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
72817–72840 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 2003
DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING...
K030343 · HAW
Gyrus Ent LLC
Neurology · 88d
Cleared May 02, 2003
TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
K030346 · LNS
Fmd, LLC
Gastroenterology & Urology · 88d
Cleared May 02, 2003
20.1 MONOCHROME LCD MONITOR, RADIFORCE G20
K030347 · LLZ
Eizo Nanao Corporation
Radiology · 88d
Cleared May 02, 2003
HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM 940, BFM 945...
K030349 · MNW
Bonso Electronics International, Inc.
Gastroenterology & Urology · 88d
Cleared May 02, 2003
FLUORILAQ
K030488 · LBH
Pascal Co., Inc.
Dental · 77d
Cleared May 02, 2003
BRM2 BRAIN MONITOR
K030489 · OLT
Brainz Instruments , Ltd.
Neurology · 77d
Cleared May 02, 2003
HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS
K030515 · CBK
Hans Rudolph, Inc.
Anesthesiology · 72d
Cleared May 02, 2003
KAVO EVEREST G-BLANK, KAVO EVEREST G-CERAM, COATING CERAMIC LF-3-PFM, GLAZE...
K030607 · EIH
Kavo America
Dental · 65d
Cleared May 02, 2003
CLEARBLUE EASY DIGITAL PREGNANCY TEST
K030659 · LCX
Unipath , Ltd.
Chemistry · 60d
Cleared May 02, 2003
ANA DETECT
K030929 · LJM
Orgentec Diagnostika GmbH
Immunology · 39d
Cleared May 02, 2003
POWDERED VINYL EXAM GLOVES, WHITE
K030997 · LYZ
Heyuan Hongli Industries, Inc.
General Hospital · 35d
Cleared May 02, 2003
TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES...
K031062 · MEG
Taiject Medical Device Co., Ltd.
General Hospital · 29d
Cleared May 02, 2003
SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR
K031223 · DTZ
Dideco S.P.A.
Cardiovascular · 14d
Cleared May 02, 2003
STERRAD CYCLESURE BIOLOGICAL INDICATOR
K031226 · FRC
Advanced Sterilization Products
General Hospital · 14d
Cleared May 02, 2003
GE PROPELLER IMAGING OPTION FOR MRI
K031230 · LNH
GE Medical Systems
Radiology · 14d
Cleared May 02, 2003
RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR
K031257 · GEI
Rita Medical Systems, Inc.
General & Plastic Surgery · 11d
Cleared May 02, 2003
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
K031269 · MSW
Beckman Coulter, Inc.
Immunology · 11d
Cleared May 02, 2003
ACCESS OV MONITOR ASSAY
K031297 · LTK
Beckman Coulter, Inc.
Immunology · 8d
Cleared May 01, 2003
SMALL VOLUME NEBULIZER
K023602 · CAF
Allegiance Healthcare Corporation
Anesthesiology · 185d
Cleared May 01, 2003
SUNPEX TECHNOLOGIES MODEL PW
K024175 · ITI
Sunpex Technology Co., Ltd.
Physical Medicine · 134d
Cleared May 01, 2003
CHUMP
K030017 · IOR
Colours 'N Motion
Physical Medicine · 119d
Cleared May 01, 2003
IMC-HEARTWAY MODEL HPS ELECTRIC POWERED WHEELCHAIR
K030432 · ITI
Imc-Heart Way LLC
Physical Medicine · 80d
Cleared May 01, 2003
STRATUSOCT WITH RNFL NORMATIVE DATABASE
K030433 · HLI
Carl Zeiss Meditec, Inc.
Ophthalmic · 80d
Cleared May 01, 2003
MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 8026 SERIES
K030733 · LPH
Zimmer, Inc.
Orthopedic · 52d