopulmonary Bypass	2	13	5
QME	Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate	2	12	0
JOD	Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass	2	12	0
DTJ	Holder, Heart-Valve, Prosthesis	1	12	0
DQT	Occluder, Catheter Tip	2	12	3
PSQ	Intracardiac Patch Or Pledget, Biologically Derived	2	11	2
KRC	Tester, Electrode, Surface, Electrocardiographic	2	11	0
DPZ	Oximeter, Ear	2	11	11
OMR	Vessel Guard Or Cover	2	10	0
OBH	Monitor, Extracellular Fluid, Lymphedema, Extremity	2	10	1
DTX	Gas Control Unit, Cardiopulmonary Bypass	2	10	0
DTA	Tester, Pacemaker Electrode Function	2	10	0
OGZ	Catheter, Intravascular, Plaque Morphology Evaluation	2	9	1
MJJ	Cpb Check Valve, Retrograde Flow, In-Line	2	9	36
KRK	Manometer, Blood-Pressure, Venous	2	9	1
DTS	Sucker, Cardiotomy Return, Cardiopulmonary Bypass	2	9	11
DQI	Withdrawal/Infusion Pump	2	9	0
QNR	Blood Pump For Ecmo, Long-Term (> 6 Hours) Use	2	8	2
QDA	Electrocardiograph Software For Over-The-Counter Use	2	8	0
PLB	Multivariate Vital Signs Index	2	8	0
PLA	Esophageal Thermal Regulation And Gastric Suctioning Device	2	8	0
PJA	Coronary Vascular Physiologic Simulation Software	2	8	0
NAJ	Agents, Embolic, For Treatment Of Uterine Fibroids	2	8	1
DWQ	Stripper, Vein, External	2	8	2
DTY	Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass	2	8	2
DSS	Clip, Vascular	2	8	4
DRW	Adaptor, Lead Switching, Electrocardiograph	2	8	0
PPW	Adjunctive Cardiovascular Status Indicator	2	7	0
PNE	Reprocessed Catheter Introducer	2	7	0
DTI	Sizer, Heart-Valve, Prosthesis	1	7	2
OTD	Endovascular Suturing System	2	6	1
NZE	Hyperthermia Monitor	2	6	1
MAL	Graft, Vascular, Synthetic/Biologic Composite	2	6	49
DSJ	Alarm, Blood-Pressure	2	6	4
QYE	Reduced Ejection Fraction Machine Learning-Based Notification Software	2	5	0
QNL	Medium-Term Adjunctive Predictive Cardiovascular Indicator	2	5	0
PQK	Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access	2	5	1
OMZ	Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter	2	5	0
NVM	Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon	2	5	2
DXW	System, Phonocatheter, Intracavitary	2	5	0
DXR	Ballistocardiograph	2	5	0
DTG	Magnet, Test, Pacemaker	1	5	0
QUO	Adjunctive Heart Failure Status Indicator	2	4	0
QJZ	Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure	2	4	2
QDB	Photoplethysmograph Analysis Software For Over-The-Counter Use	2	4	0
QAQ	Adjunctive Predictive Cardiovascular Indicator	2	4	0
PZS	Dual Lumen Ecmo Cannula	2	4	0
OHA	Heart Valve, More Than Minimally Manipulated Allograft	U	4	4
NUI	Ultrasound, Infusion, System	2	4	0
NQH	Sensor, Pressure, Aneurysm, Implantable	2	4	0
MWS	Stabilizer, Heart	1	4	17
MOP	Rotator, Prosthetic Heart Valve	1	4	0
LHX	Trousers, Anti-Shock	2	4	1
DYC	Vectorcardiograph	2	4	0
DRJ	System, Signal Isolation	1	4	0
DRI	Monitor, Line Isolation	1	4	1
SDJ	Adjunctive Cardiac Amyloidosis Status Indicator	2	3	0
SAT	Pulmonary Hypertension Machine Learning-Based Notification Software	2	3	0
QQI	Interventional Cardiovascular Implant Simulation Software Device	2	3	0
QHW	Single Lumen Ecmo Cannula	2	3	0
QEX	Coronary Mechanical Thrombectomy With Aspiration	2	3	0
QAF	Impedance Plethysmograph, Cranial	2	3	0
PJB	Catheter Remote Control System	2	3	1
PAW	Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement	2	3	1
OCR	Lung Sound Monitor	2	3	0
OAC	Plethysmograph, Air Displacement For Body Composition Analysis	2	3	0
NQG	Stabilizer, Heart, Non-Compression, Reprocessed	1	3	0
NMF	Clamp, Vascular, Reprocessed	2	3	2
NLG	Catheter, Intracardiac Mapping, High-Density, Reprocessed	2	3	0
MPD	Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator	2	3	0
MAB	Marker, Cardiopulmonary Bypass (Vein Marker)	2	3	0
KFJ	Materials, Repair Or Replacement, Pacemaker	3	3	0
DXL	Injector, Indicator	2	3	0
DQF	Actuator, Syringe, Injector Type	2	3	0
DQB	Phlebograph, Impedance	2	3	0
BYS	Oxygenator, Long Term Support Greater Than 6 Hours	2	3	2
QYW	Hospital Cardiac Telemetry	2	2	0
QNV	Adjunctive Hemodynamic Indicator With Decision Point	2	2	0
QLZ	Septostomy Catheter, Reprocessed	2	2	0
QJB	Adjunct Monitor, Protein Calorie Malnutrition	2	2	0
QEK	Angiographic Coronary Vascular Physiologic Simulation Software	2	2	0
PUM	Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures	2	2	0
PST	Aortic Annuloplasty Ring	2	2	0
PMK	Cpr Aid Device Without Feedback	1	2	0
PFA	Non-Invasive Central Venous Manometer	2	2	0
OLK	Pulse Oximeter For Over-The-Counter Use	2	2	0
OED	Antimicrobial Blood Pressure Cuff	2	2	0
NMD	Oximeter, Tissue Saturation, Reprocessed	2	2	0
NHW	Electrode, Pacing And Cardioversion, Temporary, Epicardial	2	2	0
NDQ	System, Catheter Or Guidewire, Steerable (Magnetic)	2	2	0
MNJ	Valve, Pressure Relief, Cardiopulmonary Bypass	2	2	1
MLC	Monitor, St Segment	2	2	0
MFX	Vessel Guard Or Cover, To Facilitate Revision Surgeries	2	2	0
LXN	Probe, Test, Heart-Valve	1	2	0
LWZ	Tissue Graft Of Less Than 6mm	3	2	0
DXP	Transducer, Vessel Occlusion	2	2	0
DXM	Densitometer	2	2	0
DTF	Tools, Pacemaker Service	1	2	0
SHP	Cardiac Amyloidosis Machine Learning-Based Notification Software	2	1	0
SGO	Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures	2	1	0
SFR	Hypertension Machine Learning-Based Notification Software	2	1	0
SDY	Loss Of Pulse Notification Software	2	1	0
SBQ	Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software	2	1	0
SAR	Adjunctive Hemodynamic Indicator With Decision Point For Military Use	2	1	0
QYU	Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use	2	1	0
QXZ	Adjunctive Epicardial Vascular Physiologic Status Indicator	2	1	0
QXX	Coronary Artery Disease Machine Learning-Based Notification Software	2	1	0
QXU	Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation	2	1	0
QXO	Cardiovascular Machine Learning-Based Notification Software	2	1	0
QWF	Tubing, Long Term Support Greater Than 6 Hours	2	1	0
QVQ	Extravascular Support For An Arteriovenous Fistula For Vascular Access	2	1	0
QTF	Reprocessed Atherectomy Catheter	2	1	8
QMS	Adjunctive Open Loop Fluid Therapy Recommender	2	1	0
QJH	Reverse Central Venous Recanalization System	2	1	0
QFJ	Intravascular Bleed Monitor	2	1	1
QEM	Cerebral Oximeter	2	1	0
QBE	Cranial Sound Monitor	2	1	0
PPS	Sleeve, Head And Neck, Compressible	2	1	0
PNS	Short-Term Intravascular Filter Catheter	2	1	0
OMV	Ultrasonic Body Composition Analyzer	2	1	0
OMH	Pericardial Patch To Facilitate Revision Surgeries	2	1	0
OJQ	Cardiac Allograft Gene Expression Profiling Test System	2	1	0
OFC	Catheter Introducer Kit	2	1	4
OBI	Catheter, Pressure Monitoring, Cardiac	2	1	1
NSA	Over-The-Counter Automated External Defibrillator	3	1	2
NPP	Reprocessed Blood Pressure Cuff	2	1	0
NPG	Catheter, Infusion, Syringe	2	1	0
NMK	Trocar, Reprocessed	2	1	0
NLI	Catheter, Angiography, Reprocessed	2	1	1
NKU	Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed	2	1	1
MPE	Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker	2	1	0
MFY	Endothelial Cell Harvesting Kit	2	1	0
DST	Clip, Vena-Cava	2	1	0
DSM	Alarm, Leakage Current, Portable	1	1	0
DRK	Dc-Defibrillator, High Energy, (Including Paddles)	3	1	0
DQH	Cardiograph, Apex (Vibrocardiograph)	2	1	0
SIU	Predictive Indicator For Long-Term Cardiovascular Outcomes	2	0	0
SIK	Cardiac Hypertrophy Machine Learning-Based Notification Software	2	0	0
SIJ	Valvular Regurgitation Machine Learning-Based Notification Software	2	0	0
SII	Aortic Stenosis Machine Learning-Based Notification Software	2	0	0
SIF	Software Device System For Estimation Of Cardiac Pressures	2	0	0
SHR	Device For Open Surgical Explant Of Endovascular Prostheses	2	0	0
SEU	Peripheral Temporary And Retrievable Stent System	2	0	0
SEQ	Covered Stent Vascular Connector, Hemodialysis Access Circuit	3	0	0
SEG	Leadless Cardiac Resynchronization Therapy (Crt)	3	0	0
SDZ	Endovascular System For Treatment Of Ascending Aorta And Aortic Arch Lesions	3	0	0
SCZ	Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures	2	0	1
SBK	Artificial Chordae Tendineae Surgical Replacement System	2	0	0
QZU	Temporary Embolization Assist Device, Peripheral	2	0	0
QZK	Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions	3	0	0
QZI	Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	3	0	6
QYI	Ablation Catheter, Renal Denervation	3	0	2
QYF	Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)	2	0	0
QXY	Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature	2	0	0
QXV	Temperature Regulation Device For Esophageal Protection During Cardiac Ablation	2	0	0
QWN	Stent Graft, Infrapopliteal, Venous Arterialization	3	0	0
QWM	Stent Graft, Bypass, Superficial Femoral Artery	3	0	0
QWC	Pulmonary Stent	3	0	0
QWA	Cardiovascular Delivery Catheter System Positioning And Stabilization Device	1	0	0
QVG	Embolization Agent, Vascular	3	0	0
QSK	Hybrid Stent Graft, Thoracic Aortic Lesion Treatment	3	0	0
QRJ	Laser-Powered Inferior Vena Cava Filter Retrieval Catheter	2	0	0
QOK	Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate	2	0	0
QOH	Extracorporeal System For Carbon Dioxide Removal	2	0	0
QOD	Extracorporeal Circuit And Accessories For Long Term Respiratory Cariodpulmonary Failure	N	0	0
QOC	Temporary Non-Roller Type Left Or Right Heart Support Blood Pump	N	0	0
QOA	Ppg Sensor Wearable For Hypercoagulation Detection And Covid-19 Screening	N	0	0
QNZ	Powered Communication System For Emergency Use	N	0	0
QNY	Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring	N	0	0
QMW	Coronary Artery Disease Risk Indicator From Acoustic Heart Signals	2	0	0
QMG	Shockwave Intravascular Lithotripsy System	3	0	0
QLN	Extracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19	N	0	1
QLM	Intensive Care Unit, Respiratory Failure And Hemodynamic Instability Tool	N	0	0
QLL	Left Ventricular Ejection Fraction Screening Tool	N	0	0
QLJ	Patient Monitor With Independent Remote Display And Operation	N	0	0
QKJ	Stent, Central Venous	3	0	0
QIK	Organ Care System (Ocs) Heart System	3	0	0
QFV	Implantable Pulse Generator	3	0	1
QCT	Scaffold, Dissection Repair	3	0	1
QBI	Acute Coronary Syndrome Event Detector	3	0	1
QAN	Stent, Iliac Vein	3	0	9
QAB	Pacing System Analyzer	2	0	0
PYX	Temporary Non-Roller Type Right Heart Support Blood Pump	3	0	7
PUH	Analyzer, Body Composition, Exempt	2	0	0
PTN	Reservoir, Blood, Cardiopulmonary Bypass, Exempt	2	0	0
PTM	Syringe, Balloon Inflation, Exempt	2	0	7
PTL	Wire, Guide, Catheter, Exempt	2	0	0
PRL	Iliac Covered Stent, Arterial	3	0	6
PRC	Drug-Coated Peripheral Transluminal Angioplasty Catheter	3	0	1
PNY	Absorbable Coronary Drug-Eluting Stent	3	0	1
PNQ	Apical Closure Device	2	0	0
PNJ	Leadless Pacemaker	3	0	6
PNF	Aortic Stent	3	0	0
PMJ	Cpr Aid Feedback Device (No Software)	2	0	0
PKK	Stent Delivery System	N	0	0
PJQ	Agent, Occluding, Vascular, Permanent	3	0	2
PIZ	Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve	3	0	0
PGJ	Oximeter, Wellness	2	0	0
PFY	Low Patient Acuity Monitoring System	2	0	0
PFV	System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment	3	0	1
PCX	Artificial Chordae Tendinae Delivery System	N	0	0
PCW	Implantable Pulse Generator, Programmer And Battery Charger	N	0	0
PCK	Pediatric Ventricular Assist Device	f	0	0
PAP	Aortic Heart Valve, More Than Minimally Manipulated Allograft	f	0	0
PAL	Pulmonic Replacement Heart Valve	f	0	0
OZH	Transcatheter Septal Occluder (Ventricular)	3	0	0
OZG	Transcatheter Septal Occluder (Atrial)	3	0	0
OZD	Temporary Non-Roller Type Left Heart Support Blood Pump	3	0	47
OVJ	Pulse Generator, External Pacemaker, Dual Chamber	2	0	0
OSR	Pacemaker/Icd/Crt Non-Implanted Components	3	0	15
ORD	Optical Coherence Tomography, Intravascular Catheter	2	0	0
OOB	Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter	3	0	0
ONU	Drug-Eluting Peripheral Transluminal Angioplasty Catheter	3	0	1
OKR	Ventricular Bypass (Assist) Device	3	0	0
OJX	Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode	3	0	0
OJE	Right Ventricular Bypass (Assist) Device	f	0	0
OFN	Winged Intravenous Catheterization Kit	2	0	0
OFM	Phlebotomy Blood Collection Kit	2	0	3
OFL	Percutaneous Sheath Introducer Kit	2	0	5
OFK	Percutaneous Atrial Catheter Kit	2	0	2
OFJ	Lead Introducer Kit	2	0	0
OFI	Laser Blood Flow Kit	2	0	0
OFH	Digital Angiography Tray	2	0	0
OFG	Ct Biopsy Tray	2	0	25
OFF	Central Venous Catheter Tray	2	0	50
OFE	Central Venous Blood Pressure Kit	2	0	0
OFD	Catheter Introducer Kit	2	0	7
OFB	Catheter Guide Wire Kit	2	0	2
OFA	Cardiovascular Surgical Instruments Tray	1	0	21
OEZ	Cardiovascular Procedure Kit	2	0	225
OEX	Cardiovascular Catheter Sheath Introducer Kit	2	0	2
OEU	Cardiopulmonary Bypass Catheter Kit	2	0	3
OET	Cardioplegia Solution Administration Kit	2	0	0
OES	Cardiac Catheterization Kit	2	0	93
OER	Angioscopic Valvulotome Kit	2	0	0
OEQ	Angiography/Angioplasty Kit	2	0	89
ODT	Tissue Adhesive, Aortic Aneurysmorrhaphy	f	0	0
OCM	Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation	3	0	0
OCH	Oximeter, Infrared, Sporting, Aviation	2	0	0
OBD	Barrier, Adhesion, Cardiovascular	3	0	0
OBC	Occluder, Internal Vessel, Temporary	3	0	18
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	3	0	34
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	3	0	22
NXW	Scaffold, Infrapopliteal, Absorbable	3	0	0
NWX	Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring	3	0	3
NVZ	Pulse Generator, Permanent, Implantable	3	0	40
NVY	Permanent Defibrillator Electrodes	3	0	5
NVN	Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	3	0	0
NPW	Percutaneously Delivered Prostheses And Tricuspid Valves	3	0	1
NPV	Pulmonary Valve Prosthesis Percutaneously Delivered	f	0	2
NPU	Prosthesis, Mitral Valve, Percutaneously Delivered	3	0	0
NPT	Aortic Valve, Prosthesis, Percutaneously Delivered	3	0	33
NPS	Tricuspid Valve Repair Device, Percutaneously Delivered	3	0	0
NMM	Catheter, Angioplasty, Peripheral, Transluminal, Reprocessed	2	0	0
NMB	Catheter, Oximeter, Fiber Optic, Reprocessed	2	0	0
NLJ	Stripper, Vein, External, Reprocessed	2	0	0
NKW	Actuator, Syringe, For Injector, Reprocessed	2	0	0
NKT	Injector And Syringe, Angiographic, Reprocessed	2	0	0
NKS	Catheter, Steerable, Reprocessed	2	0	0
NKR	System, Catheter Control, Reprocessed	2	0	0
NKQ	Guidewire, Catheter, Reprocessed	2	0	1
NKP	Injector, Contrast Medium, Automatic, Reprocessed	2	0	0
NKO	System, Balloon, Intra-Aortic And Control, Reprocessed	3	0	0
NKM	Mitral Valve Repair Devices	3	0	6
NKE	Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	3	0	27
NIV	Coronary Covered Stent	f	0	0