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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,027 results
11449–11472 of 18,027
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 19, 1993
EXTERNAL DEMAND PACEMAKER
K923621 · DTE
Oscor Medical Corp.
Cardiovascular · 302d
Cleared May 18, 1993
STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE
K925661 · KRL
Sorin Biomedica, Fiat, USA, Inc.
Cardiovascular · 189d
Cleared May 18, 1993
LIFEPAK 10 DEFIBRILLATOR/MONITOR W/OPT PACEMAKER
K931053 · LDD
Physio-Control Corp.
Cardiovascular · 71d
Cleared May 17, 1993
ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS
K922840 · DTL
Gish Biomedical, Inc.
Cardiovascular · 339d
Cleared May 14, 1993
CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER
K923868 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 284d
Cleared May 14, 1993
MEDTRONIC MINIX & MINIX ST PULSE GENERATORS
K930770 · DXY
Medtronic Vascular
Cardiovascular · 87d
Cleared May 13, 1993
CARDIOTOMY RESERVOIR W/20 MICRON FILITER
K920178 · DTN
Lifestream Int'L, Inc.
Cardiovascular · 485d
Cleared May 13, 1993
SYSTEM 7500 NIBP/SA02
K924910 · DXN
Advanced Medical Instruments, Inc.
Cardiovascular · 226d
Cleared May 13, 1993
OMRON OSCILLOMETRIC DIGITAL BLOOD PRESSURE MONIT.
K930798 · DXN
Omron Healthcare, Inc.
Cardiovascular · 86d
Cleared May 11, 1993
MODIFICATION OF SARNS TWO STAGE VENOUS CANNULA
K920902 · DWF
3M Health Care, Sarns
Cardiovascular · 440d
Cleared May 11, 1993
COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR
K923272 · DTZ
Cobe Laboratories, Inc.
Cardiovascular · 309d
Cleared May 11, 1993
BARD WILLIAM HARVEY TWO STAGE CANNULA
K930684 · DWF
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared May 07, 1993
MARQUETTE SL SERIES TRANSPORT REMOTE ACQUISITION
K921669 · LOS
Marquette Electronics, Inc.
Cardiovascular · 394d
Cleared May 07, 1993
SIEMENS SIRECUST 700 BEDSIDES/ACCESSORIES, MODIFI
K921930 · DPS
Siemens Medical Electronics
Cardiovascular · 378d
Cleared May 07, 1993
MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540E
K924206 · DWA
Medtronic Bio-Medicus, Inc.
Cardiovascular · 260d
Cleared May 07, 1993
CALF GARMENT DVT10(S) COMPRESSIBLE LIMB SLEEVE
K925717 · JOW
Huntleigh Healthcare, Inc.
Cardiovascular · 176d
Cleared May 07, 1993
BARD(R) WILLIAM HARVEY(R) ARTERIAL STRAIGH CANNULA
K930620 · DWF
C.R. Bard, Inc.
Cardiovascular · 88d
Cleared May 06, 1993
MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550
K924205 · DWA
Medtronic Bio-Medicus, Inc.
Cardiovascular · 259d
Cleared May 06, 1993
CORDIS 9 F GUIDING CATHETER
K925131 · DQY
Cordis Corp.
Cardiovascular · 205d
Cleared May 06, 1993
MEDTRONIC INTERVENTIONAL VASCULAR SHERPA GUIDEWIRE
K925342 · DQX
Medtronics Interventional Vascular
Cardiovascular · 198d
Cleared May 06, 1993
BARD WILLIAM HARVEY AORTIC ROOT CARDIOPLEGIA CANNU
K930593 · DWF
C.R. Bard, Inc.
Cardiovascular · 91d
Cleared Apr 30, 1993
ITC CATHETERS W/ HYDROMER
K922609 · DQY
Interventional Therapeutics Corp.
Cardiovascular · 332d
Cleared Apr 30, 1993
EP AMP, MODEL #901
K925346 · DRR
Quinton Electrophysiology Corp.
Cardiovascular · 190d
Cleared Apr 30, 1993
BALANCED(TM) NYLON BLADDER
K930604 · DXQ
Pymah Corp.
Cardiovascular · 84d