Data / FDA device clearances / Wisconsin

FDA device clearances in Wisconsin: 129 since Nov 2024

Name: FDA device clearances for applicants in Wisconsin
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

The full list. FDA device clearances for applicants in Wisconsin: 129 rows for $6.45, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 4 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 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/state/wisconsin, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 2, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).

FDA made 129 device decisions for applicants in Wisconsin from November 12, 2024 to October 2, 2026: 59 510(k) clearances and De Novo grants and 70 PMA approvals and supplements, for 28 applicants. The newest, K261933 on October 2, 2026, is Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 from GE Medical Systems Ultrasound and Primary care Diagnostics, LLC.

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

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129Decisions
59510(k) and De Novo
70PMA
October 2, 2026Latest decision

Newest decisions

The newest 100 of 129, 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 2, 2026	K261933	Voluson Expert 18; Voluson Expert 20; Voluson Expert 22	GE Medical Systems Ultrasound and Primary care Diagnostics, LLC	Wisconsin	Substantially Equivalent	510(k) traditional	IYN	accessdata.fda.gov
October 2, 2026	K261042	Lung Guidance	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC	Wisconsin	Substantially Equivalent	510(k) traditional	QJU	accessdata.fda.gov
September 18, 2026	K260008	Deterioration Index Version 2	Epic Systems Corporation	Wisconsin	Substantially Equivalent	510(k) traditional	QNL	accessdata.fda.gov
September 16, 2026	K261623	EchoPAC Software Only / EchoPAC Plug-in (v211)	GE Medical Systems Ultrasound and Primary Care Diagnostics	Wisconsin	Substantially Equivalent	510(k) traditional	QIH	accessdata.fda.gov
September 15, 2026	P250046	OncoMate® MSI Dx Analysis System	Promega Corporation	Wisconsin	Approved	PMA original approval	SFL	accessdata.fda.gov
September 2, 2026	K261313	Vivid Explorer/Vivid Advanced/Vivid Focus	GE Medical Systems Ultrasound and Primary Care Diagnostics	Wisconsin	Substantially Equivalent	510(k) traditional	IYN	accessdata.fda.gov
August 13, 2026	K253808	AIR Recon DL	GE Medical Systems	Wisconsin	Substantially Equivalent	510(k) traditional	LNH	accessdata.fda.gov
August 10, 2026	K254036	Novii+ Wireless Patch System	Datex Ohmeda, Inc.	Wisconsin	Substantially Equivalent	510(k) traditional	HGM	accessdata.fda.gov
August 7, 2026	K261668	Venue Go	GE Medical Systems Ultrasound and Primary care Diagnostics, LLC	Wisconsin	Substantially Equivalent	510(k) traditional	IYN	accessdata.fda.gov
August 3, 2026	P230043/S010	Cologuard Plus	Exact Sciences Corporation	Wisconsin	30-day notice accepted	PMA 30-day notice	PHP	accessdata.fda.gov
July 30, 2026	K261835	LOGIQ Focus	GE Medical Systems Ultrasound and Primary Care Diagnostics	Wisconsin	Substantially Equivalent	510(k) traditional	IYN	accessdata.fda.gov
July 28, 2026	K260326	Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)	Datex-Ohmeda, Inc.	Wisconsin	Substantially Equivalent	510(k) traditional	FMZ	accessdata.fda.gov
July 24, 2026	K253277	Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P	Ge Medical Systems Information Technologies, Inc.	Wisconsin	Substantially Equivalent	510(k) traditional	MHX	accessdata.fda.gov
July 22, 2026	K262075	Lapidus Screw Kit	Relja Innovations, LLC	Wisconsin	Substantially Equivalent	510(k) special	HWC	accessdata.fda.gov
June 26, 2026	P050052/S179	RADIESSE® Injectable Implant	Merz North America, Inc.	Wisconsin	30-day notice accepted	PMA 30-day notice	LMH	accessdata.fda.gov
June 26, 2026	P050037/S154	RADIESSE® Injectable Implant	Merz North America, Inc.	Wisconsin	30-day notice accepted	PMA 30-day notice	LMH	accessdata.fda.gov
June 26, 2026	P040047/S083	COAPTITE® Agent, Bulking, Injectable For Gastro-Urology Use	Merz North America, Inc.	Wisconsin	30-day notice accepted	PMA 30-day notice	LNM	accessdata.fda.gov
June 24, 2026	K253560	Enhanced Boundary for PCCT	Ge Medical Systems, LLC	Wisconsin	Substantially Equivalent	510(k) traditional	JAK	accessdata.fda.gov
June 9, 2026	P230043/S009	Cologuard Plus	Exact Sciences Corporation	Wisconsin	30-day notice accepted	PMA 30-day notice	PHP	accessdata.fda.gov
June 9, 2026	P130017/S070	Cologuard®	Exact Sciences Corporation	Wisconsin	30-day notice accepted	PMA 30-day notice	PHP	accessdata.fda.gov
June 5, 2026	K254086	EyeBOX SNAP	Oculogica, Inc.	Wisconsin	Substantially Equivalent	510(k) traditional	QEA	accessdata.fda.gov
June 3, 2026	K261840	BracePaste Prime Plus	American Orthodontics	Wisconsin	Substantially Equivalent	510(k) traditional	DYH	accessdata.fda.gov
June 2, 2026	P230043/S007	Cologuard Plus	Exact Sciences Corporation	Wisconsin	Approved	PMA real-time process supplement	PHP	accessdata.fda.gov
May 27, 2026	P230043/S006	Cologuard Plus	Exact Sciences Corporation	Wisconsin	Approved	PMA real-time process supplement	PHP	accessdata.fda.gov
May 27, 2026	P130017/S068	Cologuard®	Exact Sciences Corporation	Wisconsin	Approved	PMA real-time process supplement	PHP	accessdata.fda.gov
May 26, 2026	K260398	LOGIQ e	GE Medical Systems Ultrasound and Primary Care Diagnostics	Wisconsin	Substantially Equivalent	510(k) traditional	IYN	accessdata.fda.gov
May 14, 2026	P050052/S178	RADIESSE® Injectable Implant, RADIESSE® Hands	Merz North America, Inc.	Wisconsin	30-day notice accepted	PMA 30-day notice	LMH	accessdata.fda.gov
May 14, 2026	P050037/S153	RADIESSE® Injectable Implant	Merz North America, Inc.	Wisconsin	30-day notice accepted	PMA 30-day notice	LMH	accessdata.fda.gov
May 14, 2026	P040047/S082	COAPTITE® AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE	Merz North America, Inc.	Wisconsin	30-day notice accepted	PMA 30-day notice	LNM	accessdata.fda.gov
May 3, 2026	P090016/S067	Belotero Balance Dermal Filler; Belotero Balance (+) Lidocaine	Merz North America, Inc.	Wisconsin	Approved	PMA 180-day supplement	LMH	accessdata.fda.gov
April 23, 2026	K260947	0.55T 12Ch Breast Coil	Neocoil, LLC	Wisconsin	Substantially Equivalent	510(k) special	MOS	accessdata.fda.gov
April 22, 2026	P230043/S008	Cologuard Plus	Exact Sciences Corporation	Wisconsin	30-day notice accepted	PMA 30-day notice	PHP	accessdata.fda.gov
April 22, 2026	P130017/S069	Cologuard®	Exact Sciences Corporation	Wisconsin	30-day notice accepted	PMA 30-day notice	PHP	accessdata.fda.gov
April 22, 2026	P070004/S048	Sientra Silicone Gel Breast Implants	Tiger Aesthetics Medical, LLC	Wisconsin	30-day notice accepted	PMA 30-day notice	FTR	accessdata.fda.gov
April 20, 2026	K252718	Lunar Astra	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC	Wisconsin	Substantially Equivalent	510(k) traditional	KGI	accessdata.fda.gov
April 17, 2026	DEN250033	XplantR Explant Tool	Hjarta Care, LLC	Wisconsin	Unknown	De Novo	SHR	accessdata.fda.gov
April 15, 2026	K253337	REGEN Bioactive Cement	Inter-Med, Inc.	Wisconsin	Substantially Equivalent	510(k) traditional	EMA	accessdata.fda.gov
April 14, 2026	K253502	Critical Care Suite with Enteric Tube Positioning AI Algorithm	Ge Medical Systems, LLC	Wisconsin	Substantially Equivalent	510(k) traditional	QIH	accessdata.fda.gov
March 31, 2026	P050052/S162	RADIESSE® Injectable Implant	Merz North America, Inc.	Wisconsin	Approved	PMA panel track supplement	LMH	accessdata.fda.gov
March 27, 2026	K254161	Automated Aortic Stenosis Software (AutoAS)	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC	Wisconsin	Substantially Equivalent	510(k) traditional	POK	accessdata.fda.gov
March 24, 2026	P050052/S177	P050052 RADIESSE® Injectable Implant; RADIESSE® Hands; RADIESSE® (+) Lidocaine; Jawline indication	Merz North America, Inc.	Wisconsin	30-day notice accepted	PMA 30-day notice	LMH	accessdata.fda.gov
March 24, 2026	P050052/S176	RADIESSE® Injectable Implant	Merz North America, Inc.	Wisconsin	30-day notice accepted	PMA 30-day notice	LMH	accessdata.fda.gov
March 24, 2026	P050037/S152	RADIESSE® Injectable Implant	Merz North America, Inc.	Wisconsin	30-day notice accepted	PMA 30-day notice	LMH	accessdata.fda.gov
March 24, 2026	P050037/S151	RADIESSE® Injectable Implant	Merz North America, Inc.	Wisconsin	30-day notice accepted	PMA 30-day notice	LMH	accessdata.fda.gov
March 24, 2026	K260673	LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro...	GE Medical Systems Ultrasound and Primary Care Diagnostics	Wisconsin	Substantially Equivalent	510(k) traditional	IYN	accessdata.fda.gov
March 20, 2026	K253520	Photonova Spectra, Photonova Spectra Select	Ge Medical Systems, LLC	Wisconsin	Substantially Equivalent	510(k) traditional	JAK	accessdata.fda.gov
March 18, 2026	P050052/S175	RADIESSE® Injectable Implant	Merz North America, Inc.	Wisconsin	30-day notice accepted	PMA 30-day notice	LMH	accessdata.fda.gov
March 18, 2026	P050037/S150	RADIESSE® Injectable Implant	Merz North America, Inc.	Wisconsin	30-day notice accepted	PMA 30-day notice	LMH	accessdata.fda.gov
March 18, 2026	P040047/S081	COAPTITE® Injectable Implant	Merz North America, Inc.	Wisconsin	30-day notice accepted	PMA 30-day notice	LNM	accessdata.fda.gov
March 13, 2026	P230043/S005	Cologuard Plus	Exact Sciences Corporation	Wisconsin	30-day notice accepted	PMA 30-day notice	PHP	accessdata.fda.gov
March 13, 2026	P130017/S067	Cologuard®	Exact Sciences Corporation	Wisconsin	30-day notice accepted	PMA 30-day notice	PHP	accessdata.fda.gov
February 9, 2026	P230043/S004	Cologuard Plus	Exact Sciences Corporation	Wisconsin	30-day notice accepted	PMA 30-day notice	PHP	accessdata.fda.gov
February 6, 2026	K253780	SIGNA Bolt	Ge Medical Systems, LLC	Wisconsin	Substantially Equivalent	510(k) traditional	LNH	accessdata.fda.gov
February 5, 2026	K253779	SIGNA Sprint Select	Ge Medical Systems, LLC	Wisconsin	Substantially Equivalent	510(k) traditional	LNH	accessdata.fda.gov
January 26, 2026	K251670	MAC 7 Resting ECG Analysis System	Ge Medical Systems Information Technologies, Inc.	Wisconsin	Substantially Equivalent	510(k) traditional	DPS	accessdata.fda.gov
January 13, 2026	P050052/S174	RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, Jawline indication	Merz North America, Inc.	Wisconsin	30-day notice accepted	PMA 30-day notice	LMH	accessdata.fda.gov
January 13, 2026	P050037/S149	RADIESSE® Injectable Implant	Merz North America, Inc.	Wisconsin	30-day notice accepted	PMA 30-day notice	LMH	accessdata.fda.gov
January 13, 2026	P040047/S080	COAPTITE	Merz North America, Inc.	Wisconsin	30-day notice accepted	PMA 30-day notice	LNM	accessdata.fda.gov
January 8, 2026	K253370	LOGIQ Totus	GE Medical Systems Ultrasound and Primary Care Diagnostics	Wisconsin	Substantially Equivalent	510(k) traditional	IYN	accessdata.fda.gov
January 7, 2026	K253366	LOGIQ Fortis	GE Medical Systems Ultrasound and Primary Care Diagnostics	Wisconsin	Substantially Equivalent	510(k) traditional	IYN	accessdata.fda.gov
January 6, 2026	P230043/S003	Stool DNA (sDNA) Test, Cologuard Plus	Exact Sciences Corporation	Wisconsin	30-day notice accepted	PMA 30-day notice	PHP	accessdata.fda.gov
December 30, 2025	K250168	Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer	Lucas Lifecare	Wisconsin	Substantially Equivalent	510(k) traditional	FLE	accessdata.fda.gov
December 23, 2025	K252379	AIR Recon DL	Ge Medical Systems, LLC	Wisconsin	Substantially Equivalent	510(k) traditional	LNH	accessdata.fda.gov
December 12, 2025	P050052/S173	RADIESSE INJECTABLE IMPLANT	Merz North America, Inc.	Wisconsin	30-day notice accepted	PMA 30-day notice	LMH	accessdata.fda.gov
December 12, 2025	P050037/S148	RADIESSE 1.3CC AND 0.3CC	Merz North America, Inc.	Wisconsin	30-day notice accepted	PMA 30-day notice	LMH	accessdata.fda.gov
December 12, 2025	P040047/S079	COAPTITE	Merz North America, Inc.	Wisconsin	30-day notice accepted	PMA 30-day notice	LNM	accessdata.fda.gov
November 24, 2025	P130017/S066	Cologuard®	Exact Sciences Corporation	Wisconsin	Approved	PMA real-time process supplement	PHP	accessdata.fda.gov
November 24, 2025	K252328	Voluson Expert 18; Voluson Expert 20; Voluson Expert 22	GE Medical Systems Ultrasound and Primary Care Diagnostics	Wisconsin	Substantially Equivalent	510(k) traditional	IYN	accessdata.fda.gov
November 21, 2025	P130020/S005	Senographe Pristina 3D	GE Healthcare	Wisconsin	Approved	PMA 180-day supplement	OTE	accessdata.fda.gov
November 20, 2025	P070004/S045	Sientra Silicone Gel Breast Implants	Tiger Aesthetics Medical, LLC	Wisconsin	Approved	PMA 135-day supplement	FTR	accessdata.fda.gov
November 5, 2025	P240026	OncoMate® MSI Dx Analysis System	Promega Corporation	Wisconsin	Approved	PMA original approval	SFL	accessdata.fda.gov
October 29, 2025	K251985	LOGIQ E10	GE Medical Systems Ultrasound and Primary Care Diagnostics	Wisconsin	Substantially Equivalent	510(k) traditional	IYN	accessdata.fda.gov
October 29, 2025	K251963	LOGIQ E10s	GE Medical Systems Ultrasound and Primary Care Diagnostics	Wisconsin	Substantially Equivalent	510(k) traditional	IYN	accessdata.fda.gov
October 24, 2025	P090016/S068	Belotero Balance (+) Lidocaine Dermal Filler	Merz North America, Inc.	Wisconsin	30-day notice accepted	PMA 30-day notice	LMH	accessdata.fda.gov
October 22, 2025	K251663	Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)	Datex-Ohmeda, Inc.	Wisconsin	Substantially Equivalent	510(k) traditional	FMZ	accessdata.fda.gov
October 10, 2025	P090016/S066	Belotero Balance (+) Lidocaine Dermal Filler	Merz North America, Inc.	Wisconsin	Approved	PMA 180-day supplement	LMH	accessdata.fda.gov
October 7, 2025	P130017/S065	Cologuard®	Exact Sciences Corporation	Wisconsin	30-day notice accepted	PMA 30-day notice	PHP	accessdata.fda.gov
September 11, 2025	K251399	SIGNA Sprint	Ge Medical Systems, LLC	Wisconsin	Substantially Equivalent	510(k) traditional	LNH	accessdata.fda.gov
August 27, 2025	P040047/S078	COAPTITE Injectable Implant	Merz North America, Inc.	Wisconsin	Approved	PMA special supplement	LNM	accessdata.fda.gov
August 1, 2025	K250941	Revolution Vibe	Ge Medical Systems, LLC	Wisconsin	Substantially Equivalent	510(k) traditional	JAK	accessdata.fda.gov
July 25, 2025	K251322	Venue; Venue Go; Venue Fit; Venue Sprint	GE Medical Systems Ultrasound and Primary Care Diagnostics	Wisconsin	Substantially Equivalent	510(k) traditional	IYN	accessdata.fda.gov
July 25, 2025	K250970	Marie	Leo Cancer Care	Wisconsin	Substantially Equivalent	510(k) traditional	JAK	accessdata.fda.gov
July 24, 2025	P230043/S002	Cologuard Plus	Exact Sciences Corporation	Wisconsin	30-day notice accepted	PMA 30-day notice	PHP	accessdata.fda.gov
July 24, 2025	P130017/S064	Cologuard® test	Exact Sciences Corporation	Wisconsin	30-day notice accepted	PMA 30-day notice	PHP	accessdata.fda.gov
July 24, 2025	P070004/S047	Sientra Silicone Gel Breast Implants	Tiger Aesthetics Medical, LLC	Wisconsin	30-day notice accepted	PMA 30-day notice	FTR	accessdata.fda.gov
July 18, 2025	P230043/S001	Cologuard Plus	Exact Sciences Corporation	Wisconsin	Approved	PMA real-time process supplement	PHP	accessdata.fda.gov
July 18, 2025	P130017/S063	Cologuard®	Exact Sciences Corporation	Wisconsin	Approved	PMA real-time process supplement	PHP	accessdata.fda.gov
July 16, 2025	K251342	EchoPAC Software Only / EchoPAC Plug-in	GE Medical Systems Ultrasound and Primary Care Diagnostics	Wisconsin	Substantially Equivalent	510(k) traditional	QIH	accessdata.fda.gov
July 14, 2025	P050052/S171	RADIESSE (+) Lidocaine	Merz North America, Inc.	Wisconsin	30-day notice accepted	PMA 30-day notice	LMH	accessdata.fda.gov
July 10, 2025	K251169	Vivid Pioneer	GE Medical Systems Ultrasound and Primary Care Diagnostics	Wisconsin	Substantially Equivalent	510(k) traditional	IYN	accessdata.fda.gov
July 9, 2025	K242562	Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P	Ge Medical Systems Information Technologies, Inc.	Wisconsin	Substantially Equivalent	510(k) traditional	MHX	accessdata.fda.gov
June 26, 2025	P050052/S170	RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline	Merz North America, Inc.	Wisconsin	30-day notice accepted	PMA 30-day notice	LMH	accessdata.fda.gov
June 26, 2025	P050037/S146	RADIESSE® Injectable Implant	Merz North America, Inc.	Wisconsin	30-day notice accepted	PMA 30-day notice	LMH	accessdata.fda.gov
June 16, 2025	P050052/S169	RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline	Merz North America, Inc.	Wisconsin	30-day notice accepted	PMA 30-day notice	LMH	accessdata.fda.gov
June 16, 2025	P050037/S145	RADIESSE® Injectable Implant	Merz North America, Inc.	Wisconsin	30-day notice accepted	PMA 30-day notice	LMH	accessdata.fda.gov
June 16, 2025	P040047/S077	COAPTITE®	Merz North America, Inc.	Wisconsin	30-day notice accepted	PMA 30-day notice	LNM	accessdata.fda.gov
June 10, 2025	P050052/S168	RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, Jawline indication	Merz North America, Inc.	Wisconsin	30-day notice accepted	PMA 30-day notice	LMH	accessdata.fda.gov
June 10, 2025	P050037/S144	RADIESSE® Injectable Implant	Merz North America, Inc.	Wisconsin	30-day notice accepted	PMA 30-day notice	LMH	accessdata.fda.gov
June 5, 2025	K243667	Sonic DL	Ge Medical Systems, LLC	Wisconsin	Substantially Equivalent	510(k) traditional	LNH	accessdata.fda.gov
May 29, 2025	K250543	Voluson Performance 16; Voluson Performance 18	GE Medical Systems Ultrasound and Primary Care Diagnostics	Wisconsin	Substantially Equivalent	510(k) traditional	IYN	accessdata.fda.gov

Applicants with the most decisions

Applicant	Decisions	Latest
Merz North America, Inc.	42	June 26, 2026
Exact Sciences Corporation	21	August 3, 2026
GE Medical Systems Ultrasound and Primary Care Diagnostics	18	September 16, 2026
Ge Medical Systems, LLC	10	June 24, 2026
Ge Medical Systems Information Technologies, Inc.	4	July 24, 2026
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC	3	October 2, 2026
Tiger Aesthetics Medical, LLC	3	April 22, 2026
GE Medical Systems Ultrasound and Primary care Diagnostics, LLC	2	October 2, 2026
Promega Corporation	2	September 15, 2026
Datex-Ohmeda, Inc.	2	July 28, 2026
Oculogica, Inc.	2	June 5, 2026
Inter-Med, Inc.	2	April 15, 2026
GE Healthcare	2	November 21, 2025
Natus Neurology Incorporated	2	January 22, 2025
Epic Systems Corporation	1	September 18, 2026
GE Medical Systems	1	August 13, 2026
Datex Ohmeda, Inc.	1	August 10, 2026
Relja Innovations, LLC	1	July 22, 2026
American Orthodontics	1	June 3, 2026
Neocoil, LLC	1	April 23, 2026

By panel

Panel	Decisions	Latest
Radiology	40	October 2, 2026
General, Plastic Surgery	37	June 26, 2026
Pathology	21	August 3, 2026
Gastroenterology, Urology	8	June 26, 2026
Cardiovascular	6	September 18, 2026
General Hospital	4	July 28, 2026
Neurology	4	June 5, 2026
Dental	3	June 3, 2026
Medical Genetics	2	September 15, 2026
Obstetrics/Gynecology	1	August 10, 2026
Orthopedic	1	July 22, 2026
Anesthesiology	1	January 3, 2025
Physical Medicine	1	November 12, 2024

By decision type

Decision type	Decisions	Latest
510(k) traditional	52	October 2, 2026
PMA 30-day notice	51	August 3, 2026
PMA real-time process supplement	10	June 2, 2026
510(k) special	6	July 22, 2026
PMA 180-day supplement	4	May 3, 2026
PMA original approval	2	September 15, 2026
De Novo	1	April 17, 2026
PMA panel track supplement	1	March 31, 2026
PMA 135-day supplement	1	November 20, 2025
PMA special supplement	1	August 27, 2025

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.