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
58633–58656 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 2007
PRECIOUS PLUS GUIDE CATHETER
K072316 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 31d
Cleared Sep 14, 2007
SIASCOPE V
K062736 · PSN
Astron Clinica Limited
General & Plastic Surgery · 366d
Cleared Sep 14, 2007
TRANS-CATHETER EXTRACTOR
K063048 · ODY
Tran Pa-C, Inc.
General Hospital · 345d
Cleared Sep 14, 2007
OLYMPUS CAPSULE ENDOSCOPE SYSTEM
K063259 · NEZ
Olympus Medical Systems Corporation
Gastroenterology & Urology · 319d
Cleared Sep 14, 2007
MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM
K063481 · FGE
Abbott Vascular, Inc.
Gastroenterology & Urology · 301d
Cleared Sep 14, 2007
KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662
K070685 · FRO
Tyco Healthcare
General & Plastic Surgery · 186d
Cleared Sep 14, 2007
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K070742 · KWP
Medtronic Sofamor Danek
Orthopedic · 182d
Cleared Sep 14, 2007
DISPOSABLE LAPAROSCOPIC INSTRUMENT
K070812 · GEI
Modern Medical Equipment Mfg., Ltd.
General & Plastic Surgery · 172d
Cleared Sep 14, 2007
BACTRACK LCD ALCOHOL DETECTOR
K071067 · DJZ
Khn Solutions, LLC
Chemistry · 151d
Cleared Sep 14, 2007
POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH...
K071170 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 140d
Cleared Sep 14, 2007
TOTAL PROTEIN URINE/CSF GEN.3
K071239 · JGQ
Roche Diagnostics
Chemistry · 134d
Cleared Sep 14, 2007
BRM3 BRAIN MONITOR
K071449 · OMA
Brainz Instruments , Ltd.
Neurology · 113d
Cleared Sep 14, 2007
COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY
K071499 · JWH
Aesculap Implant Systems, Inc.
Orthopedic · 106d
Cleared Sep 14, 2007
AUTOSAFE-REFLEX SAFETY NEEDLE, AUTOSAFE ADVANTAGE SAFETY NEEDLE
K071567 · FMI
Autosafe-Refelx, Inc.
General Hospital · 99d
Cleared Sep 14, 2007
EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND...
K071651 · ODE
Endogastric Solutions, Inc.
Gastroenterology & Urology · 88d
Cleared Sep 14, 2007
SIEMENS DIAGNOSTIC ULTRASOUND SYSTEMS
K072090 · IYN
Siemens Medical Solutions USA, Inc.,...
Radiology · 46d
Cleared Sep 14, 2007
VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601
K072246 · JJY
Maine Standards Co.
Immunology · 32d
Cleared Sep 14, 2007
CAPLESS LI PEDICLE SCREW SYSTEM
K072282 · MNH
X-Spine Systems, Inc.
Orthopedic · 29d
Cleared Sep 14, 2007
GREINER VACUETTE QUICKSHIELD COMPLETE
K072320 · FMI
Greiner Bio-One North America, Inc.
General Hospital · 25d
Cleared Sep 14, 2007
GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT
K072439 · KGI
Ge Medical Systems Ultrasound and...
Radiology · 15d
Cleared Sep 14, 2007
INTEGRATED BRACHYTHERAPY UNIT - DIGITAL
K072445 · KPQ
Nucletron Corp.
Radiology · 15d
Cleared Sep 13, 2007
MRSASELECT
K070361 · JSO
Bio-Rad
Microbiology · 218d
Cleared Sep 13, 2007
ARCHITECT STAT TROPONIN-1
K070640 · MMI
Fisher Diagnostics
Chemistry · 190d
Cleared Sep 13, 2007
STRYKER MODULAR HIP SYSTEM
K071082 · LZO
Howmedica Osteonics Corp.
Orthopedic · 149d