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

9769–9792 of 18,110

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

Cleared Jun 03, 1998

SHELHIGH NO-REACT PERICARDIAL PATCHES

Cardiovascular · 177d

Cleared Jun 03, 1998

BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS

C.R. Bard, Inc.

Cardiovascular · 90d

Cleared Jun 02, 1998

CS/3(TM) MONITORS*

Datex-Engstrom, Inc.

Cardiovascular · 162d

Cleared Jun 01, 1998

COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR

Cobe Cardiovascular, Inc.

Cardiovascular · 160d

Cleared May 29, 1998

DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH...

Datascope Corp.

Cardiovascular · 88d

Cleared May 28, 1998

SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496

Spacelabs Medical, Inc.

Cardiovascular · 329d

Cleared May 28, 1998

PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001,...

Cardiovascular · 195d

Cleared May 28, 1998

CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01,...

Cordis Webster, Inc.

Cardiovascular · 73d

Cleared May 26, 1998

MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD

Medtronic Vascular

Cardiovascular · 260d

Cleared May 21, 1998

FAST-CATH (TM) INTRA-CARDIAC INTRODUCER

Cardiovascular · 225d

Cleared May 20, 1998

OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER

Cardiovascular · 30d

Cleared May 19, 1998

SIEMENS MULTIVIEW WORKSTATION ENHANCED WITH DIAGNOSTIC STATEMENTS (REST ECG)

Siemens Medical Solutions USA, Inc.

Cardiovascular · 90d

Cleared May 18, 1998

CRITIKON SOFT BLOOD PRESSURE CUFF

Johnson & Johnson Medical, Inc.

Cardiovascular · 201d

Cleared May 15, 1998

SITESEER ANGIOGRAPHIC CATHETER

C.R. Bard, Inc.

Cardiovascular · 87d

Cleared May 15, 1998

3M CDI QUICK-CELLS WITH HEPARIN TREATMENT

Cardiovascular · 79d

Cleared May 14, 1998

BARD ISOFLOW BLOOD PUMP

C.R. Bard, Inc.

Cardiovascular · 393d

Cleared May 14, 1998

CAPIOX SX HARDSHELL RESERVOIR

Terumo Medical Corp.

Cardiovascular · 63d

Cleared May 13, 1998

SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS

Boston Scientific Scimed, Inc.

Cardiovascular · 23d

Cleared May 12, 1998

ARCHIMED 4210 AND 4220

Biosound Esaote, Inc.

Cardiovascular · 209d

Cleared May 12, 1998

MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE

Graphic Controls Corp.

Cardiovascular · 68d

Cleared May 11, 1998

CORDIS VANGUARD STEERABLE GUIDEWIRES

Cardiovascular · 157d

Cleared May 11, 1998

Universal Medical, Inc.

Cardiovascular · 82d

Cleared May 07, 1998

MUSE CARDIOVASCULAR INFORMATION SYSTEM

Marquette Medical Systems, Inc.

Cardiovascular · 87d

Cleared May 07, 1998

VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT

Cardiovascular · 44d