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
9481–9504 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 23, 1999
CAPIOX CARDIOPLEGIA
K982467 · DTR
Terumo Medical Corp.
Cardiovascular · 343d
Cleared Jun 22, 1999
NAVIPORT DEFLECTABLE TIP GUIDING CATHETER
K974683 · DQY
Cardima, Inc.
Cardiovascular · 553d
Cleared Jun 16, 1999
ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE
K991898 · DQX
Microvena Corp.
Cardiovascular · 12d
Cleared Jun 15, 1999
CORDIS MAXI DS PTA BALLOON CATHETER
K991811 · LIT
Cordis Corp.
Cardiovascular · 19d
Cleared Jun 14, 1999
BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005
K990956 · DQK
Biosensor Corp.
Cardiovascular · 84d
Cleared Jun 14, 1999
TELEMEDICINE 2000
K991307 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 59d
Cleared Jun 11, 1999
CARDIOLIGHT
K982448 · DSH
Capintec, Inc.
Cardiovascular · 331d
Cleared Jun 11, 1999
PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA
K983791 · DWF
Edwards Lifesciences Research Medical
Cardiovascular · 227d
Cleared Jun 11, 1999
BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1
K991831 · DPS
Boston Medical Technologies, Inc.
Cardiovascular · 14d
Cleared Jun 09, 1999
CADISCOPE ELECTRONIC STETHOSCOPE
K990809 · DQD
Caditec AG
Cardiovascular · 90d
Cleared Jun 09, 1999
COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331
K991102 · DTL
Guidant Corp.
Cardiovascular · 69d
Cleared Jun 09, 1999
FOUNTAIN Infusion Catheter and Occluding Guide Wire
K991619 · QEY
Merit Medical Systems, Inc.
Cardiovascular · 29d
Cleared Jun 08, 1999
MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER
K990795 · MTD
Cardiac Pathways Corp.
Cardiovascular · 90d
Cleared Jun 07, 1999
HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA...
K991773 · DSI
Hewlett-Packard GmbH
Cardiovascular · 13d
Cleared Jun 03, 1999
SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM
K983996 · MHX
Spacelabs Medical, Inc.
Cardiovascular · 205d
Cleared Jun 03, 1999
RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777
K990483 · DTB
Biotronik, Inc.
Cardiovascular · 107d
Cleared Jun 03, 1999
ORTHOGONAL EP CATHETERS
K990958 · DRF
Irvine Biomedical, Inc.
Cardiovascular · 73d
Cleared Jun 01, 1999
WRIST TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-303S
K991688 · DXN
Jawon Medical Co., Ltd.
Cardiovascular · 15d
Cleared Jun 01, 1999
UNI-GRAFT K DV VASCULAR GRAFT
K991813 · DSY
Atrium Medical Corp.
Cardiovascular · 5d
Cleared May 26, 1999
CORDIS TEMPO ANGIOGRAPHY CATHETER
K991673 · DQO
Cordis Corp.
Cardiovascular · 9d
Cleared May 25, 1999
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K990239 · DTN
Cobe Cardiovascular, Inc.
Cardiovascular · 120d
Cleared May 20, 1999
WRIST BLOOD PRESSURE METER MODEL SE-330
K973078 · DPW
Sein Electronics Co., Ltd.
Cardiovascular · 640d
Cleared May 20, 1999
WALKCARE P200 SYSTEM
K973592 · JOW
A.Stein - Regulatory Affairs Consulting
Cardiovascular · 605d
Cleared May 18, 1999
FLEXIBLE VASCULAR CLAMP, VERSION 2
K991589 · DXC
Allegiance Healthcare Corp.
Cardiovascular · 11d