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

8065–8088 of 18,110

Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular

Cleared Apr 11, 2003

RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH,...

Medtronic Perfusion Systems

Cardiovascular · 36d

Cleared Apr 09, 2003

MEDAMICUS FLOWGUARD PEELABLE INTRODUCER

Medamicus, Inc.

Cardiovascular · 16d

Cleared Apr 09, 2003

EPTFE VASCULAR PROSTHESIS

Cardiovascular · 9d

Cleared Apr 08, 2003

STEREOTAXIS CATHETER ADVANCER SYSTEM

Stereotaxis, Inc.

Cardiovascular · 309d

Cleared Apr 08, 2003

ENVAN HEART RATE MONITOR

Cardiovascular · 36d

Cleared Apr 03, 2003

ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80,...

Avantec Vascular Corp.

Cardiovascular · 86d

Cleared Apr 03, 2003

IVS INTRODUCER SET, MODEL 1003

Integrated Vascular Systems, Inc.

Cardiovascular · 27d

Cleared Mar 31, 2003

VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING

Gish Biomedical, Inc.

Cardiovascular · 174d

Cleared Mar 31, 2003

GISH ARTERIAL FILTER WITH GBS COATING

Gish Biomedical, Inc.

Cardiovascular · 133d

Cleared Mar 31, 2003

IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP,...

Cardiovascular · 74d

Cleared Mar 28, 2003

VERMED A10021 RESTING EKG TAB ELECTRODE

Vermont Medical, Inc.

Cardiovascular · 79d

Cleared Mar 28, 2003

ECHELON MICRO CATHETER, MODEL 105-5092-150

Micro Therapeutics, Inc.

Cardiovascular · 23d

Cleared Mar 28, 2003

Aerotel Medical Systems (1998) , Ltd.

Cardiovascular · 14d

Cleared Mar 28, 2003

ER800 SERIES ECG EVENT RECORDER

Cardiovascular · 10d

Cleared Mar 26, 2003

MODIFICATION TO EXPORT ASPIRATION CATHETER

Medtronic Vascular

Cardiovascular · 64d

Cleared Mar 25, 2003

LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100

Levitronix, LLC

Cardiovascular · 421d

Cleared Mar 25, 2003

SETPOINT ENDOVASCULAR TEMPERATURE PROBE

Radiant Medical

Cardiovascular · 89d

Cleared Mar 21, 2003

BPTRU VITAL SIGNS MONITOR, MODEL BPM-300, & BPTRU PORTABLE AUTOMATED...

Vsm Medtech , Ltd.

Cardiovascular · 186d

Cleared Mar 21, 2003

VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS

Vanguard Medical Concepts, Inc.

Cardiovascular · 67d

Cleared Mar 21, 2003

MODIFICATION TO SOLAR 9500 INFORMATION MONITOR

Ge Medical Systems Information...

Cardiovascular · 25d

Cleared Mar 21, 2003

INFINITY EXPLORER

Siemens Medical Solutions USA, Inc.

Cardiovascular · 23d

Cleared Mar 21, 2003

SIEMENS INFINITY GATEWAY SUITE, MODEL VF2

Siemens Medical Solutions

Cardiovascular · 18d

Cleared Mar 21, 2003

M2376A DEVICELINK SYSTEM

Philips Medical Systems, Inc.

Cardiovascular · 11d

Cleared Mar 20, 2003

ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1...

Terumo Cardiovascular Systems Corp.

Cardiovascular · 196d