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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×

18,053 results

12337–12360 of 18,053

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

Cleared Jan 31, 1991

PATIENT CARE MANAGEMENT SYSTEM MODIFICATION

Spacelabs, Inc.

Cardiovascular · 28d

Cleared Jan 30, 1991

FUKUDA DENSHI MODEL LX-3100

Fukuda Denshi USA, Inc.

Cardiovascular · 180d

Cleared Jan 30, 1991

MODEL #250 DEFIB CABLE

Cardiotronics, Inc.

Cardiovascular · 121d

Cleared Jan 30, 1991

DATASCOPE INTERLOCK GUIDE WIRE EXTENSION

Datascope Corp.

Cardiovascular · 57d

Cleared Jan 30, 1991

Cardiac Pacemakers, Inc.

Cardiovascular · 43d

Cleared Jan 30, 1991

PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER

Mallinckrodt Medical

Cardiovascular · 34d

Cleared Jan 28, 1991

DIAGNOSTIC ULTRASOUND VERSADOPP 1000

Diagnostic Ultrasound Corp.

Cardiovascular · 97d

Cleared Jan 23, 1991

FLEXIBLE INTRACARDIAC SUCTION DEVICE

Gish Biomedical, Inc.

Cardiovascular · 78d

Cleared Jan 23, 1991

TOPICAL COOLING PAD, MODEL 7000

Daily Medical Products, Inc.

Cardiovascular · 42d

Cleared Jan 18, 1991

BIFLEX(TM) ANNULOPLASTY RING

St. Jude Medical, Inc.

Cardiovascular · 248d

Cleared Jan 18, 1991

SERIES 1500 RESPONDER

Marquette Electronics, Inc.

Cardiovascular · 206d

Cleared Jan 18, 1991

OMRON OSCILLOMETRIC DIGITAL BP MONITOR-HEM-405C

Omron Marshall Products, Inc.

Cardiovascular · 185d

Cleared Jan 18, 1991

ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER

Arzco Medical Electronics, Inc.

Cardiovascular · 185d

Cleared Jan 18, 1991

OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE

Telectronics Pacing Systems, Inc.

Cardiovascular · 183d

Cleared Jan 18, 1991

COMPACT MONITOR SMK 210,211,230,231,240

Ppg Hellige B.V.

Cardiovascular · 147d

Cleared Jan 18, 1991

FOCUS T41,T41F,T43, T43F,T44F

Cardiovascular · 123d

Cleared Jan 16, 1991

DATASCOPE ARTERIAL CANNULA W/ACCESS PORT

Datascope Corp.

Cardiovascular · 212d

Cleared Jan 16, 1991

Life Sciences Manufacturing, Inc.

Cardiovascular · 154d

Cleared Jan 16, 1991

BIFURCATED GORE TEX STRETCH VASCULAR GRAFT

W.L. Gore & Associates, Inc.

Cardiovascular · 120d

Cleared Jan 16, 1991

STEALTH DILATION CATHETER SYSTEM/MODIFICATION

Target Therapeutics

Cardiovascular · 124d

Cleared Jan 16, 1991

CONDOR DIGITAL INFLATION SYRINGE

Professional Medical Services

Cardiovascular · 72d

Cleared Jan 16, 1991

LAB-SITE SAFETY NEEDLE

Telos Medical Corp.

Cardiovascular · 70d

Cleared Jan 15, 1991

9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)

Kontron Instruments, Inc.

Cardiovascular · 174d

Cleared Jan 15, 1991

SERIES 51 AND 53 DISPOSABLE PRESSURE TRANSDUCERS

Baxter Healthcare Corp

Cardiovascular · 85d