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
41929–41952 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 2013
MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD
K123738 · CAW
Nidek Medical Products, Inc.
Anesthesiology · 85d
Cleared Feb 28, 2013
LOFRIC SENSE
K123751 · EZD
Wellspect Healthcare
Gastroenterology & Urology · 84d
Cleared Feb 28, 2013
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
K123869 · LZA
Dehai (Shandong) Medical Gloves, Co.,...
General Hospital · 73d
Cleared Feb 28, 2013
CIRCUFLOW 5150
K123959 · JOW
Devon Medical, Inc.
Cardiovascular · 69d
Cleared Feb 28, 2013
COBAS INTEGRA BILIRUBIN DIRECT GEN.2
K123965 · CIG
Roche Diagnostics
Chemistry · 64d
Cleared Feb 28, 2013
QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
K130078 · GAW
Surgical Specialties Corp. Dba Angiotech
General & Plastic Surgery · 45d
Cleared Feb 28, 2013
EDRAIN CHEST DRAINAGE SYSTEM
K130131 · BTA
Atrium Medical Corp.
General & Plastic Surgery · 41d
Cleared Feb 27, 2013
DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS
K120592 · JOJ
Dana Products, Inc.
General Hospital · 365d
Cleared Feb 27, 2013
BIODESIGN ENT REPAIR GRAFT
K121360 · KHJ
Cook Biotech Incorprated
Ear, Nose, Throat · 296d
Cleared Feb 27, 2013
VITAL 5 RELEAF CATHETER
K122661 · BSO
Vital 5
General & Plastic Surgery · 180d
Cleared Feb 27, 2013
VITAL SYNC SYSTEM
K123002 · MWI
Covidien, Formerly Nellcor Puritan...
Cardiovascular · 153d
Cleared Feb 27, 2013
ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM
K123361 · FLL
Fiab Spa
General Hospital · 119d
Cleared Feb 27, 2013
XOFT AXXENT CERVICAL APPLICATORS
K123442 · JAQ
Icad, Inc.
Radiology · 111d
Cleared Feb 27, 2013
OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS
K123501 · JDI
Biomet, Inc.
Orthopedic · 106d
Cleared Feb 27, 2013
INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW)
K123672 · HWC
Inion OY
Orthopedic · 90d
Cleared Feb 27, 2013
INMODE HAIR REMOVAL (HR) DEVICE
K123682 · GEX
Inmode MD , Ltd.
General & Plastic Surgery · 89d
Cleared Feb 27, 2013
DIGITAL ELECTROCARDIOGRAPHS
K123816 · DPS
Shenzhen Biocare Electronics Co., Ltd.
Cardiovascular · 77d
Cleared Feb 27, 2013
QUATTRO AIR
K123979 · BZD
Resmed, Ltd.
Anesthesiology · 63d
Cleared Feb 27, 2013
PICCOLO COMPOSITE PLATE SYSTEM
K130061 · HRS
CarboFix Orthopedics , Ltd.
Orthopedic · 48d
Cleared Feb 27, 2013
SIMMETRY SACROILIAC JOINT FUSION SYSTEM
K130092 · OUR
Zyga Technology, Inc.
Orthopedic · 43d
Cleared Feb 27, 2013
SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER...
K130196 · MBI
Arthrocare Corp.
Orthopedic · 30d
Cleared Feb 27, 2013
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55
K130197 · ONB
Becton, Dickinson and Company
General Hospital · 30d
Cleared Feb 26, 2013
QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA
K120817 · MID
Inova Diagnostics, Inc.
Immunology · 344d
Cleared Feb 26, 2013
BRIDGE EXTRACELLULAR COLLEGEN MATRIX
K122502 · KGN
Harbor Medtech, Inc.
General & Plastic Surgery · 194d