FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
71689–71712 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 2003
HIVOX DREAMATE DM-800
K021952 · GZJ
Hivox Biotek, Inc.
Neurology · 323d
Cleared May 02, 2003
CARECOMPANION PATIENT STATION/CARECOMPANION PATIENT STATION
K023286 · DXN
Neptec Design Group, Ltd.
Cardiovascular · 212d
Cleared May 02, 2003
GLYCA-DIRECT FRUCTOSAMINE
K023654 · LCP
Polymedco, Inc.
Chemistry · 184d
Cleared May 02, 2003
AIRLIFE DEMAND NASAL CANNULA
K023673 · NFB
Allegiance Healthcare Corp.
Anesthesiology · 182d
Cleared May 02, 2003
BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION
K024289 · MRC
Bausch & Lomb, Incorporated
Ophthalmic · 130d
Cleared May 02, 2003
REPROCESSED ELECTROPHYSIOLOGY CATHETER
K030026 · NLH
Alliance Medical Corp.
Cardiovascular · 119d
Cleared May 02, 2003
NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735
K030207 · LZA
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 101d
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