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
166249–166272 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 1980
ALIZARIN SULFONATE, CALCIUM
K801290 · CID
Union Carbide Corp.
Chemistry · 31d
Cleared Jun 30, 1980
COBAS REAGENT FOR CHOLESTEROL
K801296 · CHH
Roche Analytical Instruments, Inc.
Chemistry · 28d
Cleared Jun 30, 1980
COBAS REAGENT FOR GLUCOSE RAPID
K801297 · CFR
Roche Analytical Instruments, Inc.
Chemistry · 28d
Cleared Jun 30, 1980
PACKAGE FOR MEDI-TRACE PHYSIOLOGICAL PRE
K801321 · DQO
Graphic Controls Corp.
Cardiovascular · 25d
Cleared Jun 30, 1980
MEDI-TRACE DISP. LINES FOR PHYSIO. PRESS
K801322 · DQO
Graphic Controls Corp.
Cardiovascular · 25d
Cleared Jun 30, 1980
CLINICAL AUDIOMETER MODEL TA-200
K801325 · EWO
Teledyne Avionics Div. of Teledyne
Ear, Nose, Throat · 27d
Cleared Jun 30, 1980
PARKE-DAVIS SURGICAL LIGHT
K801353 · FTD
Warner-Lambert Co.
General & Plastic Surgery · 21d
Cleared Jun 30, 1980
COMPLEMENT C4 NEPHELOMETRIC ASSAY
K801361 · DBI
J.T. Baker Chemical Co.
Immunology · 21d
Cleared Jun 30, 1980
COMPLEMENT C3 NEPHELOMETRIC ASSAY
K801363 · CZW
J.T. Baker Chemical Co.
Immunology · 21d
Cleared Jun 30, 1980
DISPOSABLE SUMP SETS
K801392 · DWF
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
AIR ASPIRATOR NEEDLE
K801393 · DWS
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
CARDIOPULMONARY BYPASS PUMP TUBING
K801394 · DWE
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
VASCULAR CLAMP
K801395 · DXC
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
SAPHENOUS VEIN CANNULAE
K801396 · DWF
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
VENA CAVA CANNULAE
K801397 · DWF
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
AORTIC AND FEMORAL PERFUSION CANNULAE
K801398 · DWF
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
CORONARY PERFUSION CONNECTOR PLUG
K801399 · DTL
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
DISPOSABLE SUCKER SYSTEM
K801400 · DTS
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
CARDIOPULMONARY BYPASS TUBING
K801401 · DWF
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
QUICKIE PRIME CARDIOP. BYPASS PERF. INTR
K801402 · DTL
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
DISPOSABLE PERFUSION SET
K801403 · DWF
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
DISPOSABLE PARALLEL Y CONNECTORS
K801404 · DTL
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 30, 1980
DISPOSABLE PERFUSION CONNECTORS
K801405 · DTL
Texas Medical Products, Inc.
Cardiovascular · 17d
Cleared Jun 26, 1980
MEDTRONIC MODELS 5966/5967, ETC.
K800069 · DXY
Medtronic Vascular
Cardiovascular · 167d