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
61441–61464 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 13, 2006
HABIB 4X LAPAROSCOPIC
K062935 · GEI
Rita Medical Systems
General & Plastic Surgery · 15d
Cleared Oct 13, 2006
PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS
K062972 · JJX
Roche Diagnostics Corp.
Chemistry · 14d
Cleared Oct 12, 2006
MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI...
K060458 · FEB
Langford IC Systems, Inc.
General Hospital · 232d
Cleared Oct 12, 2006
THERMASSAGE
K061001 · GEI
Thermage, Inc.
General & Plastic Surgery · 184d
Cleared Oct 12, 2006
CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND...
K061046 · NQH
Cardiomems, Inc.
Cardiovascular · 181d
Cleared Oct 12, 2006
ZIMMER CONTOUR CERAMIC ABUTMENT, MODELS ZRA341S, ZRA342S, KRA451S, ZRA452S
K061847 · NHA
Zimmer Dental, Inc.
Dental · 104d
Cleared Oct 12, 2006
ESCORT M8 VITAL SIGNS PATIENT MONITOR, MODEL 3810
K062144 · MHX
Invivo Corporation
Cardiovascular · 77d
Cleared Oct 12, 2006
MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/ML)
K062927 · LRG
Dade Behring, Inc.
Microbiology · 14d
Cleared Oct 11, 2006
SINCLAIR SEBORRHEA EMULSION
K050158 · FRO
Sinclair Pharmaceuticals, Ltd.
General & Plastic Surgery · 624d
Cleared Oct 11, 2006
VANGUARD REPROCESSED SUTURE PASSER
K053585 · NLM
Ascent Healthcare Solutions
Gastroenterology & Urology · 292d
Cleared Oct 11, 2006
CARDIOFLON, CARDIOXYL
K060163 · GAT
Peters Surgical
General & Plastic Surgery · 261d
Cleared Oct 11, 2006
POWDERED VINYL PATIENT EXAMINATION GLOVES
K062520 · LYZ
Jiangsu Jaysun Glove Co., Ltd.
General Hospital · 44d
Cleared Oct 11, 2006
MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
K062663 · MSH
Moldex/Metric, Inc.
General Hospital · 34d
Cleared Oct 11, 2006
TRIO + SPINAL SYSTEM
K062698 · MNI
Stryker Spine
Orthopedic · 30d
Cleared Oct 11, 2006
CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE
K062727 · GCJ
Medtronic Vascular
General & Plastic Surgery · 28d
Cleared Oct 11, 2006
WU'S 3-WHEELED NEO SCOOTER, MODEL WT-T3E
K062790 · INI
Wu'S Tech Co., Ltd.
Physical Medicine · 23d
Cleared Oct 11, 2006
COLLAGEN DENTAL MENBRANE - CONFORMABLE II
K062881 · NPL
Collagen Matrix, Inc.
Dental · 15d
Cleared Oct 10, 2006
MODIFICATION TO PHYTACARE ALGINATE HYDROGEL WOUND FILLER
K053538 · FRO
Curapharm, Inc.
General & Plastic Surgery · 294d
Cleared Oct 10, 2006
BEAVERITE BODY FAT SCALES, MODELS 8901, 8903, 8905, 8909, 8911, 8915, 9563...
K060538 · MNW
Beaverite International Limited
Gastroenterology & Urology · 224d
Cleared Oct 10, 2006
GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910
K061417 · GEI
Genicon
General & Plastic Surgery · 141d
Cleared Oct 10, 2006
STRYKER RF PARALLEL BIPOLAR ADAPTOR CABLE
K061660 · GEI
Stryker Instruments
General & Plastic Surgery · 119d
Cleared Oct 10, 2006
BASX BLADELESS TROCAR
K062209 · GCJ
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 70d
Cleared Oct 10, 2006
STARION INSTRUMENTS THERMAL LITIGATING SHEARS
K062257 · GEI
Starion Instruments
General & Plastic Surgery · 67d
Cleared Oct 10, 2006
KARMA MANUAL WHEELCHAIR, MODELS S-ERGO 305 AND S-ERGO 105
K062309 · IOR
Karma Medical Products Co., Ltd.
Physical Medicine · 63d