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
91753–91776 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 1997
RUSCH BRILLANT BALLOON CATHETER
K971643 · EZL
Rusch Intl.
Gastroenterology & Urology · 155d
Cleared Oct 07, 1997
BIPOLAR SCISSORS
K972558 · GEI
Enable Medical Corp.
General & Plastic Surgery · 90d
Cleared Oct 07, 1997
MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION...
K972678 · FRN
Mcgaw, Inc.
General Hospital · 83d
Cleared Oct 07, 1997
OPTA5 PTA BALLOON CATHETER, POWERFLEX PTA BALLOON CATHETER, ULTRA-THIN...
K972825 · FGE
Cordis Corp.
Gastroenterology & Urology · 90d
Cleared Oct 07, 1997
KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D)
K972847 · LMC
Eastman Kodak Company
Radiology · 67d
Cleared Oct 07, 1997
PLA-96P
K973086 · EJJ
Southern Dental Industries, Inc.
Dental · 50d
Cleared Oct 07, 1997
TOKUSO REBASE MR. BOND
K973245 · KLE
Tokuyama America, Inc.
Dental · 39d
Cleared Oct 07, 1997
PRECINORM RF, PRECIPATH RF
K973629 · JJY
Boehringer Mannheim Corp.
Immunology · 13d
Cleared Oct 06, 1997
REAADS PROTEIN C ANTIGEN TEST KIT
K972342 · GGP
Reaads Medical Products, Inc.
Hematology · 104d
Cleared Oct 06, 1997
NUVOLASE 660 LASER SYSTEM FOR OPHTHALMOLOGY
K972561 · GEX
American Laser Medical
General & Plastic Surgery · 89d
Cleared Oct 06, 1997
HOWMEDICA FULLY THREADED SCREWS
K972811 · HSB
Howmedica Corp.
Orthopedic · 70d
Cleared Oct 06, 1997
ACCUWELL T4-EIA
K972974 · KLI
Neometrics, Inc.
Chemistry · 56d
Cleared Oct 06, 1997
2487 DUAL WAVELENGTH ABSORBANCE DETECTOR
K973074 · KZR
Waters Corporation
Toxicology · 49d
Cleared Oct 06, 1997
TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN,...
K973126 · JHX
Biosite Incorporated
Chemistry · 47d
Cleared Oct 06, 1997
MYOGLOBIN CONTROL SET
K973358 · JJX
Boehringer Mannheim Corp.
Chemistry · 28d
Cleared Oct 06, 1997
ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
K973367 · CHL
Radiometer America, Inc.
Chemistry · 28d
Cleared Oct 06, 1997
CEFPODOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K973487 · JTN
Oxoid , Ltd.
Microbiology · 21d
Cleared Oct 03, 1997
GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM
K964617 · IYO
GE Medical Systems
Radiology · 340d
Cleared Oct 03, 1997
EXPERT-XL TOTAL BODY ACQUISITION AND ANALYSIS SOFTWARE
K965226 · KPS
Lunar Corp.
Radiology · 277d
Cleared Oct 03, 1997
HEWLETT APCKARD SERIES 50 OB TRACEVUE OBSTETRICAL SURVEILLANCE AND ARCHIVING...
K970456 · HGM
Hewlett-Packard GmbH
Obstetrics & Gynecology · 239d
Cleared Oct 03, 1997
NIVP3 (WINDOWS VERSION OF NIVP
K970570 · DQK
D. E. Hokanson, Inc.
Cardiovascular · 231d
Cleared Oct 03, 1997
MAGELLAN MAGNETIC DISTAL TARGETING SYSTEM(PROPOSED NAME), PRODUCT LINE EXTENSION
K971056 · HSB
Wrightmedicaltechnologyinc
Orthopedic · 193d
Cleared Oct 03, 1997
FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR
K971131 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 190d
Cleared Oct 03, 1997
BABYTHERM 8004 BABYTHERM 8010
K971198 · FMT
Drager, Inc.
General Hospital · 186d