Data / FDA device clearances / Cardiovascular

FDA Cardiovascular device clearances: 3,161 since Nov 2024

Name: FDA cardiovascular device clearances and approvals
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

The full list. FDA cardiovascular device clearances and approvals: 3,161 rows for $111.61, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 126 rows a month. The new rows come each week by email, $19 a month.

Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (pathway, device name, applicant address, contact, date received, device type and 6 more), which open on your screen as soon as the payment clears and come by email. The weekly rows run until you cancel, from the link in each delivery. The rows on this page are a sample.

For agents and scripts: this list is ordered at https://specstream.ai/data/fda-clearances/panel/cardiovascular, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 30, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).

FDA made 3,161 device decisions in cardiovascular (FDA review panel) from November 12, 2024 to October 30, 2026: 763 510(k) clearances and De Novo grants and 2,398 PMA approvals and supplements, for 513 applicants. The newest, P200026/S020 on October 30, 2026, is Abre Venous Self-expanding Stent System from Medtronic Vascular, Inc..

The request: Every new FDA clearance or approval of a cardiovascular device, with the applicant, its address and the product code. $10 of credit on sign-up, no card.

Get new clearances like these Watch a company

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

3,161Decisions
763510(k) and De Novo
2,398PMA
October 30, 2026Latest decision

Newest decisions

The newest 100 of 3,161, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

Decision date	Number	Device	Applicant	Location	Decision	Type	Product code	Source
October 30, 2026	P200026/S020	Abre Venous Self-expanding Stent System	Medtronic Vascular, Inc.	Minnesota	Approved	PMA special supplement	QAN	accessdata.fda.gov
October 30, 2026	P170038/S034	CentriMag Circulatory Support System	Abbott	California	30-day notice accepted	PMA 30-day notice	DSQ	accessdata.fda.gov
October 30, 2026	P160035/S054	EXCOR Pediatric Ventricular Assist Device	Berlin Heart, Inc.	Texas	Approved	PMA 135-day supplement	DSQ	accessdata.fda.gov
October 30, 2026	P150006/S009	CELT ACD VASCULAR CLOSURE DEVICE	Vasorum, Ltd.		Approved	PMA special supplement	MGB	accessdata.fda.gov
October 30, 2026	K263587	Arctic Sun Neonatal ArcticGel Pad	Medivance, Inc.	Colorado	Substantially Equivalent	510(k) special	DWJ	accessdata.fda.gov
October 30, 2026	K263076	AngioVac F1885	AngioDynamics, Inc.	New York	Substantially Equivalent	510(k) traditional	DWF	accessdata.fda.gov
October 30, 2026	K262816	EXG PulseLinQ Cables (EXGPL)	Cb Innovations, LLC	California	Substantially Equivalent	510(k) traditional	DSA	accessdata.fda.gov
October 30, 2026	K261886	VIVO (9002)	Catheter Precision, Inc.	South Carolina	Substantially Equivalent	510(k) special	DQK	accessdata.fda.gov
October 29, 2026	P980035/S849	Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Azure S DR MRI IPG; Azure S...	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	NVZ	accessdata.fda.gov
October 29, 2026	P980016/S967	Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD	Medtronic Cardiac Rhythm Disease Management	Minnesota	30-day notice accepted	PMA 30-day notice	LWS	accessdata.fda.gov
October 29, 2026	P230040/S030	Cordella Pulmonary Artery Sensor System	Endotronix, Inc.	Illinois	Approved	PMA 180-day supplement	MOM	accessdata.fda.gov
October 29, 2026	P190023/S033	Navitor Transcatheter Aortic Valve Implantation System	Abbott Medical	Minnesota	Approved	PMA 180-day supplement	NPT	accessdata.fda.gov
October 29, 2026	P160026/S076	LIFEPAK® 35 monitor/defibrillator	Physio-Control, Inc.	Washington	30-day notice accepted	PMA 30-day notice	MKJ	accessdata.fda.gov
October 29, 2026	P010031/S934	Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D	Medtronic Cardiac Rhythm Disease Management	Minnesota	30-day notice accepted	PMA 30-day notice	NIK	accessdata.fda.gov
October 29, 2026	P010015/S592	Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara...	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	LWP	accessdata.fda.gov
October 29, 2026	K263598	VasQ	Laminate Medical Technologies	Israel	Substantially Equivalent	510(k) special	QVQ	accessdata.fda.gov
October 29, 2026	K263596	DLP Coronary Ostial Cannulae	Medtronic, Inc.	Minnesota	Substantially Equivalent	510(k) special	DWF	accessdata.fda.gov
October 29, 2026	K262839	Cleerly ISCHEMIA	Cleerly, Inc.	Colorado	Substantially Equivalent	510(k) special	QXZ	accessdata.fda.gov
October 28, 2026	P950037/S300	Amvia Sky DR-T, Amvia Sky SR-T; Amvia Edge DR-T, Amvia Edge SR-T; Solvia Rise DR-T, Solvia Rise SR-T; Amvia...	Biotronik, Inc.	Oregon	30-day notice accepted	PMA 30-day notice	DXY	accessdata.fda.gov
October 28, 2026	P860057/S228	Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix® tissue process...	Edwards Lifesciences, LLC	California	30-day notice accepted	PMA 30-day notice	DYE	accessdata.fda.gov
October 28, 2026	P230013/S034	Edwards EVOQUE Tricuspid Valve Replacement System (9850EV)	Edwards Lifesciences, LLC	California	30-day notice accepted	PMA 30-day notice	NPW	accessdata.fda.gov
October 28, 2026	P200045/S025	RelayPro Thoracic Stent-Graft Delivery System	Bolton Medical, Inc.	Florida	30-day notice accepted	PMA 30-day notice	MIH	accessdata.fda.gov
October 28, 2026	P200015/S084	Edwards SAPIEN 3 Transcatheter Heart Valve (9600TFX)	Edwards Lifesciences, LLC	California	30-day notice accepted	PMA 30-day notice	NPV	accessdata.fda.gov
October 28, 2026	P160035/S061	EXCOR Pediatric VAD	Berlin Heart, Inc.	Texas	30-day notice accepted	PMA 30-day notice	DSQ	accessdata.fda.gov
October 28, 2026	P150048/S104	INSPIRIS RESILIA Aortic Valve (11500A), KONECT RESILIA Aortic Valve Conduit (AVC) (11060A), MITRIS RESILIA...	Edwards Lifesciences, LLC	California	30-day notice accepted	PMA 30-day notice	LWR	accessdata.fda.gov
October 28, 2026	P150036/S081	EDWARDS INTUITY Elite Valve System (8300AB)	Edwards Lifesciences, LLC	California	30-day notice accepted	PMA 30-day notice	LWR	accessdata.fda.gov
October 28, 2026	P140031/S210	Edwards SAPIEN 3 Transcatheter Heart Valve (9600TFX), Edwards SAPIEN 3 Ultra Transcatheter Heart Valve...	Edwards Lifesciences, LLC	California	30-day notice accepted	PMA 30-day notice	NPT	accessdata.fda.gov
October 28, 2026	K261628	LymphaTech Mobile 3D Measuring Tool	Lymphatech, Inc.	Georgia	Substantially Equivalent	510(k) traditional	OBH	accessdata.fda.gov
October 28, 2026	K260670	YUWELL® Electronic Blood Pressure Monitor	Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.	China	Substantially Equivalent	510(k) traditional	DXN	accessdata.fda.gov
October 27, 2026	P260019	Amplatzer Paraclose PVL Occluder	Abbott Medical	Minnesota	Approved	PMA original approval	SJT	accessdata.fda.gov
October 27, 2026	P240044/S007	Globe® Catheter and Globe® Pulsed Field System	Kardium, Inc.		Approved	PMA real-time process supplement	QZI	accessdata.fda.gov
October 27, 2026	P200015/S077	SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra C Adaptive Prestent	Edwards Lifesciences, LLC	California	Approved	PMA 180-day supplement	NPV	accessdata.fda.gov
October 27, 2026	K261714	FlowXL® System: FlowXL Flowmeter and compatible Flowprobes and Flowsensors	Transonic Systems, Inc.	New York	Substantially Equivalent	510(k) traditional	DPW	accessdata.fda.gov
October 27, 2026	K260586	Nimbl Pneumatic Compression System	Tactile Medical	Minnesota	Substantially Equivalent	510(k) traditional	JOW	accessdata.fda.gov
October 27, 2026	K254226	PulseAPI SmartWatch	PulseAI, Ltd.	United Kingdom	Substantially Equivalent	510(k) traditional	DQK	accessdata.fda.gov
October 26, 2026	P960043/S138	Perclose ProStyle Suture-Mediated Closure and Repair System	Abbott Vascular, Inc.	California	30-day notice accepted	PMA 30-day notice	MGB	accessdata.fda.gov
October 26, 2026	P170011/S064	Impella RP Flex with SmartAssist	Abiomed, Inc.	Massachusetts	30-day notice accepted	PMA 30-day notice	PYX	accessdata.fda.gov
October 26, 2026	K262864	FLOWRUNNER Aspiration System	Expanse Medical, Inc.	California	Substantially Equivalent	510(k) traditional	QEZ	accessdata.fda.gov
October 23, 2026	P980035/S848	Astra S DR MRI IPG (X3DR01); Astra S SR MRI IPG (X3SR01); Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG...	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	NVZ	accessdata.fda.gov
October 23, 2026	P250050/S001	Liverty TIPS Stent Graft	Bard Peripheral Vascular, Inc.	Arizona	30-day notice accepted	PMA 30-day notice	MIR	accessdata.fda.gov
October 23, 2026	P250003/S011	Embrace® Hydrogel Embolic System	Instylla, Inc.	Massachusetts	Approved	PMA special supplement	QVG	accessdata.fda.gov
October 23, 2026	P250003/S008	Embrace(TM) Hydrogel Embolic System	Instylla, Inc.	Massachusetts	Approved	PMA panel track supplement	QVG	accessdata.fda.gov
October 23, 2026	P240044/S008	Globe® Pulsed Field System; Globe Catheter	Kardium, Inc.		30-day notice accepted	PMA 30-day notice	QZI	accessdata.fda.gov
October 23, 2026	P240036/S007	OmniaSecure MRI SureScan Lead Model 3930M	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	NVY	accessdata.fda.gov
October 23, 2026	P220026/S019	Symplicity G3 Renal Denervation RF Generator	Medtronic, Inc.	California	30-day notice accepted	PMA 30-day notice	QYI	accessdata.fda.gov
October 23, 2026	P160035/S060	EXCOR Pediatric Ventricular Assist Device	Berlin Heart, Inc.	Texas	30-day notice accepted	PMA 30-day notice	DSQ	accessdata.fda.gov
October 23, 2026	P010015/S591	Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena...	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	LWP	accessdata.fda.gov
October 23, 2026	K263380	STAR Apollo Mapping System	Rhythm AI, Ltd.	United Kingdom	Substantially Equivalent	510(k) special	DQK	accessdata.fda.gov
October 23, 2026	K260640	Kinetic Software Library	Monebo Technologies, Inc.	Texas	Substantially Equivalent	510(k) traditional	DPS	accessdata.fda.gov
October 22, 2026	P980023/S153	Ilivia Neo 7 VRT DX, Intica Neo 7 VRT DX, Intica Neo 5 VRT DX, Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor...	Biotronik, Inc.	Oregon	30-day notice accepted	PMA 30-day notice	LWS	accessdata.fda.gov
October 22, 2026	P950037/S299	Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6...	Biotronik, Inc.	Oregon	30-day notice accepted	PMA 30-day notice	DXY	accessdata.fda.gov
October 22, 2026	P220003/S032	PASCAL Precision Transcatheter Valve Repair System	Edwards Lifesciences, LLC	California	Approved	PMA real-time process supplement	NKM	accessdata.fda.gov
October 22, 2026	P150048/S100	INSPIRIS RESILIA Aortic Valve; MITRIS RESILIA Mitral Valve	Edwards Lifesciences, LLC	California	Approved	PMA 180-day supplement	LWR	accessdata.fda.gov
October 22, 2026	P140031/S202	Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve	Edwards Lifesciences, LLC	California	Approved	PMA 180-day supplement	NPT	accessdata.fda.gov
October 22, 2026	P070008/S184	Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75...	Biotronik, Inc.	Oregon	30-day notice accepted	PMA 30-day notice	NKE	accessdata.fda.gov
October 22, 2026	P050023/S216	Ilivia 7 VRT DX, Intica 7 VRT DX, Intica 5 VRT DX, Ilivia 7 VRT, Intica 7 VRT, Intica 5 VRT, Inlexa 7 VRT...	Biotronik, Inc.	Oregon	30-day notice accepted	PMA 30-day notice	MRM	accessdata.fda.gov
October 22, 2026	P000009/S135	Ilivia Neo 7 DRT, Intica Neo 7 DRT, Intica Neo 5 DRT, Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T...	Biotronik, Inc.	Oregon	30-day notice accepted	PMA 30-day notice	MRM	accessdata.fda.gov
October 22, 2026	K260686	Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter	Zylox Medtech Co., Ltd.	China	Substantially Equivalent	510(k) traditional	PNO	accessdata.fda.gov
October 21, 2026	P900056/S229	ROTAPRO Rotational Atherectomy System	Boston Scientific Corp	Minnesota	30-day notice accepted	PMA 30-day notice	MCX	accessdata.fda.gov
October 21, 2026	P900056/S226	ROTAPRO Rotational Atherectomy Systems	Boston Scientific Corp	Minnesota	Approved	PMA real-time process supplement	MCX	accessdata.fda.gov
October 21, 2026	P250003/S010	Embrace(TM) Hydrogel Embolic System	Instylla, Inc.	Massachusetts	Approved	PMA special supplement	QVG	accessdata.fda.gov
October 21, 2026	P230013/S033	EVOQUE Tricuspid Valve Replacement System	Edwards Lifesciences, LLC	California	Approved	PMA real-time process supplement	NPW	accessdata.fda.gov
October 21, 2026	P150035/S042	AVEIR VR Real-World Evidence Study	Abbott Medical	California	Approved	PMA 180-day supplement	PNJ	accessdata.fda.gov
October 21, 2026	K262021	Toro 71 Aspiration Catheter; Toro Aspiration Tubing	Toro Neurovascular, Inc.	California	Substantially Equivalent	510(k) traditional	NRY	accessdata.fda.gov
October 21, 2026	K252736	Hemotag Analysis Software (HAS)	Aventusoft, LLC	Florida	Substantially Equivalent	510(k) traditional	DQD	accessdata.fda.gov
October 20, 2026	P900056/S228	ROTAPRO Rotational Atherectomy System	Boston Scientific Corp	Minnesota	30-day notice accepted	PMA 30-day notice	MCX	accessdata.fda.gov
October 20, 2026	P230040/S035	Cordella Pulmonary Artery Sensor System (CorPASS)	Endotronix, Inc.	Illinois	30-day notice accepted	PMA 30-day notice	MOM	accessdata.fda.gov
October 20, 2026	P220003/S029	PASCAL Precision Transcatheter Valve Repair System	Edwards Lifesciences, LLC	California	Approved	PMA panel track supplement	NPS	accessdata.fda.gov
October 19, 2026	P230013/S029	Edwards EVOQUE Tricuspid Valve Replacement System	Edwards Lifesciences, LLC	California	Approved	PMA 135-day supplement	NPW	accessdata.fda.gov
October 19, 2026	P160054/S136	HeartMate 3 Left Ventricular Assist System	Abbott Medical	California	30-day notice accepted	PMA 30-day notice	DSQ	accessdata.fda.gov
October 19, 2026	K262917	Reprocessed BRK Transseptal Needle	Innovative Health, LLC	Arizona	Substantially Equivalent	510(k) traditional	NMK	accessdata.fda.gov
October 16, 2026	P950037/S289	BIOexpress	Biotronik, Inc.	Oregon	Approved	PMA 180-day supplement	DXY	accessdata.fda.gov
October 16, 2026	P250015	PerQseal® Elite Vascular Closure Device	Vivasure Medical , Ltd.		Approved	PMA original approval	MGB	accessdata.fda.gov
October 16, 2026	P230040/S031	Cordelia Pulmonary Artery Pressure Sensor System (CorPASS)	Endotronix, Inc.	Illinois	Approved	PMA real-time process supplement	MOM	accessdata.fda.gov
October 16, 2026	P220021/S009	DETOUR System	Endologix, LLC	California	30-day notice accepted	PMA 30-day notice	QWM	accessdata.fda.gov
October 16, 2026	P200026/S019	Abre Venous Self-Expanding Stent System	Medtronic Vascular, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	QAN	accessdata.fda.gov
October 16, 2026	P160043/S096	Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems	Medtronic Vascular	California	30-day notice accepted	PMA 30-day notice	NIQ	accessdata.fda.gov
October 16, 2026	P160022/S056	ZOLL R Series Monitor/Defibrillator	ZOLL Medical Corporation	Massachusetts	30-day notice accepted	PMA 30-day notice	MKJ	accessdata.fda.gov
October 16, 2026	P160015/S029	AED 3 Defibrillator with Uni-Padz	ZOLL Medical Corporation	Massachusetts	Approved	PMA 180-day supplement	MKJ	accessdata.fda.gov
October 16, 2026	P110023/S069	EverFlex Self-Expanding Peripheral Stent System; EverFlex Self-Expanding Peripheral Stent with Entrust...	Medtronic Vascular, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	NIP	accessdata.fda.gov
October 16, 2026	P070008/S177	BIOexpress	Biotronik, Inc.	Oregon	Approved	PMA 180-day supplement	NKE	accessdata.fda.gov
October 16, 2026	P060001/S059	Protégé GPS Self-Expanding Peripheral Stent System; Protégé RX Self-Expanding Carotid Stent System	Medtronic Vascular, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	NIM	accessdata.fda.gov
October 16, 2026	P050023/S209	BIOexpress	Biotronik, Inc.	Oregon	Approved	PMA 180-day supplement	MRM	accessdata.fda.gov
October 16, 2026	P030045/S011	Visi-Pro balloon-Expandable peripheral stent system	Medtronic Vascular, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	NIO	accessdata.fda.gov
October 16, 2026	P030036/S162	MEDTRONIC SELECTSECURE LEAD MODEL 3830	Medtronic Cardiac Rhythm Disease Management	Minnesota	30-day notice accepted	PMA 30-day notice	NVN	accessdata.fda.gov
October 16, 2026	P000009/S128	BIOexpress	Biotronik, Inc.	Oregon	Approved	PMA 180-day supplement	MRM	accessdata.fda.gov
October 16, 2026	K263266	Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set	Route 92 Medical, Inc.	California	Substantially Equivalent	510(k) special	NRY	accessdata.fda.gov
October 16, 2026	K260801	Sensinel Cardiopulmonary Management (CPM) System	Analog Devices	Massachusetts	Substantially Equivalent	510(k) traditional	MWI	accessdata.fda.gov
October 16, 2026	K260168	Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)	Skycade Med Corporation	Texas	Substantially Equivalent	510(k) traditional	DQX	accessdata.fda.gov
October 15, 2026	P250022/S002	Volt PFA System	Abbott Medical	Minnesota	Approved	PMA 180-day supplement	QZI	accessdata.fda.gov
October 15, 2026	P140018/S050	VenaSeal Closure System	Medtronic Vascular, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	PJQ	accessdata.fda.gov
October 15, 2026	P120002/S036	S.M.A.R.T. and S.M.A.R.T. ® CONTROL® Vascular Stent Systems; S.M.A.R.T. RADIANZ Vascular Stent System	Cordis US Corporation	Florida	30-day notice accepted	PMA 30-day notice	NIP	accessdata.fda.gov
October 15, 2026	P020036/S061	S.M.A.R.T. ® CONTROL® Nitinol Stent System	Cordis US Corporation	Florida	30-day notice accepted	PMA 30-day notice	NIO	accessdata.fda.gov
October 15, 2026	N16837/S040	Artegraft Collagen Vascular Graft	LeMaitre Vascular, Inc.	Massachusetts	30-day notice accepted	PMA 30-day notice	LXA	accessdata.fda.gov
October 15, 2026	K262904	INDIGO® Aspiration System	Penumbra, Inc.	California	Substantially Equivalent	510(k) traditional	QEW	accessdata.fda.gov
October 15, 2026	K262674	Giranel Guiding Sheath Set	Kossel Medtech (Suzhou) Co., Ltd.	China	Substantially Equivalent	510(k) traditional	DYB	accessdata.fda.gov
October 15, 2026	K262447	The Circadia CX00 System (CX00)	Circadia Health, Inc.	California	Substantially Equivalent	510(k) traditional	DRT	accessdata.fda.gov
October 14, 2026	P230040/S034	Cordella Pulmonary Artery Sensor System (CorPASS)	Endotronix, Inc.	Illinois	30-day notice accepted	PMA 30-day notice	MOM	accessdata.fda.gov
October 14, 2026	P180036/S046	OPTIMIZER Smart and Smart Mini System	Impulse Dynamics (Usa), Inc.	New Jersey	30-day notice accepted	PMA 30-day notice	QFV	accessdata.fda.gov
October 14, 2026	P160035/S056	EXCOR Pediatric VAD	Berlin Heart, Inc.	Texas	Approved	PMA 135-day supplement	DSQ	accessdata.fda.gov

Applicants with the most decisions

Applicant	Decisions	Latest
Medtronic, Inc.	425	October 29, 2026
Abbott Medical	371	October 29, 2026
Medtronic Cardiac Rhythm Disease Management	160	October 29, 2026
Biotronik, Inc.	137	October 28, 2026
Edwards Lifesciences, LLC	134	October 28, 2026
Boston Scientific Corp	101	October 21, 2026
Boston Scientific	84	October 3, 2026
W. L. Gore & Associates, Inc.	73	October 8, 2026
Medtronic Vascular, Inc.	63	October 30, 2026
Boston Scientific Corporation	62	October 2, 2026
Biosense Webster, Inc.	58	September 15, 2026
Biotronik AG	41	September 24, 2026
Cordis US Corporation	38	October 15, 2026
ZOLL Medical Corporation	32	October 16, 2026
Endotronix, Inc.	30	October 29, 2026
Medtronic Vascular	28	October 16, 2026
Physio-Control, Inc.	27	October 29, 2026
Abiomed, Inc.	26	October 26, 2026
Abbott Vascular, Inc.	22	October 26, 2026
Bolton Medical, Inc.	21	October 28, 2026

By decision type

Decision type	Decisions	Latest
PMA 30-day notice	1,570	October 30, 2026
510(k) traditional	564	October 30, 2026
PMA 180-day supplement	333	October 29, 2026
PMA real-time process supplement	280	October 27, 2026
510(k) special	188	October 30, 2026
PMA 135-day supplement	104	October 30, 2026
PMA special supplement	69	October 30, 2026
PMA original approval	24	October 27, 2026
PMA panel track supplement	18	October 23, 2026
510(k) abbreviated	6	September 4, 2026
De Novo	5	September 29, 2026

By state or country

State or country	Decisions	Latest
Minnesota	1,045	October 30, 2026
California	868	October 30, 2026
Oregon	145	October 28, 2026
China	115	October 28, 2026
Arizona	112	October 23, 2026
Massachusetts	104	October 26, 2026
Florida	70	October 28, 2026
Illinois	48	October 29, 2026
Washington	47	October 29, 2026
Georgia	35	October 28, 2026
Utah	31	September 16, 2026
Texas	26	October 30, 2026
Ireland	26	August 14, 2026
Pennsylvania	25	October 6, 2026
Italy	22	October 1, 2026
Colorado	20	October 30, 2026
Germany	20	July 8, 2026
New York	18	October 30, 2026
Israel	17	October 29, 2026
Japan	17	September 3, 2026
Ohio	16	October 1, 2026
North Carolina	15	July 29, 2026
New Jersey	14	October 14, 2026
Canada	14	July 23, 2026
United Kingdom	11	October 27, 2026

Where FDA publishes these decisions

CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.