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
71137–71160 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 2003
TARAS THREADED FIXATION PIN
K032532 · JDW
Union Surgical, LLC
Orthopedic · 68d
Cleared Oct 22, 2003
SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS
K032559 · HRS
Synthes (Usa)
Orthopedic · 64d
Cleared Oct 22, 2003
CYNOSURE PHOTOGENICA VL
K032565 · GEX
Cynosure, Inc.
General & Plastic Surgery · 63d
Cleared Oct 22, 2003
PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
K032580 · FGE
Ev3, Inc.
Gastroenterology & Urology · 62d
Cleared Oct 22, 2003
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
K032590 · HCG
MicroVention, Inc.
Neurology · 61d
Cleared Oct 22, 2003
REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH
K032632 · DWF
Estech, Inc.
Cardiovascular · 57d
Cleared Oct 22, 2003
STS SCREW
K032682 · HWC
Ortho-Pro, LLC
Orthopedic · 54d
Cleared Oct 22, 2003
ASCENSION MODULAR RADIAL HEAD
K032686 · KWI
Ascension Orthopedics, Inc.
Orthopedic · 54d
Cleared Oct 22, 2003
CARDICARE MODEL MT-301F & MT-301C
K032714 · FLL
Lumiscope Co., Inc.
General Hospital · 50d
Cleared Oct 22, 2003
ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIES
K032726 · LPH
Zimmer, Inc.
Orthopedic · 49d
Cleared Oct 22, 2003
MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT...
K032929 · FGE
Abbott Vascular, Inc.
Gastroenterology & Urology · 30d
Cleared Oct 22, 2003
PTA BALLOON CATHETER
K032931 · DQY
Cook, Inc.
Cardiovascular · 30d
Cleared Oct 22, 2003
AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION...
K032941 · IPF
Rich-Mar Corp.
Physical Medicine · 30d
Cleared Oct 22, 2003
MEDI-HEAT INFANT HEEL WARMER
K032989 · MPO
Mediheat, Inc.
Physical Medicine · 28d
Cleared Oct 22, 2003
FORTE GAMMA CAMERA SYSTEM
K033254 · KPS
Adac Laboratories
Radiology · 14d
Cleared Oct 21, 2003
COMBI-SCREEN, MODELS 10SL AND 11SL
K023885 · JIL
Analyticon Biotechnologies AG
Chemistry · 334d
Cleared Oct 21, 2003
ISO-ELASTIC CERCLAGE SYSTEM
K030256 · JDQ
Kinamed, Inc.
Orthopedic · 270d
Cleared Oct 21, 2003
BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES...
K030348 · FIP
Biolab Equipment Canada , Ltd.
Gastroenterology & Urology · 260d
Cleared Oct 21, 2003
LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER...
K032074 · JJY
Cliniqa Corporation
Chemistry · 106d
Cleared Oct 21, 2003
BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY...
K032166 · GQG
Binax, Inc.
Microbiology · 97d
Cleared Oct 21, 2003
ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM
K032312 · DQY
Medtronic Vascular
Cardiovascular · 85d
Cleared Oct 21, 2003
HEMEDEX CRANIAL BOLT MODELS, 3601, 3602
K032337 · GWM
Hemedex Incorporated
Neurology · 84d
Cleared Oct 21, 2003
THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT
K032351 · DZE
BioHorizons Implant Systems, Inc.
Dental · 83d
Cleared Oct 21, 2003
MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI
K032465 · EBZ
Satelec
Dental · 71d