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
94801–94824 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 1997
VIDAMED MODEDL 7600 RF GENERATOR
K965061 · GEI
Vidamed, Inc.
General & Plastic Surgery · 41d
Cleared Jan 28, 1997
DILATION CATHETER, BALLOON
K965067 · GBM
Boston Scientific Corp
Gastroenterology & Urology · 41d
Cleared Jan 28, 1997
SOLOS, CIDEO CAMERA REPLACEMENT CABLE, 800/900 SERIES
K970056 · GCJ
Woodbine Optical Corp.
General & Plastic Surgery · 21d
Cleared Jan 27, 1997
ECLIPSE 2000
K961560 · GEX
Cardiogenes
General & Plastic Surgery · 291d
Cleared Jan 27, 1997
COMPLEAT SURGICAL MASK
K962654 · FXX
Carl Parker Associates, Inc.
General Hospital · 203d
Cleared Jan 27, 1997
ANEROID AND MERCURIAL SPHYGMOMANOMETERS
K962655 · DXQ
American Diagnostic Corp.
Cardiovascular · 203d
Cleared Jan 27, 1997
HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO...
K962854 · LOS
Cardio Control BV
Cardiovascular · 189d
Cleared Jan 27, 1997
GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON
K963509 · LPH
Smith & Nephew Richards, Inc.
Orthopedic · 146d
Cleared Jan 27, 1997
THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE
K963675 · KKX
Micro-Medical Devices, Inc.
General Hospital · 136d
Cleared Jan 27, 1997
JOBST ATHROMBIC PUMP SYSTEM 2100
K963929 · JOW
Jobst A Beiersdorf Co.
Cardiovascular · 144d
Cleared Jan 27, 1997
OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION)
K963946 · LPH
Osteonics Corp.
Orthopedic · 117d
Cleared Jan 27, 1997
METAL BACKED ACETABULAR COMPONENT
K963998 · LPH
Encore Orthopedics, Inc.
Orthopedic · 112d
Cleared Jan 27, 1997
DG NERVUS
K964280 · GWQ
Medelec , Ltd.
Neurology · 91d
Cleared Jan 27, 1997
NATURAL-HIP SYSTEM COCR STEM
K964357 · LZO
Intermedics Orthopedics
Orthopedic · 87d
Cleared Jan 27, 1997
MODEL D-290P ADMINISTRATION SET
K964384 · FPA
Patient Solutions, Inc.
General Hospital · 84d
Cleared Jan 27, 1997
PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT
K964395 · LZO
Hayes Medical, Inc.
Orthopedic · 84d
Cleared Jan 27, 1997
LR 5200 LASER FILM RECORDER
K964414 · LMC
Bayer Corp., Agfa Div.
Radiology · 83d
Cleared Jan 27, 1997
AQUABOND ELECTRODE
K964433 · GXY
Medibond , Ltd.
Neurology · 83d
Cleared Jan 27, 1997
H.PYLORI CONTROLS
K964675 · LYR
Pyramid Biological Corp.
Microbiology · 67d
Cleared Jan 27, 1997
DYNAMOMETER
K964685 · LBB
John Chatillon & Sons, Inc.
Neurology · 66d
Cleared Jan 27, 1997
S.A.M. FACIAL IMPLANT W/INTRODUCER
K964761 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 61d
Cleared Jan 27, 1997
VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015)
K965048 · JJY
Johnson & Johnson Clinical...
Chemistry · 40d
Cleared Jan 27, 1997
DAHLBERG (A-554)
K965049 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 40d
Cleared Jan 27, 1997
AUDIOTONE (A554H)
K965057 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 40d