FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
95281–95304 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 1997
DISETRONIC D-MODEM
K961975 · FRN
Disetronic Medical Systems
General Hospital · 255d
Cleared Jan 30, 1997
COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER
K962288 · MMP
Pinnacle Products, Inc.
General Hospital · 230d
Cleared Jan 30, 1997
DEXTREN CLEAR POWDER-FREE HYPOALLERGENIC SURGICAL GLOVES
K962813 · KGO
Maxxim Medical
General Hospital · 195d
Cleared Jan 30, 1997
SPECIALTY T TORIC (OCUFILCON A) CONTACT LENS FOR DAILY WEAR
K963764 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 133d
Cleared Jan 30, 1997
CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS
K964041 · KOC
Robert R. Stevens
Gastroenterology & Urology · 114d
Cleared Jan 30, 1997
GE STERILE DISPOSABLE EQUIPMENT COIL COVER
K964141 · MOS
Contour Fabricators, Inc.
Radiology · 107d
Cleared Jan 30, 1997
BIPAP DUET SYSTEM
K964363 · BZD
Respironics, Inc.
Anesthesiology · 90d
Cleared Jan 30, 1997
CES VASCULAR OCCLUSION SYSTEM
K964367 · HCG
Cordis Neurovascular, Inc.
Neurology · 90d
Cleared Jan 30, 1997
WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEM
K964436 · HET
Western Surgical Instrument Co.
Obstetrics & Gynecology · 86d
Cleared Jan 30, 1997
OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)
K964445 · DWS
Dlp, Inc.
Cardiovascular · 85d
Cleared Jan 30, 1997
POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333
K964455 · FPA
Medtronic Minimed
General Hospital · 85d
Cleared Jan 30, 1997
POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 367
K964456 · FPA
Medtronic Minimed
General Hospital · 85d
Cleared Jan 30, 1997
CW ACUPUNCTURE NEEDLES
K964529 · MQX
Lhasa Medical, Inc.
General Hospital · 79d
Cleared Jan 30, 1997
VISTAKON (GENFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILIITY TINT
K964612 · LPL
Vistakon, Johnson & Johnson Vision...
Ophthalmic · 73d
Cleared Jan 30, 1997
ELECTROPHYSIOLOGY TILT TABLE MODEL #9660
K965105 · IXR
U.S. Imaging Tables, Inc.
Radiology · 41d
Cleared Jan 30, 1997
VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3...
K970016 · CDP
Johnson & Johnson Clinical...
Chemistry · 28d
Cleared Jan 30, 1997
ELECSYS CALCHECK TESTOSTERONE
K970146 · JJX
Boehringer Mannheim Corp.
Chemistry · 15d
Cleared Jan 29, 1997
PILOT MODEL 9200 BLOOD PRESSURE MEASUREMENT SYSTEM
K922668 · MHX
Colin Medical Instruments Corp.
Cardiovascular · 1700d
Cleared Jan 29, 1997
PATHFINDER
K955802 · DRF
Cardima, Inc.
Cardiovascular · 404d
Cleared Jan 29, 1997
GYRO TIP EP CATHETER
K955847 · DRF
Cardiac Assist Devices, Inc.
Cardiovascular · 400d
Cleared Jan 29, 1997
PH ANALYSIS MODULE
K961346 · FFT
Synectics-Dantec
Gastroenterology & Urology · 320d
Cleared Jan 29, 1997
WILSON-COOK BILIARY INTRODUCER WITH ASPIRATION BIOPSY NEEDLE
K961897 · FCG
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 258d
Cleared Jan 29, 1997
SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
K962291 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 229d
Cleared Jan 29, 1997
EAGLE EYES
K964366 · HQY
Mech-Tronic Precision Mfg., Ltd.
Ophthalmic · 89d