FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,110 results
5905–5928 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 15, 2009
MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT
K082403 · DTZ
Gish Biomedical, Inc.
Cardiovascular · 267d
Cleared May 14, 2009
BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER
K081130 · DQY
Bridgepoint Medical
Cardiovascular · 388d
Cleared May 13, 2009
ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM
K081803 · DRF
St Jude Medical
Cardiovascular · 321d
Cleared May 12, 2009
AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS...
K083214 · DQY
Aga Medical Corp.
Cardiovascular · 193d
Cleared May 08, 2009
ACCUTORR V MONITOR, MODEL 0998-00-2000
K091068 · DXN
Datascope Corp., Patient Monitoring...
Cardiovascular · 24d
Cleared May 08, 2009
ZIO PATCH, MODEL Z100
K090363 · DSH
iRhythm Technologies, Inc.
Cardiovascular · 84d
Cleared May 07, 2009
ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC
K090428 · KRH
Genesee Biomedical, Inc.
Cardiovascular · 77d
Cleared May 07, 2009
HANSEN MEDICAL ARTISAN S CONTROL CATHETER
K090365 · DXX
Hansen Medical, Inc.
Cardiovascular · 83d
Cleared May 07, 2009
CIRCULATOR BOOT
K082134 · DRN
Circulator Boot Corp.
Cardiovascular · 282d
Cleared May 07, 2009
SAFEFLO VENA CAVA FILTER
K081138 · DTK
Rmt Medical Technilogies, Inc.
Cardiovascular · 381d
Cleared May 06, 2009
HD GUIDE CATHETER
K090335 · DQY
Concentric Medical, Inc.
Cardiovascular · 85d
Cleared May 06, 2009
MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00
K083922 · DQO
Micrus Endovascular Corporation
Cardiovascular · 126d
Cleared May 04, 2009
CROSS-PILOT TURBO ELITE SUPPORT CATHETER
K090913 · DQY
Spectranetics Corp.
Cardiovascular · 33d
Cleared May 01, 2009
ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND...
K090870 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 32d
Cleared May 01, 2009
MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS...
K090849 · DQY
Ev3, Inc.
Cardiovascular · 32d
Cleared May 01, 2009
RESTEP DVY SYSTEM, MODEL RSP-101
K090308 · JOW
Stortford Medical, LLC
Cardiovascular · 84d
Cleared Apr 30, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556
K090963 · DXN
Andon Health Co, Ltd.
Cardiovascular · 24d
Cleared Apr 30, 2009
SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE
K090556 · MHX
Spacelabs Healthcare Medical...
Cardiovascular · 59d
Cleared Apr 27, 2009
ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER
K090822 · DQY
Cook, Inc.
Cardiovascular · 32d
Cleared Apr 27, 2009
STEERABLE GUIDE CATHETER
K083793 · DRA
Evalve, Inc.
Cardiovascular · 126d
Cleared Apr 23, 2009
CLUE MEDICAL AND CLUE MEDICAL BASIC
K083630 · DXH
Telovital GmbH Telemedizin
Cardiovascular · 136d
Cleared Apr 22, 2009
ULTIMUM/ENGAGE/ENGAGE TR
K091137 · DYB
St Jude Medical
Cardiovascular · 2d
Cleared Apr 22, 2009
BLOOD MONITORING UNIT, MODEL BMU 40
K090147 · DRY
Maquet Cardiopulmonary, AG
Cardiovascular · 91d
Cleared Apr 22, 2009
HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS
K090074 · JOW
Hygia Health Services, Inc.
Cardiovascular · 100d