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
93721–93744 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 1997
RIONET HB-79P
K971693 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 30d
Cleared Jun 06, 1997
CONTINU-FLO SOLUTION SET
K971701 · FPA
Baxter Healthcare Corp
General Hospital · 29d
Cleared Jun 06, 1997
PHILIPS S1694, S1695
K971804 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 23d
Cleared Jun 05, 1997
ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM
K963064 · FFX
Laborie Medical Tech Corp.
Gastroenterology & Urology · 302d
Cleared Jun 05, 1997
GORE IRRIGATION SET
K964067 · FPA
W.L. Gore & Associates, Inc.
General Hospital · 238d
Cleared Jun 05, 1997
STRAIGHTFIRE REUSABLE OPTICAL FIBERS (400,600,800,1000)
K965180 · GEX
Myriad Lase, Inc.
General & Plastic Surgery · 163d
Cleared Jun 05, 1997
LAMIN-2 HYDRATING GEL
K970153 · MGQ
Procyte Corp.
General & Plastic Surgery · 140d
Cleared Jun 05, 1997
GLARE WARE
K970816 · HQY
Ergovision, Inc.
Ophthalmic · 91d
Cleared Jun 05, 1997
INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
K970843 · DSY
Intervascular, Inc.
Cardiovascular · 90d
Cleared Jun 05, 1997
22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD
K970846 · LZO
Landos, Inc.
Orthopedic · 90d
Cleared Jun 05, 1997
MAGNETOM PROJECT 024 SYSTEM (NUMARIS 3.5 SOFTWARE)
K970852 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Jun 05, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS5169
K971099 · HGM
Alexander Mfg. Co.
Obstetrics & Gynecology · 71d
Cleared Jun 05, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER STR5
K971107 · BTA
Alexander Mfg. Co.
General & Plastic Surgery · 71d
Cleared Jun 05, 1997
MAGELLAN INTRAMEDULLARY FEMORAL NAIL SYSTEM
K971135 · HSB
Wrightmedicaltechnologyinc
Orthopedic · 70d
Cleared Jun 05, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625-W
K971235 · DQA
Alexander Mfg. Co.
Anesthesiology · 64d
Cleared Jun 05, 1997
TRAUMA-FIX EXTERNAL FIXATOR
K971272 · KTW
Trend Medical, Inc.
Orthopedic · 62d
Cleared Jun 04, 1997
BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS
K963018 · CEF
Bio-Rad
Chemistry · 306d
Cleared Jun 04, 1997
PARAMAX CHOLESTEROL REAGENT
K964660 · CHH
Dade Intl., Inc.
Chemistry · 196d
Cleared Jun 04, 1997
SIEMENS SC9000/SC9015 MULTIGAS AND MULTIGAS+ MODULES
K965062 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 168d
Cleared Jun 04, 1997
FOGARTY VALVULOTOME MODEL 700091
K965137 · MGZ
Baxter Edwards
Cardiovascular · 163d
Cleared Jun 04, 1997
TRI AUTO ZX
K970339 · EKX
J. Morita USA, Inc.
Dental · 126d
Cleared Jun 04, 1997
ACS ESTADIOL-6 II
K970386 · CHP
Chiron Diagnostics Corp.
Chemistry · 121d
Cleared Jun 04, 1997
PACE 101H
K970497 · DTE
Sulzer Oscor, Inc.
Cardiovascular · 114d
Cleared Jun 04, 1997
HILUX 200,250,275,300,350,500 DENTAL CURING LIGHT
K970506 · EBZ
Benlioglu Dental Ithalat, Inc.
Dental · 114d