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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
157945–157968 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 14, 1983
COMPUTED CINETOMOGRAPHY SCANNER, MODEL C-100
K828669
Imatron, Inc.
Radiology · 45d
Cleared Jan 14, 1983
A.V. FISTULA CANNULATION SETS
K830021 · KOC
Travenol Laboratories, S.A.
Gastroenterology & Urology · 10d
Cleared Jan 14, 1983
FIBERSCOPE DISINFECTANT IRRIGATOR
K830026 · FEB
Keymed, Inc.
General Hospital · 10d
Cleared Jan 12, 1983
GORE-TES EXPANDED PTFE PATCH
K821717 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 216d
Cleared Jan 12, 1983
BOUNDARY SINGLE-USE GOWNS
K822925 · FYA
The Buckeye Cellulose Corp.
General Hospital · 103d
Cleared Jan 12, 1983
ENGSTROM ELIZA CO2 ANALYZER
K823049 · CCK
Lkb Instruments, Inc.
Anesthesiology · 89d
Cleared Jan 12, 1983
DRAPE, SURGICAL ANGIOGRAPHY
K823054 · KKX
Triad Medical Division
General Hospital · 86d
Cleared Jan 12, 1983
SATOBAN FIRST AID TAPE
K823076 · KGX
Food and Drug Service, Inc.
General & Plastic Surgery · 85d
Cleared Jan 12, 1983
DOSIMETRIC RELEASE PROGRAM - ADMIN. SET
K823214 · FPA
Cutter Laboratories, Inc.
Chemistry · 76d
Cleared Jan 12, 1983
ACCA-TEMP SKIN TEMP. VINYL DISC
K823221 · KPD
T. G. & E. Medical
General Hospital · 75d
Cleared Jan 12, 1983
THYROXINE ANALYSIS PRODUCTS/RADIO-FREE
K823264 · CEC
Bd Becton Dickinson Vacutainer...
Chemistry · 71d
Cleared Jan 12, 1983
MODEL 400 & 700 TEMP. SENSOR ADAPTERS
K823333 · FLL
Mon-A-Therm, Inc.
General Hospital · 65d
Cleared Jan 12, 1983
EEG & RESPIRATION MODULES POLYGRAPH
K823563 · BZQ
Nihon Kohden America, Inc.
Anesthesiology · 41d
Cleared Jan 12, 1983
POLY-TONE DENTURE BASE RESIN
K823568 · EBI
General Dental Products, Inc.
Dental · 40d
Cleared Jan 12, 1983
E.S. PENCIL
K823670 · GEI
Surgicare Scientific Laboratory, Inc.
General & Plastic Surgery · 36d
Cleared Jan 12, 1983
3M SCOTCHPLATE 51148 SMALL CONDUCTIVE
K823689 · GEI
3M Company
General & Plastic Surgery · 36d
Cleared Jan 12, 1983
MADE-TO-MEASURE SURGICAL ELASTIC SUPPORT
K823737 · DWL
Gotfried Medical, Inc.
General Hospital · 30d
Cleared Jan 12, 1983
ADVANCE SYS. EMIT-AED ANTIEPILEPTIC DRUG
K823746 · DIF
Syva Co.
Chemistry · 30d
Cleared Jan 12, 1983
SOPHEIA THYROXINE EIA KIT
K823751 · KLI
Diagnostic Products Corp.
Chemistry · 29d
Cleared Jan 12, 1983
ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082
K823756 · CIC
Em Industries, Inc.
Chemistry · 29d
Cleared Jan 12, 1983
VARIOUS-ANALYZER CUPS
K823762 · JJE
Cordis Corp.
Chemistry · 29d
Cleared Jan 12, 1983
LUNDIA 10-5-L PARRALLE FLOW DIALYZER
K823791 · KOC
Gambro, Inc.
Gastroenterology & Urology · 27d
Cleared Jan 12, 1983
CAPILLARY FLOW DIALYZERS
K823826 · KOC
Travenol Laboratories, S.A.
Gastroenterology & Urology · 23d
Cleared Jan 12, 1983
INFUSE-A-PORT
K823838 · LJT
Infusaid Corp.
General Hospital · 15d