FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
164329–164352 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 19, 1981
MICROPROCESSOR CONTROLLED ELECTROCARDIO
K810263 · DPS
Honeywell, Inc.
Cardiovascular · 20d
Cleared Feb 19, 1981
DIRECT CURRENT BONE GROWTH STIM. AN. PAD
K810271
Andover Medical, Inc.
Toxicology · 17d
Cleared Feb 19, 1981
DIALYSATE CONCENTRATE FOR HEMODIALYSIS
K810280 · KPO
Cobe Laboratories, Inc.
Gastroenterology & Urology · 17d
Cleared Feb 19, 1981
DIGOXIN RIA ASSAY
K810296 · DON
Ria Diagnostics
Toxicology · 15d
Cleared Feb 19, 1981
ARTERIAL MICROCOLLECTION SET
K810308 · CHL
American Dade
Hematology · 14d
Cleared Feb 19, 1981
WILLIAM HARVEY FLOWMETER SYSTEM
K810314 · BYM
C.R. Bard, Inc.
Anesthesiology · 14d
Cleared Feb 19, 1981
CORDIS STIMUCORD EXTERNAL NEUTRAL STIM
K810319 · GZB
Cordis Corp.
Neurology · 13d
Cleared Feb 17, 1981
ALPHA-ANTIPLASM ASSAY
K802840 · LGP
American Dade
Chemistry · 97d
Cleared Feb 17, 1981
GARDNER KUPHOSIS DISTRACTOR
K802851
Downs Surgical , Ltd.
General & Plastic Surgery · 97d
Cleared Feb 17, 1981
PROTEOLYTIC ENZYME CONTROL
K803110 · LGP
American Dade
Chemistry · 69d
Cleared Feb 17, 1981
SOF-BAND HIGH STRETCH BANDAGES
K810137 · FQM
Johnson & Johnson Professionals, Inc.
General Hospital · 27d
Cleared Feb 17, 1981
ATMOSET
K810148 · ETF
Jedmed Instrument Co.
Ear, Nose, Throat · 27d
Cleared Feb 17, 1981
IRRIJET
K810209 · KYZ
Ackrad Laboratories
General Hospital · 22d
Cleared Feb 13, 1981
POLARIS SPECTACLE FRAMES & LENSES
K802082 · HQY
Polaris Optics USA, Inc.
Ophthalmic · 169d
Cleared Feb 13, 1981
SOLVALINE
K802790 · KKX
Secol Co.
General Hospital · 101d
Cleared Feb 13, 1981
CORDIS DOW C-DAK 1.3MRC ARTIF. KIDNEY
K802893 · FJI
Cordis Corp.
Gastroenterology & Urology · 88d
Cleared Feb 13, 1981
ANSPACH MENISECTOMY KNIFE
K803178 · FZS
The Anspach Effort, Inc.
General & Plastic Surgery · 59d
Cleared Feb 13, 1981
DAVOL SILICONE SHEATH SUMP DRAIN
K810158 · GBS
C.R. Bard, Inc.
General & Plastic Surgery · 23d
Cleared Feb 13, 1981
DISPOSABLE SURGERY CAPS & HOODS
K810199 · FYF
Anago, Inc.
General & Plastic Surgery · 21d
Cleared Feb 13, 1981
OPTIPORE SCRUB SPONGE
K810200 · EFQ
Bio Syntec
General & Plastic Surgery · 21d
Cleared Feb 13, 1981
MINOR SURGERY LIGHT
K810207 · GBC
Cavitron Corp.
General & Plastic Surgery · 18d
Cleared Feb 13, 1981
SUPINE STRESS SYSTEM
K810238 · BXB
O'Neill
Physical Medicine · 16d
Cleared Feb 13, 1981
INTERMEDICS CYBERLITH I UNIPOLAR CARDIAC
K810384
Intermedics, Inc.
Cardiovascular
Cleared Feb 12, 1981
MULTI-PROGRAMMABLE PACEMAKER & PROGRMR.
K801584 · DXY
Medtronic Vascular
Cardiovascular · 216d