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
70033–70056 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 20, 2004
THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM
K032064 · MQP
Theken Surgical,Llc
Orthopedic · 232d
Cleared Feb 20, 2004
INFRARED SCIENCES BREASTSCAN IR SYSTEM
K032350 · LHQ
Infrared Sciences Corp.
Radiology · 205d
Cleared Feb 20, 2004
STRYKER SPINE OASYS SYSTEM
K032394 · MNI
Howmedica Osteonics Corp.
Orthopedic · 200d
Cleared Feb 20, 2004
DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE
K032443 · IZI
Shimadzu Corp.
Radiology · 196d
Cleared Feb 20, 2004
PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T
K032979 · DQA
Philips Medical Systems, Inc.
Anesthesiology · 149d
Cleared Feb 20, 2004
COLOR LCD DISPLAY, MODEL RADIFORCE R22
K033466 · LLZ
Eizo Nanao Corporation
Radiology · 112d
Cleared Feb 20, 2004
PALINDROME 14.5 FR CHRONIC HEMODIALYSIS CATHETER
K033676 · MSD
Kendall
Gastroenterology & Urology · 88d
Cleared Feb 20, 2004
BRAIN PERFUSION OPTION
K033677 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 88d
Cleared Feb 20, 2004
TROPHYPAN AND TROPHYPAN C
K033690 · EHD
Trophy Radiologie
Radiology · 88d
Cleared Feb 20, 2004
MAMMOTOME EX HAND HELD SYSTEM
K033700 · KNW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 87d
Cleared Feb 20, 2004
AXSYM CORTISOL ASSAY
K033731 · JFT
Fujirebio Diagnostics,Inc.
Chemistry · 84d
Cleared Feb 20, 2004
SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES
K033805 · LXT
Synthes (Usa)
Orthopedic · 74d
Cleared Feb 20, 2004
ACE PROXIMAL HUMERAL NAIL SYSTEM
K033806 · HSB
Depuy Ace
Orthopedic · 74d
Cleared Feb 20, 2004
DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG...
K033809 · KLR
Dade Behring, Inc.
Toxicology · 74d
Cleared Feb 20, 2004
KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY
K033821 · LMC
Eastman Kodak Company
Radiology · 73d
Cleared Feb 20, 2004
ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM
K033878 · HSB
Depuy Ace
Orthopedic · 67d
Cleared Feb 20, 2004
DORC VITRECTOMY LENSES, MODEL 1284 SERIES
K033950 · HJK
Dutch Ophthalmic Research Center...
Ophthalmic · 60d
Cleared Feb 20, 2004
LAD (EPITURE EASYTOUCH), MODEL LAD-08
K033962 · GEX
Norwood Abbey , Ltd.
General & Plastic Surgery · 60d
Cleared Feb 20, 2004
HANSSON PIN SYSTEM
K033968 · HTY
Howmedica Osteonics Corp.
Orthopedic · 60d
Cleared Feb 20, 2004
EARLOOP PROCEDURE MASK
K034015 · FXX
Medipack Medical Packaging Mfg. Co.
General Hospital · 58d
Cleared Feb 20, 2004
PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100
K034054 · JAI
Med-Tec,Inc.
Radiology · 52d
Cleared Feb 20, 2004
WILSON-COOK USW CAP AND WIRE LOCK
K040137 · OCY
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 29d
Cleared Feb 20, 2004
OASIS BILIARY STENT INTRODUCTION SYSTEM
K040151 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 28d
Cleared Feb 20, 2004
OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS
K040199 · JDQ
Osseus, LLC
Orthopedic · 22d