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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
147817–147840 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 1985
SUNBIRD (POWERED WHEELCHAIR)
K852379 · ITI
Venturego, Inc.
Physical Medicine · 63d
Cleared Aug 07, 1985
SPARROW MOTORIZED SCOOTER
K852380 · INI
Venturego, Inc.
Physical Medicine · 63d
Cleared Aug 07, 1985
AMRESCO SUBST CONCEN, PRO #2432,BUF,NAD,2455,TRI
K852948 · CFJ
Amresco, Inc.
Chemistry · 27d
Cleared Aug 07, 1985
BONE RONGEURS
K852993
The Huxley Instrument Corp.
General & Plastic Surgery · 23d
Cleared Aug 07, 1985
COBAS REAGENT FOR LIDOCAINE & CALIBRATORS
K853010 · KLR
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Aug 07, 1985
STILLE ANGULAR RONGEUR, 8-3/4 SS 410
K853016
The Huxley Instrument Corp.
Dental · 21d
Cleared Aug 07, 1985
OPTIMATE DIGOXIN TEST
K853021 · DPB
Miles Laboratories, Inc.
Toxicology · 20d
Cleared Aug 07, 1985
TAN MODEL I
K853046 · FTC
Philip Munsterman Tan, Inc.
General & Plastic Surgery · 19d
Cleared Aug 07, 1985
RESPIR GARD-II FACE MASK CORRUGATED TUBING
K853056 · IYT
Marquest Medical Products, Inc.
Radiology · 19d
Cleared Aug 07, 1985
MEDUS GMBH
K853153 · GEN
Corkes Medical Co.
General & Plastic Surgery · 9d
Cleared Aug 06, 1985
AIRLIFE ELECTRONIC INCENTIVE SPIROMETER
K851334 · BWF
American Pharmaseal Div. Ahsc
Anesthesiology · 127d
Cleared Aug 06, 1985
DIASCAN BLOOD GLUCOSE SELF-MONITOR TEST STRIPS
K851618 · CGA
Home Diagnostics, Inc.
Chemistry · 110d
Cleared Aug 06, 1985
MEDI-COMP NEONATAL OXYGEN HOOD
K851666 · BYL
Medicomp, Inc.
Anesthesiology · 105d
Cleared Aug 06, 1985
APM DISPOS. BLOOD PRESSURE TRANSDUCER
K851888 · DRS
Honeywell, Inc.
Cardiovascular · 97d
Cleared Aug 06, 1985
LITEGUARD 9
K851924 · LDD
Temtech , Ltd.
Cardiovascular · 96d
Cleared Aug 06, 1985
SARACAP RESPIRATORY MONITOR
K852062 · CCK
Alleghany Intl. Medical Technology
Anesthesiology · 89d
Cleared Aug 06, 1985
MEDTRONIC MODEL 5561
K852356 · DTD
Medtronic Vascular
Cardiovascular · 64d
Cleared Aug 06, 1985
CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA
K852435 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 57d
Cleared Aug 06, 1985
HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193
K853003 · JJE
Hi Chem, Inc.
Chemistry · 21d
Cleared Aug 06, 1985
DR. HESSEL'S VACUUM EXTRACTOR
K853037
Medic Group of Scandinavia, Inc.
General & Plastic Surgery · 19d
Cleared Aug 06, 1985
MCKNIFE
K853103 · GDX
Medical Dimensions
General & Plastic Surgery · 14d
Cleared Aug 06, 1985
ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR
K853114 · GAD
Australian Biomedical Corporation , Ltd.
General & Plastic Surgery · 13d
Cleared Aug 06, 1985
BEAVER MULTIPURPOSE SAPPHIRE KNIFE
K853129 · HNN
Rudolph Beaver, Inc.
Ophthalmic · 11d
Cleared Aug 06, 1985
RESPIR THER HUMID CONTAIN STERILE WATER FOR USP
K853146 · BTT
Automatic Liquid Packaging, Inc.
Anesthesiology · 8d