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
94777–94800 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 29, 1997
KSEA PUNCTURE CANNULA
K964379 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 86d
Cleared Jan 29, 1997
SUNGLASSES
K964564 · HQY
Micron Metal & Plastic Manufactory Co.
Ophthalmic · 76d
Cleared Jan 29, 1997
SENNA
K964744 · HQY
Trans-America Enterprises Corp.
Ophthalmic · 64d
Cleared Jan 28, 1997
COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH MODIFIED PLASMA RECOVERY...
K962689 · CAC
Cobe Cardiovascular, Inc.
Anesthesiology · 201d
Cleared Jan 28, 1997
SOF. PRESS EPC 51 SYSTEM
K963067 · JOW
Gaymar Industries, Inc.
Cardiovascular · 174d
Cleared Jan 28, 1997
TORQUE DEVICE
K964352 · DQX
B.Braun Medical, Inc.
Cardiovascular · 88d
Cleared Jan 28, 1997
DALE ENDOTRACHEAL TUBE HOLDER 270/280
K964399 · CBH
Dale Medical Products, Inc.
Anesthesiology · 85d
Cleared Jan 28, 1997
TRANSEND GUIDEWIRE
K964611 · DQX
Boston Scientific Corp
Cardiovascular · 71d
Cleared Jan 28, 1997
EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM
K964919 · HRX
Emerald Medical, Inc.
Orthopedic · 50d