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
162097–162120 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 1981
TRIMETHOPRIM 5MCG. ANTIMICROBIAL DISK
K812783 · JTN
General Diagnostics
Microbiology · 18d
Cleared Oct 23, 1981
FERRITIN(125I) RADIOIMMUNOASSAY TEST SYS
K812786 · DBF
Corning Medical & Scientific
Immunology · 18d
Cleared Oct 23, 1981
TITERTEK AUTODROP
K812818 · JTC
Flow Laboratories, Inc.
Microbiology · 16d
Cleared Oct 23, 1981
FORMA CH/P GAS PROCESSOR
K812826 · JTQ
Forma Scientific, Inc.
Microbiology · 15d
Cleared Oct 23, 1981
MOXALACTAM 30MCG. SENSI-DISC
K812844 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 14d
Cleared Oct 23, 1981
ACCRA LAB HEMOTOLOGY
K812848 · IAF
Accra Laboratories, Inc.
Pathology · 14d
Cleared Oct 23, 1981
CHOLESTEROL CALIBRATORS
K812861 · JIS
Gilford Diagnostics
Chemistry · 10d
Cleared Oct 20, 1981
LYMPHA PRESS
K810338 · JOW
Mego Afek
Cardiovascular · 253d
Cleared Oct 20, 1981
EGNELL COMPACT, TYPE EHV
K812020 · BTA
Egnell, Inc.
General & Plastic Surgery · 92d
Cleared Oct 20, 1981
MODEL AP 180 MINI-MONITOR
K812256 · HGM
Sonicaid, Inc.
Obstetrics & Gynecology · 69d
Cleared Oct 20, 1981
STERILE TV CAMERA & CORD COVER
K812405 · KQM
Hydro-Med Products, Inc.
General & Plastic Surgery · 60d
Cleared Oct 20, 1981
X-RAY DETECTABLE LAP SPONGES
K812651 · GDY
Procter & Gamble Mfg. Co.
General & Plastic Surgery · 33d
Cleared Oct 20, 1981
REAGENTS FOR SERODIAGNOSIS OF ASPERGILL
K812740 · JWT
Nolan Biological Laboratories, Inc.
Microbiology · 21d
Cleared Oct 20, 1981
PHYSIOLOGICAL PRESSURE TRANSDUCER
K812758 · DRS
Electromedics, Inc.
Cardiovascular · 19d
Cleared Oct 20, 1981
IL 501, NA/K ANALYZER
K812762 · JGS
Instrumentation Laboratory CO
Chemistry · 19d
Cleared Oct 20, 1981
ECG MEDATAPE-601
K812763 · DSH
Hospital Equipment Service
Cardiovascular · 18d
Cleared Oct 20, 1981
BECKMAN ASTRA SYS. TOTAL BILIRUBIN MOD
K812784 · CIG
Beckman Instruments, Inc.
Chemistry · 15d
Cleared Oct 20, 1981
LIPASE
K812794 · CET
Pointe Scientific, Inc.,
Chemistry · 14d
Cleared Oct 20, 1981
ANAEROBIC BLOOD AGAR
K812795 · JSG
Isle Media and Sterile Products, Inc.
Microbiology · 14d
Cleared Oct 20, 1981
ANAEROBIC CNA BLOOD AGAR
K812796 · JSJ
Isle Media and Sterile Products, Inc.
Microbiology · 14d
Cleared Oct 20, 1981
SCHAEDLER AGARS
K812797 · JSG
Isle Media and Sterile Products, Inc.
Microbiology · 14d
Cleared Oct 20, 1981
MOTILITY GI MEDIUM
K812798 · JSG
Isle Media and Sterile Products, Inc.
Microbiology · 14d
Cleared Oct 20, 1981
DCATS
K812799 · IYM
Dorex, Inc.
Radiology · 14d
Cleared Oct 20, 1981
FLOW-DIRECTED THERMODILUTION CATHETER
K812800 · KRB
Sorensen Research
Cardiovascular · 14d