FDA device clearances in Indiana: 184 since Nov 2024

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

The full list. FDA device clearances for applicants in Indiana: 184 rows for $9.20, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 10 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/indiana, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 27, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).

FDA made 184 device decisions for applicants in Indiana from November 13, 2024 to October 27, 2026: 75 510(k) clearances and De Novo grants and 109 PMA approvals and supplements, for 29 applicants. The newest, P830055/S381 on October 27, 2026, is ATTUNE Rotating Platform (RP) Total Knee System, and ATTUNE Revision Rotating Platform... from Depuy, Inc..

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

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184Decisions
75510(k) and De Novo
109PMA
October 27, 2026Latest decision

Newest decisions

The newest 100 of 184, 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 27, 2026	P830055/S381	ATTUNE Rotating Platform (RP) Total Knee System, and ATTUNE Revision Rotating Platform (RP) Knee System	Depuy, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	NJL	accessdata.fda.gov
October 27, 2026	P830055/S378	LCS® Knee System	Depuy, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	NJL	accessdata.fda.gov
October 26, 2026	P010014/S120	Oxford Partial Knee System	Biomet Manufacturing Corp	Indiana	30-day notice accepted	PMA 30-day notice	NRA	accessdata.fda.gov
October 16, 2026	P060037/S100	NexGen® LPS-Flex/LPS Mobile Bearing Knee System	Zimmer, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	NJL	accessdata.fda.gov
October 9, 2026	P830055/S379	ATTUNE Revision Knee System	Depuy, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	NJL	accessdata.fda.gov
October 8, 2026	P830055/S377	ATTUNE Rotating Platform (RP) Total Knee System, ATTUNE Revision Rotating Platform (RP) Total Knee System...	Depuy, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	NJL	accessdata.fda.gov
October 6, 2026	P010014/S119	Cementless Oxford Partial Knee System	Biomet Manufacturing Corp	Indiana	30-day notice accepted	PMA 30-day notice	NRA	accessdata.fda.gov
October 5, 2026	P830055/S380	LCS® Total Knee System	Depuy, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	NJL	accessdata.fda.gov
October 2, 2026	K260233	Elecsys EBV IgM	Roche Diagnostics	Indiana	Substantially Equivalent	510(k) traditional	LJN	accessdata.fda.gov
October 2, 2026	K260232	Elecsys EBV VCA IgG	Roche Diagnostics	Indiana	Substantially Equivalent	510(k) traditional	LSE	accessdata.fda.gov
October 2, 2026	K260221	Elecsys EBV EBNA IgG	Roche Diagnostics	Indiana	Substantially Equivalent	510(k) traditional	LSE	accessdata.fda.gov
September 30, 2026	K262712	Duet Spinal Fixation System	Duet Spine Holdings, LLC	Indiana	Substantially Equivalent	510(k) traditional	NKB	accessdata.fda.gov
September 25, 2026	P830055/S375	LCS® Total Knee System	Depuy, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	NJL	accessdata.fda.gov
September 24, 2026	P060037/S099	NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee System	Zimmer, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	NJL	accessdata.fda.gov
September 24, 2026	K262955	OsseoFit Stemless Shoulder System	Zimmer, Inc.	Indiana	Substantially Equivalent	510(k) special	PKC	accessdata.fda.gov
September 24, 2026	K261345	Pediatric Nailing Platform Femur	OrthoPediatrics Corp.	Indiana	Substantially Equivalent	510(k) traditional	HSB	accessdata.fda.gov
September 23, 2026	K261453	G7® Acetabular System	Zimmer Biomet	Indiana	Substantially Equivalent	510(k) traditional	LPH	accessdata.fda.gov
September 21, 2026	P830055/S351	Attune Revision Knee System	Depuy, Inc.	Indiana	Approved	PMA 180-day supplement	NJL	accessdata.fda.gov
September 17, 2026	P020018/S070	Zenith Fenestrated AAA Endovascular Graft, Zenith Iliac Branch	Cook, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	MIH	accessdata.fda.gov
September 10, 2026	P830055/S376	Attune Rotating Platform (RP) Total Knee System and the DePuy P.F.C. Sigma Rotating Platform (RP) Total...	Depuy, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	NJL	accessdata.fda.gov
September 9, 2026	P830055/S372	ATTUNE Rotating Platform (RP) Total Knee System, ATTUNE Cementless Rotating Platform (RP) Knee System, ATTUNE...	Depuy, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	NJL	accessdata.fda.gov
September 4, 2026	P070026/S129	CERAMAX CERAMIC HIP SYSTEM	DePuy Orthopaedics, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	MRA	accessdata.fda.gov
September 4, 2026	K262130	ATTUNE Revision Knee System	Depuy Orthopaedics, Inc.	Indiana	Substantially Equivalent	510(k) traditional	JWH	accessdata.fda.gov
September 3, 2026	P830055/S374	LCS(R) TOTAL KNEE SYSTEM, specifically ATTUNE Cruciate Retaining (CR), Posterior Stabilized (PS) and...	Depuy, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	NJL	accessdata.fda.gov
September 1, 2026	P010014/S118	Oxford Partial Knee Anatomic Vivacit-E Meniscal Bearings	Biomet Manufacturing Corp	Indiana	30-day notice accepted	PMA 30-day notice	NRA	accessdata.fda.gov
August 27, 2026	P830055/S373	LCS® Total Knee System	Depuy, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	NJL	accessdata.fda.gov
August 27, 2026	P070026/S130	CERAMAX Ceramic Hip System	DePuy Orthopaedics, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	MRA	accessdata.fda.gov
August 24, 2026	K253515	Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments	Biomet Orthopedics, Inc.	Indiana	Substantially Equivalent	510(k) traditional	JDI	accessdata.fda.gov
August 21, 2026	P830055/S371	LCS® Total Knee System	Depuy, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	NJL	accessdata.fda.gov
August 21, 2026	P830055/S369	LCS® Total Knee System- ATTUNE Revision Rotating Platform Knee System	Depuy, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	NJL	accessdata.fda.gov
August 19, 2026	P830055/S370	LCS(R) TOTAL KNEE SYSTEM	Depuy, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	NJL	accessdata.fda.gov
August 19, 2026	K261686	Elecsys Phospho-Tau (217P) Plasma	Roche Diagnostics	Indiana	Substantially Equivalent	510(k) traditional	SET	accessdata.fda.gov
August 13, 2026	K260211	Dashboard (P007000)	Hill-Rom, Inc.	Indiana	Substantially Equivalent	510(k) traditional	MSX	accessdata.fda.gov
August 5, 2026	P830055/S360	ATTUNE Revision Knee System	Depuy, Inc.	Indiana	Approved	PMA 180-day supplement	NJL	accessdata.fda.gov
August 4, 2026	P020018/S069	Zenith® Flex AAA Endovascular System; Zenith Fenestrated AAA Endovascular Graft (ZFEN); Zenith Iliac Branch...	Cook, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	MIH	accessdata.fda.gov
July 24, 2026	P070026/S128	CERAMAX® Ceramic Total Hip System	DePuy Orthopaedics, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	MRA	accessdata.fda.gov
July 20, 2026	P060037/S098	Nexgen LPS Femoral and Tibial Knee components	Zimmer, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	NJL	accessdata.fda.gov
July 20, 2026	P060037/S097	Creep Pressure Test Update for the Nexgen LPS Bearing Knee	Zimmer, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	NJL	accessdata.fda.gov
July 15, 2026	P830055/S368	LCS® Total Knee System	Depuy, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	NJL	accessdata.fda.gov
July 13, 2026	P010014/S117	Oxford Partial Knee System	Biomet Manufacturing Corp	Indiana	30-day notice accepted	PMA 30-day notice	NRA	accessdata.fda.gov
July 1, 2026	K253434	OSSTM Orthopedic Salvage System	Biomet, Inc.	Indiana	Substantially Equivalent	510(k) traditional	JDI	accessdata.fda.gov
June 29, 2026	P830055/S367	LCS® Total Knee System	Depuy, Inc.	Indiana	Approved	PMA special supplement	NJL	accessdata.fda.gov
June 18, 2026	K252982	CONDUIT ZERO-P VA Secured Spacer System	Avalign Technologies, Inc.	Indiana	Substantially Equivalent	510(k) traditional	OVE	accessdata.fda.gov
June 16, 2026	K261683	Augment Off-Axis Instrument System	Zimmer, Inc.	Indiana	Substantially Equivalent	510(k) special	PHX	accessdata.fda.gov
June 16, 2026	K260831	Z1 Hip System	Zimmer, Inc.	Indiana	Substantially Equivalent	510(k) traditional	LZO	accessdata.fda.gov
June 12, 2026	K252323	cobas pulse blood glucose monitoring system	Roche Diagnostics	Indiana	Substantially Equivalent	De Novo (dual track)	PZI	accessdata.fda.gov
June 3, 2026	P830055/S366	LCS® Total Knee System	Depuy, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	NJL	accessdata.fda.gov
June 3, 2026	P070026/S127	CERAMAX CERAMIC HIP SYSTEM	DePuy Orthopaedics, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	MRA	accessdata.fda.gov
May 28, 2026	K251840	Zimmer® Persona® Personalized Knee System	Zimmer, Inc.	Indiana	Substantially Equivalent	510(k) traditional	MBH	accessdata.fda.gov
May 27, 2026	P010014/S112	Oxford Partial Knee System; Cementless OxfordPartial Knee System	Biomet Manufacturing Corp	Indiana	Approved	PMA 180-day supplement	NRA	accessdata.fda.gov
May 22, 2026	K252887	DePuy ATTUNE Knee System	DePuy Orthopaedics, Inc.	Indiana	Substantially Equivalent	510(k) traditional	OIY	accessdata.fda.gov
May 21, 2026	P020018/S068	Zenith (Flex) AAA Endovascular Graft; Zenith Renu AAA Ancillary Graft; Zenith Fenestrated AAA Endovascular...	Cook, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	MIH	accessdata.fda.gov
May 21, 2026	K261291	Nisus NPWT Canister 500-mL (CPC-500)	Cork Medical	Indiana	Substantially Equivalent	510(k) special	OMP	accessdata.fda.gov
May 19, 2026	K251270	Taperloc® Complete Hip Stem	Biomet, Inc.	Indiana	Substantially Equivalent	510(k) traditional	LPH	accessdata.fda.gov
May 12, 2026	P010014/S116	Oxford® Partial Knee System	Biomet Manufacturing Corp	Indiana	30-day notice accepted	PMA 30-day notice	NRA	accessdata.fda.gov
April 30, 2026	K260323	OrthoPediatrics® Locking Cannulated Blade Plate System	OrthoPediatrics Corp.	Indiana	Substantially Equivalent	510(k) traditional	HRS	accessdata.fda.gov
April 29, 2026	P990056/S046	ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET	Roche Diagnostics Corp.	Indiana	30-day notice accepted	PMA 30-day notice	MTF	accessdata.fda.gov
April 29, 2026	P070026/S125	Ceramax® Ceramic Hip System	DePuy Orthopaedics, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	MRA	accessdata.fda.gov
April 29, 2026	P000027/S045	ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK	Roche Diagnostics Corp.	Indiana	30-day notice accepted	PMA 30-day notice	LTJ	accessdata.fda.gov
April 27, 2026	K260182	Avenir® Müller Stem; Avenir Complete Hip System	Zimmer, Inc.	Indiana	Substantially Equivalent	510(k) traditional	LZO	accessdata.fda.gov
April 21, 2026	P020018/S067	Zenith Flex AAA Endovascular Graft Bifurcated Main Body; Zenith Renu AAA Ancillary Graft Converter; Zenith...	Cook, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	MIH	accessdata.fda.gov
April 20, 2026	P010014/S115	Oxford® Partial Knee System	Biomet Manufacturing Corp	Indiana	30-day notice accepted	PMA 30-day notice	NRA	accessdata.fda.gov
April 15, 2026	K252404	Comprehensive Reverse Shoulder - HA Glenosphere Baseplates	Biomet Orthopedics	Indiana	Substantially Equivalent	510(k) traditional	PHX	accessdata.fda.gov
April 13, 2026	K253592	Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive...	Zimmer, Inc.	Indiana	Substantially Equivalent	510(k) traditional	MBF	accessdata.fda.gov
April 13, 2026	K252280	Elecsys Anti-SARS-CoV-2 S	Roche Diagnostics	Indiana	Substantially Equivalent	510(k) traditional	QVP	accessdata.fda.gov
April 10, 2026	P830055/S362	LCS® Total Knee System	Depuy, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	NJL	accessdata.fda.gov
April 10, 2026	P070026/S124	Ceramax Ceramic Hip System	DePuy Orthopaedics, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	MRA	accessdata.fda.gov
April 7, 2026	K260049	Elecsys Anti-HBc IgM	Roche Diagnostics	Indiana	Substantially Equivalent	510(k) traditional	SEI	accessdata.fda.gov
April 7, 2026	K260046	Elecsys Anti-HBc II	Roche Diagnostics	Indiana	Substantially Equivalent	510(k) traditional	SEI	accessdata.fda.gov
April 2, 2026	K260026	Tina-quant Cardiac high sensitivity CRP III	Roche Diagnostics	Indiana	Substantially Equivalent	510(k) traditional	NQD	accessdata.fda.gov
March 27, 2026	P830055/S363	LCS® Total Knee System	Depuy, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	NJL	accessdata.fda.gov
March 17, 2026	K253863	GUARDIAN Quick Dip Residual Chlorine (5212)	Serim Research	Indiana	Substantially Equivalent	510(k) traditional	FKJ	accessdata.fda.gov
March 12, 2026	K253566	Affixus Retrograde Femoral Nailing System	Zimmer, Inc.	Indiana	Substantially Equivalent	510(k) traditional	HSB	accessdata.fda.gov
March 11, 2026	K260783	Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One	Kulzer, LLC	Indiana	Substantially Equivalent	510(k) traditional	EBF	accessdata.fda.gov
March 9, 2026	P020018/S066	Zenith Flex AAA Endovascular System and Zenith Iliac Branch	Cook, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	MIH	accessdata.fda.gov
March 9, 2026	K253189	Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)	Zimmer, Inc.	Indiana	Substantially Equivalent	510(k) traditional	MBH	accessdata.fda.gov
March 6, 2026	P010014/S114	Oxford Cementless Partial Knee System	Biomet Manufacturing Corp	Indiana	30-day notice accepted	PMA 30-day notice	NRA	accessdata.fda.gov
February 27, 2026	P990056/S045	Elecsys total PSA assay	Roche Diagnostics Corp.	Indiana	30-day notice accepted	PMA 30-day notice	MTF	accessdata.fda.gov
February 27, 2026	P000027/S044	Elecsys free PSA assay	Roche Diagnostics Corp.	Indiana	30-day notice accepted	PMA 30-day notice	LTJ	accessdata.fda.gov
February 13, 2026	P830055/S361	LCS® Total Knee System	Depuy, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	NJL	accessdata.fda.gov
February 13, 2026	P830055/S358	LCS® Total Knee System	Depuy, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	NJL	accessdata.fda.gov
February 12, 2026	P830055/S357	LCS® Total Knee System	Depuy, Inc.	Indiana	Approved	PMA special supplement	NJL	accessdata.fda.gov
February 12, 2026	K253491	ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions	Roche Diagnostics	Indiana	Substantially Equivalent	510(k) traditional	CEM	accessdata.fda.gov
February 12, 2026	K253490	Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions	Roche Diagnostics	Indiana	Substantially Equivalent	510(k) traditional	CFR	accessdata.fda.gov
February 4, 2026	K252623	G7® Revision Acetabular System	Zimmer, Inc.	Indiana	Substantially Equivalent	510(k) traditional	LPH	accessdata.fda.gov
January 30, 2026	P830055/S359	LCS® Total Knee System	Depuy, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	NJL	accessdata.fda.gov
January 16, 2026	P830055/S356	LCS® Total Knee System	Depuy, Inc.	Indiana	Approved	PMA special supplement	NJL	accessdata.fda.gov
January 16, 2026	P060037/S096	NexGen® LPS-Flex / LPS Mobile Bearing Knee System	Zimmer, Inc.	Indiana	Approved	PMA special supplement	NJL	accessdata.fda.gov
January 16, 2026	P010014/S113	Oxford Partial Knee System	Biomet Manufacturing Corp	Indiana	Approved	PMA special supplement	NRA	accessdata.fda.gov
January 8, 2026	P070026/S118	Ceramax® Ceramic Total Hip System	DePuy Orthopaedics, Inc.	Indiana	Approved	PMA 135-day supplement	MRA	accessdata.fda.gov
December 19, 2025	K254063	iCEM Universal Plus	Kulzer, LLC	Indiana	Substantially Equivalent	510(k) abbreviated	EMA	accessdata.fda.gov
December 18, 2025	P830055/S346	ATTUNE Revision Rotating Platform (RP) Knee System	Depuy, Inc.	Indiana	Approved	PMA 180-day supplement	NJL	accessdata.fda.gov
December 17, 2025	K253839	Elecsys Anti-SARS-CoV-2	Roche Diagnostics	Indiana	Substantially Equivalent	510(k) special	QVP	accessdata.fda.gov
December 15, 2025	P830055/S355	LCS Total Knee System	Depuy, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	NJL	accessdata.fda.gov
December 11, 2025	P830055/S354	LCS® Total Knee System	Depuy, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	NJL	accessdata.fda.gov
December 9, 2025	P830055/S353	LCS® Total Knee System	Depuy, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	NJL	accessdata.fda.gov
December 9, 2025	P070026/S123	Ceramax Ceramic Hip System	DePuy Orthopaedics, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	MRA	accessdata.fda.gov
November 26, 2025	P830055/S352	LCS® Total Knee System	Depuy, Inc.	Indiana	30-day notice accepted	PMA 30-day notice	NJL	accessdata.fda.gov
October 24, 2025	K253188	CoaguChek XS Plus System	Roche Diagnostics	Indiana	Substantially Equivalent	510(k) special	GJS	accessdata.fda.gov
October 16, 2025	K252024	NeurAxis IB-Stim (01-1020)	Neuraxis	Indiana	Substantially Equivalent	510(k) traditional	QHH	accessdata.fda.gov

Applicants with the most decisions

Applicant	Decisions	Latest
Depuy, Inc.	46	October 27, 2026
Zimmer, Inc.	25	October 16, 2026
Roche Diagnostics	19	October 2, 2026
DePuy Orthopaedics, Inc.	16	September 4, 2026
Biomet Manufacturing Corp	15	October 26, 2026
Roche Diagnostics Corp.	13	April 29, 2026
OrthoPediatrics Corp.	8	September 24, 2026
Cook, Inc.	7	September 17, 2026
Zimmer Biomet	6	September 23, 2026
Kulzer, LLC	3	March 11, 2026
Biomet, Inc.	2	July 1, 2026
Avalign Technologies, Inc.	2	June 18, 2026
Cork Medical	2	May 21, 2026
Biomet Orthopedics	2	April 15, 2026
Serim Research	2	March 17, 2026
Neuraxis	2	October 16, 2025
Ignite Orthomotion	2	September 2, 2025
Duet Spine Holdings, LLC	1	September 30, 2026
Depuy Orthopaedics, Inc.	1	September 4, 2026
Biomet Orthopedics, Inc.	1	August 24, 2026

By panel

Panel	Decisions	Latest
Orthopedic	128	October 27, 2026
Microbiology	19	October 2, 2026
Immunology	10	August 19, 2026
Cardiovascular	8	September 17, 2026
Clinical Chemistry	5	June 12, 2026
Gastroenterology, Urology	4	March 17, 2026
General, Plastic Surgery	3	May 21, 2026
Dental	2	March 11, 2026
Unknown	2	September 24, 2025
Hematology	1	October 24, 2025
General Hospital	1	June 3, 2025
Anesthesiology	1	April 25, 2025

By decision type

Decision type	Decisions	Latest
PMA 30-day notice	86	October 27, 2026
510(k) traditional	65	October 2, 2026
PMA 180-day supplement	12	September 21, 2026
510(k) special	8	September 24, 2026
PMA special supplement	6	June 29, 2026
PMA 135-day supplement	2	January 8, 2026
PMA panel track supplement	2	May 30, 2025
De Novo (dual track)	1	June 12, 2026
510(k) abbreviated	1	December 19, 2025
PMA real-time process supplement	1	November 13, 2024

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.