Data / FDA device clearances

FDA device clearances: 11,118 since Nov 2024

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

The full list. FDA device clearances and approvals: 11,118 rows for $191.18, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 474 rows a month. The new rows come each week by email, $23.70 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 5 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, 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 11,118 device decisions on medical devices from November 11, 2024 to October 30, 2026: 6,528 510(k) clearances and De Novo grants and 4,590 PMA approvals and supplements, for 3,638 applicants. The newest, P960009/S548 on October 30, 2026, is Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense from Medtronic, Inc..

The request: Every new FDA 510(k) clearance for an orthopedic device, with the applicant, its address and the product code. $10 of credit on sign-up, no card.

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11,118Decisions
6,528510(k) and De Novo
4,590PMA
October 30, 2026Latest decision

Newest decisions

The newest 100 of 11,118, 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	P960009/S548	Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	MHY	accessdata.fda.gov
October 30, 2026	P860004/S465	SynchroMed Infusion System, Ascenda Intrathecal Catheters	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	LKK	accessdata.fda.gov
October 30, 2026	P840001/S636	Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces-Quad...	Medtronic Neuromodulation	Minnesota	30-day notice accepted	PMA 30-day notice	LGW	accessdata.fda.gov
October 30, 2026	P810031/S083	Healon EndoCoat PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD); Healon Duet PRO II Dual Pack...	Johnson & Johnson Surgical Vision, Inc.	California	Approved	PMA real-time process supplement	LZP	accessdata.fda.gov
October 30, 2026	P250025/S002	TorEx Lung Perfusion System; TorEx Lung Perfusate	Traferox Technologies, Inc.		Approved	PMA 180-day supplement	PHO	accessdata.fda.gov
October 30, 2026	P250025/S001	TorEx Lung Perfusion System; TorEx Lung Perfusate	Traferox Technologies, Inc.		Approved	PMA 180-day supplement	PHO	accessdata.fda.gov
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	P190018/S050	Clareon Vivity Pro Extended Vision IOLs	Alcon Laboratories, LLC	Texas	Approved	PMA 180-day supplement	POE	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	P150031/S102	Vercise Deep Brain Stimulation (DBS) Systems	Boston Scientific Corp	California	30-day notice accepted	PMA 30-day notice	NHL	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	P140009/S144	Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)	Abbott Medical	Texas	30-day notice accepted	PMA 30-day notice	MHY	accessdata.fda.gov
October 30, 2026	P140009/S142	Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) Charger	Abbott Medical	Texas	30-day notice accepted	PMA 30-day notice	MHY	accessdata.fda.gov
October 30, 2026	P010032/S266	Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)	Abbott Medical	Texas	30-day notice accepted	PMA 30-day notice	LGW	accessdata.fda.gov
October 30, 2026	P010032/S264	Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) Charger	Abbott Medical	Texas	30-day notice accepted	PMA 30-day notice	LGW	accessdata.fda.gov
October 30, 2026	K263860	Shining3D Clear Aligner System	Hangzhou SHINING3D Dental Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	NXC	accessdata.fda.gov
October 30, 2026	K263592	da Vinci Xi Surgical System (IS4000);da Vinci X Surgical System (IS4200)	Intuitive Surgical, Inc.	California	Substantially Equivalent	510(k) special	NAY	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	K263232	eplex RP3 Control M530; eplex RP3 Negative	Maine Molecular Quality Controls, Inc.	Maine	Substantially Equivalent	510(k) traditional	PMN	accessdata.fda.gov
October 30, 2026	K263109	EFAI NEUROSUITE CTA LVO ASSESSMENT SYSTEM (LVO-CTA-100)	Ever Fortune.Ai, Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	QAS	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	K263075	Strauss Surgical Cystoscope/Hysteroscope and Accessories Instruments	Strauss Surgical USA	Florida	Substantially Equivalent	510(k) traditional	FAJ	accessdata.fda.gov
October 30, 2026	K263063	B`orze Inc Laser Family (Sorren/Adonis)	Borze, Inc.	Idaho	Substantially Equivalent	510(k) traditional	GEX	accessdata.fda.gov
October 30, 2026	K262971	Xpert® Hemorrhagic Fever Panel	Cepheid	California	Substantially Equivalent	510(k) traditional	QVR	accessdata.fda.gov
October 30, 2026	K262938	cobas eplex respiratory pathogen panel 3	GenMark Diagnostics, Inc.	California	Substantially Equivalent	510(k) traditional	QOF	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	K262685	Zirconia Collective 4Y Dental Zirconia Blank	Zirconia Collective, Inc.	Colorado	Substantially Equivalent	510(k) traditional	EIH	accessdata.fda.gov
October 30, 2026	K262470	Dual-Channel TENS & EMS Muscle Stimulator (Models TS1111, TS4111)	Changsha Anxiang Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	NGX	accessdata.fda.gov
October 30, 2026	K262066	Pleiades Device	My123Baby Medical Limited Dba Boost Fertility	Germany	Substantially Equivalent	510(k) traditional	MQK	accessdata.fda.gov
October 30, 2026	K261886	VIVO (9002)	Catheter Precision, Inc.	South Carolina	Substantially Equivalent	510(k) special	DQK	accessdata.fda.gov
October 30, 2026	K261072	DS Core Detect	Dentsply Sirona, Inc.	Pennsylvania	Substantially Equivalent	510(k) traditional	MYN	accessdata.fda.gov
October 30, 2026	K260738	Safe AQ Easy Blood Glucose Monitoring System; Safe AQ Care Blood Glucose Monitoring System	Changsha Sinocare, Inc.	China	Substantially Equivalent	510(k) special	NBW	accessdata.fda.gov
October 30, 2026	K260648	PolySense	Itamar Medical , Ltd.	Israel	Substantially Equivalent	510(k) traditional	GWL	accessdata.fda.gov
October 30, 2026	K260575	AutoGel Pad (400-046,400-005)	Top-Rank Health Care Co., Ltd.	China	Substantially Equivalent	510(k) traditional	MUI	accessdata.fda.gov
October 30, 2026	K260360	AesyBite Active	Aesyra SA	Switzerland	Substantially Equivalent	510(k) traditional	HCC	accessdata.fda.gov
October 30, 2026	K260354	Foster Plus-22L (SNK/CE-F22)	Zhejiang Fomos Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	FLE	accessdata.fda.gov
October 30, 2026	K260306	RENASYS-G 15Fr Channel Drain Gauze Dressing Kit (66802257); RENASYS 15Fr Channel Drain Accessory Kit...	Smith & Nephew Medical, Ltd.	United Kingdom	Substantially Equivalent	510(k) traditional	OMP	accessdata.fda.gov
October 30, 2026	K260058	Kerecis Express (50250)	Kerecis Limited	Iceland	Substantially Equivalent	510(k) traditional	KGN	accessdata.fda.gov
October 30, 2026	K253095	ULSPIRA TS Nitric Oxide Therapy System	Airgas Therapeutics, LLC	Pennsylvania	Substantially Equivalent	510(k) traditional	MRN	accessdata.fda.gov
October 30, 2026	DEN250054	Virtuoso Endoscopy System	Virtuoso Surgical, Inc.	Tennessee	Unknown	De Novo	SJS	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	P970004/S460	InterStim Therapy System, Verify Evaluation System (SNS Urinary Neurostimulator 97800), (SNS Urinary...	Medtronic Neuromodulation	Minnesota	30-day notice accepted	PMA 30-day notice	EZW	accessdata.fda.gov
October 29, 2026	P960009/S547	Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (DBS Neurostimulator Implantable...	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	MHY	accessdata.fda.gov
October 29, 2026	P860004/S464	SynchroMed Infusion System, Ascenda Intrathecal Catheters TDD (Drug Delivery Infusion Pump 8667), TDD (Drug...	Medtronic, Inc.	Minnesota	30-day notice accepted	PMA 30-day notice	LKK	accessdata.fda.gov
October 29, 2026	P840001/S635	Master Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces...	Medtronic Neuromodulation	Minnesota	30-day notice accepted	PMA 30-day notice	LGW	accessdata.fda.gov
October 29, 2026	P240039/S004	SetPoint System	SetPoint Medical	California	30-day notice accepted	PMA 30-day notice	SFJ	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	P080025/S354	InterStim Therapy System, Verify Evaluation System (SNS Bowel Neurostimulator 97800), (SNS Bowel...	Medtronic Neuromodulation	Minnesota	30-day notice accepted	PMA 30-day notice	QON	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	K263648	Vitrea Advanced Visualization, Version 7.16	Canon Medical Informatics, Inc.	Minnesota	Substantially Equivalent	510(k) special	LLZ	accessdata.fda.gov
October 29, 2026	K263628	ELEOS Limb Salvage System with NanoCept® Technology (Proximal Tibia) (AM-25002200-C)	Onkos Surgical, Inc.	New Jersey	Substantially Equivalent	510(k) special	QZZ	accessdata.fda.gov
October 29, 2026	K263602	Arthrex Plates, Screws and Pins, and Washers	Arthrex, Inc.	Florida	Substantially Equivalent	510(k) special	HRS	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	K263582	KeriFlex® MCP and PIP Finger Joint Prostheses	Keri Medical SA	Switzerland	Substantially Equivalent	510(k) special	KYJ	accessdata.fda.gov
October 29, 2026	K263530	V-Pro maX 2 Low Temperature Sterilization System	Steris	Ohio	Substantially Equivalent	510(k) special	MLR	accessdata.fda.gov
October 29, 2026	K263459	SWICS	Bloom Surgical, Inc.	Utah	Substantially Equivalent	510(k) traditional	GCJ	accessdata.fda.gov
October 29, 2026	K263065	MicroPort Total Knee System	Suzhou Microport Orthorecon Co., Ltd.	China	Substantially Equivalent	510(k) traditional	JWH	accessdata.fda.gov
October 29, 2026	K262960	Cerclage Cabling System	Pioneer Surgical Technology, Inc. dba EXALTA Group	Michigan	Substantially Equivalent	510(k) traditional	JDQ	accessdata.fda.gov
October 29, 2026	K262839	Cleerly ISCHEMIA	Cleerly, Inc.	Colorado	Substantially Equivalent	510(k) special	QXZ	accessdata.fda.gov
October 29, 2026	K262756	Zirconia Dental Ceramics and Staining Solution	Fanen New Materials Technology (Suzhou) Co., Ltd.	China	Substantially Equivalent	510(k) traditional	EIH	accessdata.fda.gov
October 29, 2026	K262731	Virata Spinal Fixation System	SeaSpine Orthopedics Corporation	California	Substantially Equivalent	510(k) traditional	NKB	accessdata.fda.gov
October 29, 2026	K262574	Convoy Expandable Corpectomy System	SeaSpine Orthopedics Corporation	California	Substantially Equivalent	510(k) traditional	MQP	accessdata.fda.gov
October 29, 2026	K262572	Symmetrix PX Spinal System	Medtronic Sofamor Danek USA, Inc.	Tennessee	Substantially Equivalent	510(k) traditional	MAX	accessdata.fda.gov
October 29, 2026	K262570	TZ Medical Birthing Balloon Kit	TZ Medical	Oregon	Substantially Equivalent	510(k) traditional	PFJ	accessdata.fda.gov
October 29, 2026	K262437	Single-use Digital Flexible Ureteroscope (GY-UR6.3); Single-use Digital Flexible Ureteroscope (GY-UR6.3A)	Zhejiang Geyi Medical Instrument Co., Ltd.	China	Substantially Equivalent	510(k) traditional	FGB	accessdata.fda.gov
October 29, 2026	K262415	OSSIX Plus	Datum Dental, Ltd.	Israel	Substantially Equivalent	510(k) traditional	NPL	accessdata.fda.gov
October 29, 2026	K262318	Minder® System	Epi-Minder Pty, Ltd.	Australia	Substantially Equivalent	510(k) traditional	SEM	accessdata.fda.gov
October 29, 2026	K262125	Nenesupply Venus Handsfree Breast Pump (NBP001-HF)	Nenesupply Co., Ltd.	Taiwan	Substantially Equivalent	510(k) traditional	HGX	accessdata.fda.gov
October 29, 2026	K260975	Libertas Acetabular Liners (Acetabular Liner)	Maxx Orthopedics, Inc.	Pennsylvania	Substantially Equivalent	510(k) traditional	JDI	accessdata.fda.gov
October 29, 2026	K260427	Lumicare (ONE);Lumicare (ONE Lite);Lumicare (ONE+)	Lumicare Medtech Co., Ltd.	China	Substantially Equivalent	510(k) traditional	SCS	accessdata.fda.gov
October 29, 2026	K260356	EndoColibri	Koehrer Medical Engineering GmbH	Germany	Substantially Equivalent	510(k) traditional	NYL	accessdata.fda.gov
October 29, 2026	K260337	SEEG-Tx® System (STX-SYS-001)	Dixi Medical	France	Substantially Equivalent	510(k) traditional	GXD	accessdata.fda.gov
October 29, 2026	K253508	Powder Free Nitrite Examination Glove, Cobalt Blue. Violet Blue and White. Non-Sterile	Vietglove Corporation	Vietnam	Substantially Equivalent	510(k) traditional	LZA	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	P250051/S001	Juveena Hydrogel System	Rejoni, Inc.	Massachusetts	30-day notice accepted	PMA 30-day notice	MCN	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	P160013/S023	Organ Care System (OCS) Lung System	TransMedics, Inc.	Massachusetts	30-day notice accepted	PMA 30-day notice	QBA	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	P150004/S101	Dorsal Root Ganglion Stimulation (DRG) EPG	Abbott Medical	Texas	30-day notice accepted	PMA 30-day notice	PMP	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	P140009/S141	Deep Brain Stimulation (DBS) EPG	Abbott Medical	Texas	30-day notice accepted	PMA 30-day notice	MHY	accessdata.fda.gov
October 28, 2026	P010032/S262	Spinal Cord Stimulation (SCS) External Pulse Generator (EPG)	Abbott Medical	Texas	30-day notice accepted	PMA 30-day notice	LGW	accessdata.fda.gov
October 28, 2026	K263583	Tornier Humeral Reconstruction System (HRS) Tuberosity Body	Tornier, Inc.	Minnesota	Substantially Equivalent	510(k) special	KWS	accessdata.fda.gov
October 28, 2026	K263512	Luja female	Coloplast Corp.	Minnesota	Substantially Equivalent	510(k) special	EZD	accessdata.fda.gov
October 28, 2026	K263313	Red Light Therapy Hair Growth Cap (RB-009, RB-011, RB-012, RB-088, RB-089, RB-092)	Shenzhen Rainbow Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	OAP	accessdata.fda.gov
October 28, 2026	K263005	Electric wheelchair (LW01301A02/LW01301A02L/LW01301A02T)	Anhui Longway Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	ITI	accessdata.fda.gov
October 28, 2026	K262343	Dynavisc	Fziomed, Inc.	California	Substantially Equivalent	510(k) traditional	OWW	accessdata.fda.gov
October 28, 2026	K262242	Profoject Safe Push Button Blood Collection Sets	CMT Health PTE., Ltd.	Singapore	Substantially Equivalent	510(k) traditional	JKA	accessdata.fda.gov
October 28, 2026	K261676	uPMR Zenith	Shanghai United Imaging Healthcare Co., Ltd.	China	Substantially Equivalent	510(k) traditional	OUO	accessdata.fda.gov

By panel

Panel	Decisions	Latest
Cardiovascular	3,161	October 30, 2026
Orthopedic	1,061	October 29, 2026
General, Plastic Surgery	992	October 30, 2026
Radiology	968	October 30, 2026
Neurology	841	October 30, 2026
Gastroenterology, Urology	813	October 30, 2026
Dental	480	October 30, 2026
General Hospital	378	October 30, 2026
Ophthalmic	378	October 30, 2026
Microbiology	377	October 30, 2026
Anesthesiology	279	October 30, 2026
Physical Medicine	272	October 30, 2026
Obstetrics/Gynecology	223	October 30, 2026
Pathology	194	October 27, 2026
Clinical Chemistry	176	October 30, 2026
Unknown	158	October 30, 2026
Ear, Nose, Throat	147	October 15, 2026
Immunology	95	October 30, 2026
Hematology	42	October 27, 2026
Clinical Toxicology	42	September 10, 2026
Medical Genetics	41	October 27, 2026

By decision type

Decision type	Decisions	Latest
510(k) traditional	5,367	October 30, 2026
PMA 30-day notice	2,874	October 30, 2026
510(k) special	983	October 30, 2026
PMA 180-day supplement	721	October 30, 2026
PMA real-time process supplement	552	October 30, 2026
PMA 135-day supplement	176	October 30, 2026
PMA special supplement	123	October 30, 2026
PMA original approval	81	October 27, 2026
510(k) abbreviated	76	October 21, 2026
PMA panel track supplement	63	October 23, 2026
De Novo	59	October 30, 2026
De Novo (dual track)	43	October 27, 2026

By state

State	Decisions	Latest
California	2,105	October 30, 2026
Minnesota	1,513	October 30, 2026
Massachusetts	485	October 28, 2026
Texas	347	October 30, 2026
Florida	301	October 30, 2026
Illinois	225	October 29, 2026
Pennsylvania	213	October 30, 2026
Arizona	188	October 23, 2026
Indiana	184	October 27, 2026
Oregon	174	October 29, 2026
New Jersey	165	October 29, 2026
New York	159	October 30, 2026
Colorado	135	October 30, 2026
Wisconsin	129	October 2, 2026
Tennessee	109	October 30, 2026
Washington	107	October 29, 2026
Ohio	101	October 29, 2026
Utah	98	October 29, 2026
Georgia	94	October 28, 2026
North Carolina	87	October 27, 2026
Maryland	63	October 27, 2026
Connecticut	47	September 6, 2026
Missouri	43	October 16, 2026
Virginia	40	October 20, 2026
Delaware	36	October 21, 2026
Michigan	34	October 29, 2026
New Hampshire	21	October 15, 2026
South Carolina	14	October 30, 2026
Nevada	14	October 26, 2026
Rhode Island	14	September 28, 2026
Oklahoma	11	October 20, 2026
Alabama	10	August 5, 2026
Maine	9	October 30, 2026
Puerto Rico	7	September 17, 2026
Wyoming	6	October 19, 2026
Kansas	5	October 2, 2026
Montana	5	September 2, 2026
Nebraska	5	August 20, 2026
Mississippi	4	July 24, 2026
South Dakota	4	June 18, 2026
Louisiana	4	December 22, 2025
Idaho	3	October 30, 2026
Kentucky	3	August 31, 2026
North Dakota	3	May 12, 2026
Iowa	2	October 16, 2026
West Virginia	2	April 27, 2026
New Mexico	2	November 25, 2025
Arkansas	1	February 19, 2026

By country

Applicants outside the United States, from the 510(k) record; a PMA record prints a US address.

Country	Decisions	Latest
China	1,126	October 30, 2026
South Korea	336	October 21, 2026
Germany	223	October 30, 2026
Israel	164	October 30, 2026
France	154	October 29, 2026
Japan	153	October 16, 2026
Switzerland	126	October 30, 2026
Taiwan	125	October 30, 2026
United Kingdom	109	October 30, 2026
Canada	100	October 23, 2026
Italy	97	October 2, 2026
Netherlands	72	October 22, 2026
Australia	62	October 29, 2026
Ireland	55	September 23, 2026
Spain	54	October 16, 2026
Sweden	54	September 22, 2026
Denmark	41	September 30, 2026
Singapore	38	October 28, 2026
Brazil	36	October 22, 2026
India	30	October 23, 2026
Belgium	27	October 9, 2026
Austria	25	July 31, 2026
Malaysia	23	October 1, 2026
Finland	17	September 4, 2026
Turkey	13	September 17, 2026
New Zealand	12	September 4, 2026
Iceland	8	October 30, 2026
Vietnam	8	October 29, 2026
Portugal	8	March 12, 2026
Hong Kong	7	August 19, 2026
Thailand	7	July 25, 2026
Poland	7	June 2, 2026
Slovenia	5	September 19, 2026
Norway	5	March 20, 2026
Lithuania	4	October 7, 2026
Hungary	4	September 27, 2026
Slovakia	4	July 1, 2026
Mexico	4	May 12, 2026
El Salvador	3	January 14, 2026
South Africa	3	December 19, 2025
Argentina	3	August 4, 2025
Luxembourg	2	September 15, 2026
Colombia	2	July 6, 2026
Czechia	2	May 28, 2026
Bulgaria	2	April 1, 2026
Greece	2	January 13, 2026
Mauritius	2	December 18, 2025
United Arab Emirates	1	September 15, 2026
Samoa	1	August 26, 2026
Virgin Islands, British	1	February 20, 2026
Liechtenstein	1	June 5, 2025
Pakistan	1	May 16, 2025
Egypt	1	May 12, 2025
Croatia	1	May 5, 2025
Cayman Islands	1	April 9, 2025
Belarus	1	March 21, 2025
Chile	1	February 5, 2025
Latvia	1	December 21, 2024
Andorra	1	December 18, 2024

Applicants with the most decisions

Applicant	Decisions	Latest
Medtronic, Inc.	525	October 30, 2026
Abbott Medical	471	October 30, 2026
Medtronic Neuromodulation	177	October 30, 2026
Medtronic Cardiac Rhythm Disease Management	160	October 29, 2026
Boston Scientific Corp	158	October 30, 2026
Boston Scientific Corporation	150	October 13, 2026
Biotronik, Inc.	137	October 28, 2026
Edwards Lifesciences, LLC	135	October 28, 2026
Boston Scientific	89	October 3, 2026
W. L. Gore & Associates, Inc.	73	October 8, 2026
DiaSorin, Inc.	64	September 24, 2026
Medtronic Vascular, Inc.	63	October 30, 2026
Biosense Webster, Inc.	58	September 15, 2026
Merz North America, Inc.	52	October 21, 2026
Depuy, Inc.	46	October 27, 2026
Arthrex, Inc.	41	October 29, 2026
Biotronik AG	41	September 24, 2026
CooperVision, Inc.	41	September 2, 2026
Johnson & Johnson Surgical Vision, Inc.	40	October 30, 2026
Roche Molecular Systems, Inc.	39	October 27, 2026
Cordis US Corporation	38	October 15, 2026
Medtronic Minimed, Inc.	37	September 29, 2026
ETHICON, Inc.	37	August 27, 2026
Intuitive Surgical, Inc.	35	October 30, 2026
ZOLL Medical Corporation	35	October 16, 2026
Abbott Molecular, Inc.	34	September 2, 2026
Siemens Healthcare Diagnostics, Inc.	33	September 22, 2026
Endotronix, Inc.	30	October 29, 2026
Inspire Medical Systems	30	October 26, 2026
Siemens Medical Solutions USA, Inc.	30	September 25, 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.