Data / FDA device clearances / Gastroenterology, Urology

Gastroenterology, Urology device clearances: 813

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

The full list. FDA gastroenterology, urology device clearances and approvals: 813 rows for $40.65, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 37 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 (contact, pathway, device name, applicant address, 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.

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

FDA made 813 device decisions in gastroenterology, urology (FDA review panel) from November 12, 2024 to October 30, 2026: 502 510(k) clearances and De Novo grants and 311 PMA approvals and supplements, for 301 applicants. The newest, P250025/S002 on October 30, 2026, is TorEx Lung Perfusion System; TorEx Lung Perfusate from Traferox Technologies, Inc..

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

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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.

813Decisions
502510(k) and De Novo
311PMA
October 30, 2026Latest decision

Newest decisions

The newest 100 of 813, 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	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	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	K263075	Strauss Surgical Cystoscope/Hysteroscope and Accessories Instruments	Strauss Surgical USA	Florida	Substantially Equivalent	510(k) traditional	FAJ	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	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	K263459	SWICS	Bloom Surgical, Inc.	Utah	Substantially Equivalent	510(k) traditional	GCJ	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 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	K263512	Luja female	Coloplast Corp.	Minnesota	Substantially Equivalent	510(k) special	EZD	accessdata.fda.gov
October 27, 2026	K262531	OnControl Powered Bone Access Systems;OnControl Bone Marrow Aspiration System;OnControl Bone Marrow Biopsy...	Teleflex Medical, LLC	North Carolina	Substantially Equivalent	510(k) traditional	KNW	accessdata.fda.gov
October 26, 2026	K260350	Cysto-Urethroscopes and accessories	Hangzhou Hawk Optical Electronic Instruments Co., Ltd.	China	Substantially Equivalent	510(k) traditional	FJL	accessdata.fda.gov
October 23, 2026	K261670	Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation...	Poly Medicure Limited	India	Substantially Equivalent	510(k) traditional	LJH	accessdata.fda.gov
October 20, 2026	K260708	Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection); Vein360 Reprocessed...	Vein 360	Ohio	Substantially Equivalent	510(k) traditional	FGB	accessdata.fda.gov
October 19, 2026	K261203	multiFiltratePRO System	Fresenius Medical Care Renal Therapies Group, LLC	Massachusetts	Substantially Equivalent	510(k) traditional	KDI	accessdata.fda.gov
October 16, 2026	P240033/S002	LungFX Device	Lung Bioengineering, Inc.	Maryland	Approved	PMA 180-day supplement	PHO	accessdata.fda.gov
October 16, 2026	P240033/S001	LungFX Device	Lung Bioengineering, Inc.	Maryland	Approved	PMA 180-day supplement	PHO	accessdata.fda.gov
October 14, 2026	P050027/S038	Photodynamic Diagnostic D-Light C System	KARL STORZ Endoscopy-America, Inc.	California	30-day notice accepted	PMA 30-day notice	OAY	accessdata.fda.gov
October 14, 2026	K262455	da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5...	Intuitive Surgical, Inc.	California	Substantially Equivalent	510(k) traditional	GCJ	accessdata.fda.gov
October 14, 2026	K262044	Mediclose Cartridge System	Health Value Creation B.V. (trading as Corporis Medical)	Netherlands	Substantially Equivalent	510(k) traditional	OCW	accessdata.fda.gov
October 9, 2026	P970004/S459	InterStim Therapy System, Verify Evaluation System	Medtronic Neuromodulation	Minnesota	30-day notice accepted	PMA 30-day notice	EZW	accessdata.fda.gov
October 9, 2026	P200035/S038	OrganOx metra® System	Organox Limited		Approved	PMA 180-day supplement	QQK	accessdata.fda.gov
October 9, 2026	P080025/S353	InterStim Therapy System, Verify Evaluation System	Medtronic Neuromodulation	Minnesota	30-day notice accepted	PMA 30-day notice	QON	accessdata.fda.gov
October 6, 2026	P970004/S457	InterStim Therapy System, Verify Evaluation System	Medtronic Neuromodulation	Minnesota	Approved	PMA real-time process supplement	EZW	accessdata.fda.gov
October 6, 2026	P080025/S351	lnterStim Therapy System, Verify Evaluation System	Medtronic Neuromodulation	Minnesota	Approved	PMA real-time process supplement	QON	accessdata.fda.gov
October 6, 2026	K261141	OpenFlo Urinary Catheter	Urolution Medical, Inc.	Minnesota	Substantially Equivalent	510(k) traditional	EZL	accessdata.fda.gov
October 2, 2026	P230019/S005	MediBeacon Transdermal GFR System	Medibeacon, Inc.	Missouri	Approved	PMA special supplement	SDK	accessdata.fda.gov
October 2, 2026	K261791	MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor	Steris	Ohio	Substantially Equivalent	510(k) traditional	FEB	accessdata.fda.gov
October 2, 2026	K261783	Plenity-V (MC0979 / GS110)	Gelesis SRL	Italy	Substantially Equivalent	510(k) traditional	QFQ	accessdata.fda.gov
October 2, 2026	K261741	Hemostatic Clip	Anrei Medical (Hz) Co., Ltd.	China	Substantially Equivalent	510(k) traditional	PKL	accessdata.fda.gov
October 2, 2026	K260487	stentFIX System Set (100.50n)	Ovesco Endoscopy AG	Germany	Substantially Equivalent	510(k) traditional	PKL	accessdata.fda.gov
September 30, 2026	K262621	Rapid Barostat Bag (RBB) Pump and Catheter System	Mui Scientific, Inc.	Canada	Substantially Equivalent	510(k) special	FFX	accessdata.fda.gov
September 30, 2026	K262038	danumed StomaMeter	Danumed Medizintechnik GmbH	Germany	Substantially Equivalent	510(k) traditional	KNT	accessdata.fda.gov
September 25, 2026	K254230	CapsoView (CVV); CapsoCloud (CLD)	CapsoVision, Inc.	California	Substantially Equivalent	510(k) traditional	QZF	accessdata.fda.gov
September 24, 2026	P250011/S006	ProVee System for BPH	Proverum, Ltd.		Approved	PMA special supplement	MER	accessdata.fda.gov
September 23, 2026	P250023/S002	Allurion Gastric Balloon System	Allurion Technologies, Inc.	Massachusetts	Approved	PMA 180-day supplement	LTI	accessdata.fda.gov
September 23, 2026	K262353	BTL-299-F	BTL Industries, Inc.	Massachusetts	Substantially Equivalent	510(k) traditional	KPI	accessdata.fda.gov
September 23, 2026	K261418	Liquick X-treme, Liquick X-treme Plus	Teleflex Medical	Ireland	Substantially Equivalent	510(k) traditional	EZD	accessdata.fda.gov
September 21, 2026	K262547	KARL STORZ TIPCAM1 Rubina	KALR STORZ SE & Co. KG	Germany	Substantially Equivalent	510(k) traditional	OWN	accessdata.fda.gov
September 21, 2026	K260512	Disposable Ureteral Access Sheath	Yangzhou Fartley Medical Instrument Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	FED	accessdata.fda.gov
September 18, 2026	K262262	Pathfinder Endoscope Overtube	Neptune Medical, Inc.	California	Substantially Equivalent	510(k) traditional	FED	accessdata.fda.gov
September 18, 2026	K254179	Drainage Catheter	Canyon Medical, Inc.	China	Substantially Equivalent	510(k) traditional	FGE	accessdata.fda.gov
September 17, 2026	K262913	Protégé EverFlex Self-expanding Peripheral Stent System	Medtronic, Inc.	Minnesota	Substantially Equivalent	510(k) special	FGE	accessdata.fda.gov
September 16, 2026	P180014/S014	XPS with Steen Solution Perfusate	Xvivo Perfusion, Inc.	Colorado	Approved	PMA real-time process supplement	PHO	accessdata.fda.gov
September 16, 2026	K261913	X°Port Heart Preservation System	Traferox Technologies, Inc.	Canada	Substantially Equivalent	510(k) traditional	MSB	accessdata.fda.gov
September 16, 2026	K261400	Ambu® aScope Gastro; Ambu® aScope Gastro Large	Ambu A/S	Denmark	Substantially Equivalent	510(k) traditional	FDS	accessdata.fda.gov
September 15, 2026	K261447	CVAC® Aspiration System	Calyxo, Inc.	California	Substantially Equivalent	510(k) traditional	FGB	accessdata.fda.gov
September 14, 2026	P970004/S458	InterStim Therapy System Verify Evaluation System	Medtronic Neuromodulation	Minnesota	30-day notice accepted	PMA 30-day notice	EZW	accessdata.fda.gov
September 14, 2026	P240011/S016	Altaviva	Medtronic Neuromodulation	Minnesota	30-day notice accepted	PMA 30-day notice	QPT	accessdata.fda.gov
September 14, 2026	P080025/S352	InterStim Therapy System, Verify Evaluation System	Medtronic Neuromodulation	Minnesota	30-day notice accepted	PMA 30-day notice	QON	accessdata.fda.gov
September 14, 2026	P000053/S142	AMS 800 Artificial Urinary Sphincter (AUS)	Boston Scientific Corp	Massachusetts	30-day notice accepted	PMA 30-day notice	EZY	accessdata.fda.gov
September 14, 2026	N970012/S212	AMS 700 Inflatable Penile Prosthesis (IPP)	Boston Scientific Corp	Massachusetts	30-day notice accepted	PMA 30-day notice	JCW	accessdata.fda.gov
September 14, 2026	K253481	colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)	Ovesco Endoscopy AG	Germany	Substantially Equivalent	510(k) traditional	PKL	accessdata.fda.gov
September 12, 2026	K260133	CADDIE	Odin Medical Limited	United Kingdom	Substantially Equivalent	510(k) special	QNP	accessdata.fda.gov
September 11, 2026	K262397	CuratOR EX2742	Eizo Corporation	Japan	Substantially Equivalent	510(k) traditional	GCJ	accessdata.fda.gov
September 11, 2026	K260410	Single Use Ureteral Access Sheath	Zhejiang Chuangxiang Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) special	FED	accessdata.fda.gov
September 10, 2026	K262079	4K Camera Head OLYMPUS CH-S700-08-LB	Olympus Medical Systems Corp.	Japan	Substantially Equivalent	510(k) traditional	FET	accessdata.fda.gov
September 10, 2026	K260110	danumed Extension Set for Gastrostomy Button	Danumed Medizintechnik GmbH	Germany	Substantially Equivalent	510(k) traditional	PIF	accessdata.fda.gov
September 10, 2026	K254111	Irrigation/Urology Sets	B.Braun Medical, Inc.	Pennsylvania	Substantially Equivalent	510(k) traditional	LJH	accessdata.fda.gov
September 9, 2026	P250023/S001	Allurion Gastric Balloon System	Allurion Technologies, Inc.	Massachusetts	Approved	PMA special supplement	LTI	accessdata.fda.gov
September 9, 2026	P200036/S012	eCoin Peripheral Neurostimulator	Boston Scientific Corporation	Massachusetts	30-day notice accepted	PMA 30-day notice	QPT	accessdata.fda.gov
September 9, 2026	K262488	Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)	Guangzhou Red Pine Medical Instrument Co., Ltd.	China	Substantially Equivalent	510(k) traditional	FGB	accessdata.fda.gov
September 9, 2026	K261470	QF10	E.A.M Benelux B.V	Netherlands	Substantially Equivalent	510(k) traditional	NHV	accessdata.fda.gov
September 9, 2026	K260997	SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01)	Endoclot Plus Co., Ltd.	China	Substantially Equivalent	510(k) traditional	PLL	accessdata.fda.gov
September 8, 2026	K261823	da Vinci Surgical System, Model IS5000	Intuitive Surgical, Inc.	California	Substantially Equivalent	510(k) traditional	NAY	accessdata.fda.gov
September 4, 2026	K262292	Gastric Alimetry	Alimetry , Ltd.	New Zealand	Substantially Equivalent	510(k) traditional	MYE	accessdata.fda.gov
September 4, 2026	K260756	TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)	Sentinel Medical Technologies,	Florida	Substantially Equivalent	510(k) traditional	EZL	accessdata.fda.gov
September 3, 2026	K262460	Rezum System	Boston Scientific	Massachusetts	Substantially Equivalent	510(k) traditional	KNS	accessdata.fda.gov
September 3, 2026	K260503	Triton 1 System	Neptune Medical, Inc.	California	Substantially Equivalent	510(k) traditional	FDF	accessdata.fda.gov
September 1, 2026	K260884	UNIDRIVE Select System	Karl Storz SE & CO. KG	Germany	Substantially Equivalent	510(k) traditional	GCJ	accessdata.fda.gov
August 28, 2026	K260517	Automatic Core Biopsy Instrument	Zhejiang Curaway Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	KNW	accessdata.fda.gov
August 27, 2026	K260856	Disposable Distal Attachment D-201-13404	Olympus Medical Systems Corporation	Japan	Substantially Equivalent	510(k) traditional	FDS	accessdata.fda.gov
August 27, 2026	K260824	Gastrointestinal Videoscope Olympus GIF-2T1500	Olympus Medical Systems Corporation	Japan	Substantially Equivalent	510(k) traditional	FDS	accessdata.fda.gov
August 26, 2026	K261153	LithoVue Elite Digital Flexible Ureteroscope System	Boston Scientific Corporation	Massachusetts	Substantially Equivalent	510(k) traditional	FGB	accessdata.fda.gov
August 26, 2026	K260972	OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor	Sony Corporation	Japan	Substantially Equivalent	510(k) traditional	GCJ	accessdata.fda.gov
August 26, 2026	K253715	Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm...	Maquet Critical Care AB	Sweden	Substantially Equivalent	510(k) traditional	PIF	accessdata.fda.gov
August 21, 2026	P240031/S005	Neuspera Sacral Neuromodulation (SNM) System	Neuspera Medical, Inc.	California	Approved	PMA real-time process supplement	EZW	accessdata.fda.gov
August 21, 2026	K261015	Solo Scope Colonoscope System	Gi View, Ltd.	Israel	Substantially Equivalent	510(k) traditional	FDF	accessdata.fda.gov
August 20, 2026	P250018	RefluxStop® Device and RefluxStop® Deployment Tool	Implantica CE Reflux , Ltd.		Approved	PMA original approval	LEI	accessdata.fda.gov
August 20, 2026	DEN250043	Qoramatic Automated Stool Management	Cm Technologies, Inc.	Texas	Unknown	De Novo	SJB	accessdata.fda.gov
August 19, 2026	K260799	Nipro Dry Acid Concentrate Mixer	Nipro Technical Solutions, Incoporated	Arizona	Substantially Equivalent	510(k) traditional	KPO	accessdata.fda.gov
August 14, 2026	P970004/S456	InterStim Therapy System, Verify Evaluation System	Medtronic Neuromodulation	Minnesota	30-day notice accepted	PMA 30-day notice	EZW	accessdata.fda.gov
August 14, 2026	P240011/S015	Altaviva	Medtronic Neuromodulation	Minnesota	30-day notice accepted	PMA 30-day notice	QPT	accessdata.fda.gov
August 14, 2026	P080025/S350	InterStim Therapy System, Verify Evaluation System	Medtronic Neuromodulation	Minnesota	30-day notice accepted	PMA 30-day notice	QON	accessdata.fda.gov
August 14, 2026	K262571	EnCor EnCompass Breast Biopsy and Tissue Removal System	Bard Peripheral Vascular, Inc.	Arizona	Substantially Equivalent	510(k) special	KNW	accessdata.fda.gov
August 14, 2026	K262552	Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)	Scivita Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) special	FGB	accessdata.fda.gov
August 14, 2026	K261890	52Fr ViSiGi LUX; 52Fr ViSiGi 3D®	Boehringer Laboratories, LLC	Pennsylvania	Substantially Equivalent	510(k) special	KNT	accessdata.fda.gov
August 13, 2026	P000006/S076	Titan Inflatable Penile Prosthesis	Coloplast Corp.	Minnesota	30-day notice accepted	PMA 30-day notice	FHW	accessdata.fda.gov
August 13, 2026	K261139	VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)	Freyja Healthcare, LLC	Massachusetts	Substantially Equivalent	510(k) traditional	GCJ	accessdata.fda.gov
August 12, 2026	K262792	Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)	Hologic, Inc.	Massachusetts	Substantially Equivalent	510(k) special	KNW	accessdata.fda.gov
August 10, 2026	K254069	Hemoclip (511 series, 543 series)	Hangzhou AGS MedTech Co., Ltd.	China	Substantially Equivalent	510(k) traditional	PKL	accessdata.fda.gov
August 10, 2026	K253468	Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A)	Nova Eye, Inc.	California	Substantially Equivalent	510(k) traditional	MPA	accessdata.fda.gov
August 8, 2026	P970004/S455	InterStim Therapy System, Verify Evaluation System	Medtronic Neuromodulation	Minnesota	30-day notice accepted	PMA 30-day notice	EZW	accessdata.fda.gov
August 7, 2026	P200035/S041	OrganOx metra System	Organox Limited		30-day notice accepted	PMA 30-day notice	QQK	accessdata.fda.gov
August 7, 2026	P190006/S113	Axonics Sacral Neuromodulation System	Boston Scientific Corporation	Massachusetts	Approved	PMA 180-day supplement	QON	accessdata.fda.gov
August 7, 2026	P180046/S113	Axonics Sacral Neuromodulation System	Boston Scientific Corporation	Massachusetts	Approved	PMA 180-day supplement	EZW	accessdata.fda.gov
August 7, 2026	K260567	EW10-EC02 Endoscopy Support Program	Fujifilm Corporation	Japan	Substantially Equivalent	510(k) special	QNP	accessdata.fda.gov
August 7, 2026	K253702	Intuitive Endoluminal Gastrointestinal System (IG1000)	Intuitive Surgical, Inc.	California	Substantially Equivalent	510(k) traditional	FDS	accessdata.fda.gov
August 7, 2026	K253505	Zamenix P	Roen Surgical, Inc.	South Korea	Substantially Equivalent	510(k) traditional	FGB	accessdata.fda.gov
August 6, 2026	K253469	Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus Safety Fistula Cannula...	Mozarc Medical Us, LLC	Massachusetts	Substantially Equivalent	510(k) traditional	FIE	accessdata.fda.gov

Applicants with the most decisions

Applicant	Decisions	Latest
Medtronic Neuromodulation	119	October 29, 2026
Boston Scientific Corporation	71	September 9, 2026
Intuitive Surgical, Inc.	30	October 30, 2026
Organox Limited	23	October 9, 2026
Olympus Medical Systems Corporation	16	August 27, 2026
Fresenius Medical Care Renal Therapies Group, LLC	15	October 19, 2026
Coloplast Corp.	14	October 28, 2026
Boston Scientific Corp	14	September 14, 2026
Olympus Medical Systems Corp.	12	September 10, 2026
Karl Storz SE & CO. KG	11	September 1, 2026
TransMedics, Inc.	10	October 28, 2026
Fujifilm Corporation	8	August 7, 2026
Merz North America, Inc.	8	June 26, 2026
Traferox Technologies, Inc.	7	October 30, 2026
Proverum, Ltd.	6	September 24, 2026
Sequana Medical NV	6	May 5, 2026
KARL STORZ Endoscopy-America, Inc.	5	October 14, 2026
Medibeacon, Inc.	5	October 2, 2026
Neuspera Medical, Inc.	5	August 21, 2026
Hangzhou AGS MedTech Co., Ltd.	5	August 10, 2026

By decision type

Decision type	Decisions	Latest
510(k) traditional	436	October 30, 2026
PMA 30-day notice	190	October 29, 2026
510(k) special	62	October 30, 2026
PMA 180-day supplement	50	October 30, 2026
PMA real-time process supplement	35	October 6, 2026
PMA 135-day supplement	15	March 9, 2026
PMA special supplement	11	October 2, 2026
PMA original approval	10	August 20, 2026
De Novo	4	August 20, 2026

By state or country

State or country	Decisions	Latest
Minnesota	156	October 29, 2026
Massachusetts	134	October 28, 2026
China	101	October 29, 2026
California	78	October 30, 2026
Japan	43	September 11, 2026
Germany	22	October 2, 2026
South Korea	17	August 7, 2026
Florida	16	October 30, 2026
Illinois	16	July 15, 2026
United Kingdom	11	September 12, 2026
Israel	11	August 21, 2026
Pennsylvania	10	September 10, 2026
Ohio	9	October 20, 2026
Canada	9	September 30, 2026
Sweden	8	August 26, 2026
Texas	8	August 20, 2026
Wisconsin	8	June 26, 2026
New York	8	June 16, 2026
Arizona	7	August 19, 2026
Taiwan	7	June 10, 2026
North Carolina	6	October 27, 2026
Maryland	6	October 16, 2026
Georgia	6	July 10, 2026
Missouri	5	October 2, 2026
Ireland	5	September 23, 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.