FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cardiovascular ×
18,151 results
14857–14880 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 01, 1985
MODEL 486-03 POLY FLEX IMPLANTABLE PACING LEAD
K853411 · DTB
Intermedics, Inc.
Cardiovascular · 49d
Cleared Sep 30, 1985
BIO MEDICUS BIO PUMP MODEL BP-80
K852698 · KFM
Bio Medicus, Inc.
Cardiovascular · 96d
Cleared Sep 30, 1985
BCD PLUS BLOOD CARDIOPLEGIA SYS(HEREAF REFER DEV)
K852780 · DTR
Shiley, Inc.
Cardiovascular · 91d
Cleared Sep 30, 1985
BIO MEDICUS BIO PUMP MODEL BP-50
K852807 · KFM
Bio Medicus, Inc.
Cardiovascular · 90d
Cleared Sep 27, 1985
DUNN VESSEL OCCLUDER-STERILE
K851739 · DXC
Richard J. Turner Assoc.
Cardiovascular · 151d
Cleared Sep 25, 1985
CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR
K852382 · DTN
American Bentley
Cardiovascular · 112d
Cleared Sep 25, 1985
AMERICAN PHARMASEAL TRIPLE LUMEN CATHETER
K852491 · DQY
American Pharmaseal Div. Ahsc
Cardiovascular · 105d
Cleared Sep 25, 1985
CVERNE CAD DETECTOR
K852900 · DXG
Cherne Industries, Inc.
Cardiovascular · 78d
Cleared Sep 25, 1985
ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSION
K852914 · DQY
Norton Performance Plastics Corp.
Cardiovascular · 77d
Cleared Sep 25, 1985
COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT
K853100 · DYB
Cobe Laboratories, Inc.
Cardiovascular · 64d
Cleared Sep 23, 1985
METRONIC MODEL F7700 HEART VALVE SIZERS
K852612 · DTI
Medtronic Vascular
Cardiovascular · 96d
Cleared Sep 20, 1985
KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM
K852543 · DXK
Kontron Instruments, Inc.
Cardiovascular · 98d
Cleared Sep 19, 1985
FUKUDA DENSHI MODEL AU-5001-5003 THERMAL
K852487 · DSF
Fukuda Denshi USA, Inc.
Cardiovascular · 100d
Cleared Sep 18, 1985
NEWPORT VENTILATOR MODEL E-100
K852108
Newport Medical Instruments, Inc.
Cardiovascular · 126d
Cleared Sep 17, 1985
TELEFLEX GUIDEWIRE
K850677 · DQX
Teleflexmedical, Inc.
Cardiovascular · 208d
Cleared Sep 17, 1985
BARD-PARKER OCCLUSION BALLOON CATHETER
K852294 · DYG
Bd Becton Dickinson Vacutainer...
Cardiovascular · 111d
Cleared Sep 17, 1985
ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIP
K852446 · DTB
Diag Corp.
Cardiovascular · 99d
Cleared Sep 17, 1985
IMPLANT ELECT LEAD, MOD 30-403 USING POLYU 90 A
K852709 · DTB
Telectronics, Inc.
Cardiovascular · 83d
Cleared Sep 17, 1985
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD,#30-401
K853221 · DTB
Telectronics, Inc.
Cardiovascular · 47d
Cleared Sep 17, 1985
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-402
K853222 · DTB
Telectronics, Inc.
Cardiovascular · 47d
Cleared Sep 17, 1985
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-407
K853223 · DTB
Telectronics, Inc.
Cardiovascular · 47d
Cleared Sep 16, 1985
CARBOCONE
K851732 · DRX
Imtech Corp.
Cardiovascular · 144d
Cleared Sep 16, 1985
CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA
K851913 · LDF
Cordis Corp.
Cardiovascular · 138d
Cleared Sep 16, 1985
HEMATOCRIT-SATURATION MONITOR HSM-100
K852124 · DRY
American Bentley
Cardiovascular · 124d