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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,053 results
15289–15312 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 19, 1984
THERMAL GRAYSCALE RF-100
K843836 · DSF
Fukuda Denshi USA, Inc.
Cardiovascular · 18d
Cleared Oct 18, 1984
PEDIATRIC DIAG. CRITERIA OPTION 5600C
K841416 · DSI
Hewlett-Packard Co.
Cardiovascular · 196d
Cleared Oct 18, 1984
ELECTRODE CATHETER, ORTHOGONAL TYPE
K841802 · LDF
Webster Laboratories, Inc.
Cardiovascular · 170d
Cleared Oct 18, 1984
AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE
K842481 · LYK
American Edwards Laboratories
Cardiovascular · 115d
Cleared Oct 18, 1984
SPACELABS ALPHA PC PATIENT COMPUTER
K842616 · DSI
Spacelabs, Inc.
Cardiovascular · 105d
Cleared Oct 18, 1984
LIFEPAK 8
K842624 · LDD
Physio-Control Corp.
Cardiovascular · 105d
Cleared Oct 18, 1984
HIGH PRESSURE, 1 & 3 WAY STERILE DISPOS
K842829 · DTL
North American Instrument Corp.
Cardiovascular · 90d
Cleared Oct 18, 1984
LIFEPAK 200
K843229 · LDD
Physio-Control Corp.
Cardiovascular · 62d
Cleared Oct 18, 1984
ARRHYTHMIA CENTRAL OCC-7101
K843287 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 58d
Cleared Oct 18, 1984
FLOW-DIRECTED THERMODILUTION CATH
K843409 · DYG
Andover Medical, Inc.
Cardiovascular · 48d
Cleared Oct 18, 1984
THERMAL DILUTION CATHETER
K843411 · DYG
Andover Medical, Inc.
Cardiovascular · 48d
Cleared Oct 18, 1984
ARGYLE SILICONE LEFT VENTRICULAR AND
K843444 · DWF
Sherwood Medical Co.
Cardiovascular · 43d
Cleared Oct 18, 1984
FRENCH 7 TRI-ACCESS COMPACT CENTRAL VEIN
K843500 · DYB
Cardio-Vascular Innovations, Inc.
Cardiovascular · 42d
Cleared Oct 18, 1984
PO 2 LYTRODE
K843538 · DRY
Polystan C/O Vitalcor, Inc.
Cardiovascular · 41d
Cleared Oct 18, 1984
SHILEY CORONARY CARDIOPLEGIA ADAPTOR
K843542 · DWF
Shiley, Inc.
Cardiovascular · 41d
Cleared Oct 18, 1984
SINGLE WALL INTRODUCER NEEDLE
K843719 · DYB
Ocean Medical Products, Ltd.
Cardiovascular · 24d
Cleared Oct 18, 1984
NAMIC ADB ANGIOGRAPHIC DUMP BAG
K843726 · DQO
North American Instrument Corp.
Cardiovascular · 24d
Cleared Oct 17, 1984
ASTRA 2, ASTRA 3, 4 & 6
K842394 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 120d
Cleared Oct 17, 1984
MEDTRONIC 5984-5984LP-5985
K843837 · DXY
Medtronic Vascular
Cardiovascular · 16d
Cleared Oct 16, 1984
TETRAFLEX INTEGRALLY SUPPORTED PTFE
K831822 · DSY
Shiley, Inc.
Cardiovascular · 497d
Cleared Oct 15, 1984
CARDIO METRICS CARDIOTOMY RESERVOIR
K841958 · JOD
Sterile Design, Inc.
Cardiovascular · 154d
Cleared Oct 13, 1984
PERCUTANEOUS BALLOON
K832753 · DSP
Smec, Inc.
Cardiovascular · 425d
Cleared Oct 12, 1984
N2 TEST
K843840
Erich Jaeger, Inc.
Cardiovascular · 11d
Cleared Oct 04, 1984
SPACELABS ICR ARRHYTHMIA MASTER I HOLTER
K842640 · DSI
Spacelabs, Inc.
Cardiovascular · 86d