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
168409–168432 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 1979
TRYPTIC SOY BROTH
K791623 · JSC
American Laboratory Supply, Inc.
Microbiology · 37d
Cleared Sep 27, 1979
MYCOBIOTIC AGAR
K791626 · JSJ
Isle Media and Sterile Products, Inc.
Microbiology · 37d
Cleared Sep 27, 1979
MANNITOL SALT AGAR
K791627 · JSI
Isle Media and Sterile Products, Inc.
Microbiology · 37d
Cleared Sep 27, 1979
BRAIN HEART INFUSION AGAR 5% SHEEP BLOOD
K791628 · JSG
Isle Media and Sterile Products, Inc.
Microbiology · 37d
Cleared Sep 27, 1979
BRAIN HEART CC AGAR
K791629 · JSJ
Isle Media and Sterile Products, Inc.
Microbiology · 37d
Cleared Sep 27, 1979
BRAIN HEART INFUSION AGAR
K791630 · JSG
Isle Media and Sterile Products, Inc.
Microbiology · 37d
Cleared Sep 27, 1979
SABOURAUD DEXTROSE AGAR
K791631 · JSG
Isle Media and Sterile Products, Inc.
Microbiology · 37d
Cleared Sep 27, 1979
TOTAL ESTROGENS KIT BY RIA
K791651 · JMD
Radioassay Systems Laboratories, Inc.
Chemistry · 37d
Cleared Sep 27, 1979
ESTRADIOL KIT BY RIA
K791652 · CHP
Radioassay Systems Laboratories, Inc.
Chemistry · 37d
Cleared Sep 27, 1979
IMMUCHEM COVALENT COAT BINDING
K791662 · KHQ
Immuchem Corp.
Chemistry · 37d
Cleared Sep 27, 1979
IMMUCHEM COVALENT COAT SOLID PHASE ASSAY
K791664 · CDX
Immuchem Corp.
Chemistry · 37d
Cleared Sep 27, 1979
ARCOLITH 2000
K791715 · DXY
Arco Medical Products Co.
Cardiovascular · 27d
Cleared Sep 27, 1979
IMPLANTABLE VENTRICULAR-INHIBITED
K791727 · DXY
Telectronics, Inc.
Cardiovascular · 27d
Cleared Sep 27, 1979
RSL'S ASSAY PROCEDURE QUANTITATION
K791728 · CGI
Radioassay Systems Laboratories, Inc.
Chemistry · 28d
Cleared Sep 27, 1979
SERUM 11-DESOXYCORTISOL I AS TRACER
K791740 · JKB
Radioassay Systems Laboratories, Inc.
Chemistry · 17d
Cleared Sep 27, 1979
URIC ACID REAGENT
K791754 · KNK
Gilford Diagnostics
Chemistry · 22d
Cleared Sep 27, 1979
GLUCOSE HEXOKINASE COIL REAGENT SYSTEM
K791760 · CFR
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Sep 27, 1979
COMP-ACT IV
K791795 · DPS
Medcraft Corp.
Cardiovascular · 13d
Cleared Sep 27, 1979
BJORK-SHILEY PULMONIC GRAFT VALVE
K791828 · DSY
Shiley, Inc.
Cardiovascular · 10d
Cleared Sep 27, 1979
CORALENT COAT 125I CORTISOL RADIOIMM.
K791835 · CGR
Radioassay Systems Laboratories, Inc.
Chemistry · 10d
Cleared Sep 26, 1979
WECK RACK (STERILIZING ACCESSORY TRAY)
K791743 · FSM
Edward Weck, Inc.
General & Plastic Surgery · 16d
Cleared Sep 26, 1979
EDWARDS PACEMAKER 30 UNIPOLAR GENERATOR
K791751 · DXY
Edwards Pacemaker Systems
Cardiovascular · 21d
Cleared Sep 26, 1979
AIR INCENTIVE SPIROMETER
K791819 · BWF
Airlife, Inc.
Anesthesiology · 12d
Cleared Sep 26, 1979
I.P.P.B. MANIFOLDS & NEB. SING. & DBL
K791820 · CAF
Airlife, Inc.
Anesthesiology · 12d