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
156001–156024 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 11, 1983
MAGIC TM 125I T3 UPTAKE RADIOASSAY
K831613 · KHQ
Corning Medical & Scientific
Chemistry · 84d
Cleared Aug 11, 1983
MORHEL CLOSED URINARY DRAINAGE SET
K831622 · KNX
Morhel Mexicana
Gastroenterology & Urology · 83d
Cleared Aug 11, 1983
READER MICROELISA SYSTEM
K831641 · LIB
Organon Teknika Corp.
Chemistry · 80d
Cleared Aug 11, 1983
EMPTY DIALYSATE CONTAINER
K831689 · FKK
Delmed, Inc.
Gastroenterology & Urology · 79d
Cleared Aug 11, 1983
DISPOSABLE PRESSURE TRANSDUCER#14004195
K831698 · DRS
Norton Performance Plastics Corp.
Cardiovascular · 78d
Cleared Aug 11, 1983
EYE MUSCLE SLEEVES
K831726 · FTM
S. Jackson, Inc.
General & Plastic Surgery · 72d
Cleared Aug 11, 1983
PISCES #3487 EPIDURAL LEAD FOR SPINAL
K831746 · GZB
Medtronic Vascular
Neurology · 71d
Cleared Aug 11, 1983
UCG-BETA SLIDE MONOCLONAL
K831775 · JHJ
Armkel, LLC
Chemistry · 70d
Cleared Aug 11, 1983
DENTAL ELECTRONIC/S.B.R TRADING BU HAND
K831824 · EAY
Silverman'S
Dental · 65d
Cleared Aug 11, 1983
FETAL MONITOR #115
K831852 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 63d
Cleared Aug 11, 1983
SURGITEK PERCUTANEOUS ARNEGRADE SILITEK
K831857 · FAD
Medical Engineering Corp.
Gastroenterology & Urology · 63d
Cleared Aug 11, 1983
ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS
K831924 · LKT
Electro-Nucleonics Laboratories, Inc.
Microbiology · 57d
Cleared Aug 11, 1983
HR 100T
K831955 · JOM
Thought Technology , Ltd.
Cardiovascular · 55d
Cleared Aug 11, 1983
IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN
K831961 · JBQ
Kent Laboratories, Inc.
Chemistry · 55d
Cleared Aug 11, 1983
CMS 2000 SERIES TPN KITS
K831964 · FMC
Currie Medical Specialties, Inc.
General Hospital · 55d
Cleared Aug 11, 1983
CARDIOPLEGIA RESERVOIR-#500926
K831966 · DTN
American Bentley
Cardiovascular · 52d
Cleared Aug 11, 1983
EMIT SERUM TRICYCLIC ANTIDEPRESSENT
K831978 · LFG
Syva Co.
Chemistry · 52d
Cleared Aug 11, 1983
WAKO CPK TEST
K832004 · JHY
Wako Chemicals USA, Inc.
Chemistry · 50d
Cleared Aug 11, 1983
PENTAX FG-34JA GASTROFIBERSCOPE
K832007 · FDS
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 49d
Cleared Aug 11, 1983
ANTI-N DNA ANTIBODY TEST KIT
K832031 · KTL
Breit Laboratories, Inc.
Immunology · 49d
Cleared Aug 11, 1983
SERALYZER MULTICOMPONENT CALIBRATORS
K832046 · JIX
Miles Laboratories, Inc.
Chemistry · 48d
Cleared Aug 11, 1983
TOTAL CO2 REAGENT SET
K832071 · CIE
American Research Products Co.
Chemistry · 45d
Cleared Aug 11, 1983
BILIRUBIN CALIBRATORS & CONTROL
K832094 · JIT
Gilford Diagnostics
Chemistry · 44d
Cleared Aug 11, 1983
PHENOBARTIAL ASSAY USE ON COBAS-BIO
K832097 · DLZ
Syva Co.
Chemistry · 43d