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
159121–159144 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 08, 1982
CHIROPRATIC INFRA-RED CRYSTAL PAK
K821524 · KYA
Dr. John D. Reid B.A., D.C.
Radiology · 110d
Cleared Sep 07, 1982
DUODERM FLEXIBLE HYDROACTIVE DRESSINGS
K821656 · FRO
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 95d
Cleared Sep 07, 1982
TROPIC AIR HEAT-ECHANGER BREATHING AID
K821735 · BZE
Tropic Air
Anesthesiology · 85d
Cleared Sep 07, 1982
ANESTHESIA & BRAIN MONITOR
K821910 · IKN
Datex Division Instrumentarium Corp.
Neurology · 71d
Cleared Sep 07, 1982
NARKOMED 2A ANESTHESIA MACHINE
K822218 · BSZ
Draeger Medical, Inc.
Anesthesiology · 43d
Cleared Sep 07, 1982
IL 301 TRANSCUTANEOUS OXYGEN MONITOR
K822328 · KLK
Instrumentation Laboratory CO
Anesthesiology · 35d
Cleared Sep 07, 1982
TYTAN TUBE INSERTER
K822348 · JYM
Treace Medical, Inc.
Ear, Nose, Throat · 32d
Cleared Sep 07, 1982
TOTAL
K822367 · LBN
Treace Medical, Inc.
Ear, Nose, Throat · 32d
Cleared Sep 07, 1982
THE OCUPLOT D
K822415 · HPJ
Coherent Medical Division
Ophthalmic · 27d
Cleared Sep 07, 1982
AURAFILL* DENTAL RESTORATIVE BONDING AG.
K822451 · KLE
Johnson & Johnson Professionals, Inc.
Dental · 22d
Cleared Sep 07, 1982
HEARING AID, UNITRON UE3-D/DN
K822506 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 19d
Cleared Sep 07, 1982
VIVONEX MASS GASTRASTOMY TUBE
K822516 · KHT
Norwich Eaton Pharmaceuticals, Inc.
Immunology · 18d
Cleared Sep 02, 1982
CONTROL DIAGNOSTICS PLATELET CONTROL
K821851 · KRY
Immunogenetics
Chemistry · 71d
Cleared Sep 02, 1982
HCG BETA RIA KIT
K822152 · JHI
Clinetics Corp.
Chemistry · 41d
Cleared Sep 02, 1982
NEPHROSOL
K822244 · KOC
Dialysis Systems, Inc.
Gastroenterology & Urology · 37d
Cleared Sep 02, 1982
TRACHEAL DILATORS
K822260 · KCG
Kelleher Corp.
Ear, Nose, Throat · 35d
Cleared Sep 02, 1982
DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI
K822298 · JFH
Nuclear Medical Laboratories, Inc.
Chemistry · 30d
Cleared Sep 02, 1982
ULTRACHEM BUN-UV, 65080 & 65081
K822323 · CDW
Harleco Diagnostics
Chemistry · 30d
Cleared Sep 02, 1982
ANTITUBERCULOUS DRUGS (SIRE)
K822329 · JTT
Bd Becton Dickinson Vacutainer...
Microbiology · 30d
Cleared Sep 02, 1982
BACTEC DILUTING FLUID
K822330 · JSD
Bd Becton Dickinson Vacutainer...
Microbiology · 30d
Cleared Sep 02, 1982
BILIRUBIN CALIBRATORS
K822334 · JIT
Gilford Diagnostics
Chemistry · 29d
Cleared Sep 02, 1982
B-HCG
K822343 · JHI
Diagnostic Products Corp.
Chemistry · 28d
Cleared Sep 02, 1982
TYTAN GROMMET VENT TUBE, .040
K822366 · ETD
Treace Medical, Inc.
Ear, Nose, Throat · 27d
Cleared Sep 02, 1982
BASIC CENTRIFUGE
K822422 · JQC
Biodynamics Corp.
Hematology · 21d