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
94609–94632 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 21, 1997
FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTER
K963057 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 227d
Cleared Mar 21, 1997
METAGEN ALL POLY ACETABULAR CUP SYSTEM
K964003 · JDI
Metagen, LLC
Orthopedic · 165d
Cleared Mar 21, 1997
DECISION SUPPORT SYSTEM (FOR RADIATION ONCOLOGY)
K964167 · IYE
Multidata Systems International Corp.
Radiology · 156d
Cleared Mar 21, 1997
ELLIPSE 4
K964522 · FEN
Andromeda Medizinische Systeme GmbH
Gastroenterology & Urology · 129d
Cleared Mar 21, 1997
LIBERTY VALVE
K964690 · KNX
Cleveland Medical Devices, Inc.
Gastroenterology & Urology · 119d
Cleared Mar 21, 1997
ALLCLENZ WOUND CLEANSER
K965120 · KMF
Dpt Laboratories, Ltd.
General & Plastic Surgery · 88d
Cleared Mar 21, 1997
TRUFILL PVA PARTICLES
K965174 · HCG
Cordis Neurovascular, Inc.
Neurology · 87d
Cleared Mar 21, 1997
CES INFUSION CATHETER
K965181 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 87d
Cleared Mar 21, 1997
THERMAPREP PLUS OVEN
K970134 · EKM
Tulsa Dental Products, Ltd.
Dental · 65d
Cleared Mar 21, 1997
DEPUY ACE AIM TITANIUM TIBIAL NAIL
K970202 · HSB
Depuy Ace Medical Co.
Orthopedic · 59d
Cleared Mar 21, 1997
FEMTEX 100% COTTON DENTLE TOUCH TAMPONS
K970232 · HEB
Regu-Tech Assoc., Inc.
Obstetrics & Gynecology · 59d
Cleared Mar 21, 1997
SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE
K970247 · EOB
Smith & Nephew, Inc.
Ear, Nose, Throat · 58d
Cleared Mar 21, 1997
FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666
K970293 · LMD
Fujifilm Medical System U.S.A., Inc.
Radiology · 56d
Cleared Mar 21, 1997
ALGOPLAQUE HYDROCOLLOID DRESSING
K970518 · MGP
Laboratoires Urgo S.A.
General & Plastic Surgery · 38d
Cleared Mar 21, 1997
TUSTEX FLAVORED CONDOMS
K970633 · HIS
Line One Laboratories
Obstetrics & Gynecology · 29d
Cleared Mar 21, 1997
PHILIPS EASY DIAGNOST
K970640 · IXR
Philips Medical Systems North...
Radiology · 29d
Cleared Mar 21, 1997
ACRYDERM GEL WOUND DRESSING
K970693 · MGQ
Acrymed, Inc.
General & Plastic Surgery · 24d
Cleared Mar 21, 1997
DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM
K970721 · MCY
Johnson & Johnson Medical, Inc.
General & Plastic Surgery · 22d
Cleared Mar 20, 1997
POWERED WHEELCHAIR
K962565 · ITI
Orthofab, Inc.
Physical Medicine · 262d
Cleared Mar 20, 1997
CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4
K963698 · DTY
International Biophysics Corp.
Cardiovascular · 185d
Cleared Mar 20, 1997
SURE CORE BIOPSY KIT
K963813 · KNW
Interventional Concepts, Inc.
Gastroenterology & Urology · 178d
Cleared Mar 20, 1997
CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680
K964336 · GEH
Cryomedical Sciences, Inc.
General & Plastic Surgery · 140d
Cleared Mar 20, 1997
IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT
K964877 · DYF
Impra, Inc.
Cardiovascular · 105d
Cleared Mar 20, 1997
SUPERLIGHT
K964954 · INI
Wheelcare Scooters, Inc.
Physical Medicine · 99d