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
167353–167376 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 1980
TOTE-BRUSH
K800154 · EFW
Anja Marketing, Inc.
Dental · 13d
Cleared Feb 05, 1980
VIMEDIC SYSTEM TM
K800163 · EFA
Medical Systems Group of Viskay, Inc.
Dental · 11d
Cleared Feb 05, 1980
IMMUNOGLOBULIN M REAGENT SYSTEM
K800167 · DFT
Calbiochem-Behring Corp.
Immunology · 11d
Cleared Feb 05, 1980
SIROPORT
K800172 · KLC
Siemens Corp.
Dental · 11d
Cleared Feb 05, 1980
MEDTRONIC PISCES GENERATION II LEAD KIT
K800193 · GZB
Medtronic Vascular
Neurology · 7d
Cleared Feb 01, 1980
CONPHAR SURGICAL RAZORR
K791798 · LDQ
Conphar, Inc.
General & Plastic Surgery · 140d
Cleared Feb 01, 1980
MONOJECT PLASTIC DENTAL INJ. SYRINGE
K792541 · EJI
Sherwood Medical Co.
Dental · 53d
Cleared Feb 01, 1980
MICROPITETTE
K792696 · JRC
Meridian Diagnostics, Inc.
Chemistry · 36d
Cleared Feb 01, 1980
CORTEX DOUBLE HELIX SAMPLER
K800003 · GLE
Cortex Research Corp.
Hematology · 30d
Cleared Feb 01, 1980
DINAMAP RESEARCH MONITOR 1245
K800025 · DXN
Applied Medical Research
Cardiovascular · 25d
Cleared Feb 01, 1980
HANCOCK AORTIC PUNCH
K800122 · DWS
Hancock Laboratories, Inc.
Cardiovascular · 14d
Cleared Feb 01, 1980
CARDIOPLEGIA ADMINISTRATION SYSTEM CAS
K800135 · KRJ
Bentley Laboratories, Inc.
Cardiovascular · 11d
Cleared Feb 01, 1980
DIAGNOSTIC INTRAVASCULAR CATHETER
K800171 · DQO
Flomed, Inc.
Cardiovascular · 7d
Cleared Jan 31, 1980
PACING SYSTEM ANALYZER PSA SCE-22
K791975 · DTC
Ela Medical, Inc.
Cardiovascular · 121d
Cleared Jan 31, 1980
TELEMETRY SYSTEM XMT-1 & REC-1
K792371 · GYE
Burdick Corp.
Neurology · 66d
Cleared Jan 31, 1980
CYNERGY MODEL 182
K792536 · DTE
Cynergy
Cardiovascular · 55d
Cleared Jan 31, 1980
MINI-CEARS COMPUTER (MODEL 1)
K800001 · GWS
Bik Foundation, Inc.
Neurology · 29d
Cleared Jan 31, 1980
MICROTHIN-DI
K800026 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 24d
Cleared Jan 31, 1980
MICROTHIN-PI
K800027 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 24d
Cleared Jan 31, 1980
H-H FIFTH VENTRICLE
K800168 · JXG
Holter-Hausner Intl.
Neurology · 6d
Cleared Jan 29, 1980
M.P.I. LENS GLIDE
K792066 · KYB
J. Leon Bilby
Ophthalmic · 106d
Cleared Jan 29, 1980
COULTER COUNTER MODEL S PLUS
K792537 · GKL
Coulter Electronics, Inc.
Hematology · 50d
Cleared Jan 29, 1980
URIC ACID KIT
K792545 · KNK
Alta Diagnostics, Inc.
Chemistry · 50d
Cleared Jan 29, 1980
AGAROSE BARBITAL BUFFER
K792547 · JJN
Electrophoresis Corp. of America
Chemistry · 50d