Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
165169–165192 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 19, 1981
DISPOSABLE DIAPHRAGM DOME
K810009 · DRS
Medex, Inc.
Cardiovascular · 45d
Cleared Feb 19, 1981
LS1000 ELECTRONIC FOCUS
K810118 · IYN
Philips Medical Systems (Cleveland),...
Radiology · 34d
Cleared Feb 19, 1981
MODEL #53110 DISPOSABLE ANOSCOPE
K810227 · FER
Welch Allyn, Inc.
Chemistry · 23d
Cleared Feb 19, 1981
PORTABLE, BATTERY OPERATED DEFIBRILLATOR
K810237 · LDD
Honeywell, Inc.
Cardiovascular · 22d
Cleared Feb 19, 1981
CLINIGUARD STERILE
K810240 · KMF
Clinipad Corp.
General & Plastic Surgery · 22d
Cleared Feb 19, 1981
1.5` FOCAL SPOT RESOLUTION PATTERN
K810254 · IXF
Machlett Laboratories, Inc.
Radiology · 20d
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