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
93217–93240 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 04, 1997
RADIONICS BURR HOLE VALVE
K970578 · JXG
Radionics, Inc.
Neurology · 110d
Cleared Jun 04, 1997
ISG FAMILY OF VIEWING WANDS
K970865 · HAW
I.S.G. Technologies, Inc.
Neurology · 86d
Cleared Jun 04, 1997
SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT
K970905 · CHI
Beckman Instruments, Inc.
Chemistry · 84d
Cleared Jun 04, 1997
TAMARYN I.V. FLOW REGULATOR EXTENSION SET
K971066 · FPA
Tamaryn Medical Systems, Inc.
General Hospital · 72d
Cleared Jun 04, 1997
GREINER VACUETTE BLOOD COLLECTION TUBE
K971220 · JKA
Greiner America, Inc.
Chemistry · 63d
Cleared Jun 04, 1997
SERIES XE, SERIES SE, SERIES TE
K971350 · EGS
Micro-Mega Societe Anonyme
Dental · 55d
Cleared Jun 04, 1997
DERMACLEAN X-AM (PROTEIN LABELING CLAIM) EXAMINATION GLOVES
K971424 · LYY
Ansell Perry
General Hospital · 47d
Cleared Jun 04, 1997
NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS
K971465 · HOY
National Healthcare Mfg. Corp.
General Hospital · 43d
Cleared Jun 04, 1997
DUQIAO
K971551 · HQY
Duqiao Glasses (Group) Co. , Ltd.
Ophthalmic · 37d