Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
167089–167112 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 1980
UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN.
K801241 · DXY
Arco Medical Products Co.
Cardiovascular · 34d
Cleared Jun 30, 1980
J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA
K801282 · DFT
J.T. Baker Chemical Co.
Immunology · 32d
Cleared Jun 30, 1980
J.T. BAKER IMMUNO. A NEPHELOMETRIC ASSAY
K801283 · CZP
J.T. Baker Chemical Co.
Immunology · 32d
Cleared Jun 30, 1980
EMIT AAII THYROXINE CALIBRATORS
K801287 · JIS
Syva Co.
Chemistry · 31d
Cleared Jun 30, 1980
EMIT AAII THYROXINE ASSAY
K801288 · KLI
Syva Co.
Chemistry · 31d
Cleared Jun 30, 1980
LEECO GLYCO-HEMOGLOBIN DIAG. TEST KIT
K801289 · LCP
Leeco Diagnostics, Inc.
Hematology · 31d
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