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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×

18,151 results

10993–11016 of 18,151

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

Cleared Mar 17, 1995

LOW PRESSURE INJECTION TUBING, COILED LINE, EXTENSION TUBING

Cardiovascular · 302d

Cleared Mar 17, 1995

SCIMED(R) ENTRE PTCA GUIDE WIRE

Scimed Life Systems, Inc.

Cardiovascular · 87d

Cleared Mar 16, 1995

CARDIOVIT AT-1, P-80

Schiller America, Inc.

Cardiovascular · 85d

Cleared Mar 15, 1995

INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04

Intermedics, Inc.

Cardiovascular · 624d

Cleared Mar 14, 1995

MEDIFRIEND PROFESSIONAL SPHYGMOMANOMETER

Shanghai Medifriend Medical Products...

Cardiovascular · 21d

Cleared Mar 13, 1995

ZOLL PD 1600 SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR

Zoll Medical Corp

Cardiovascular · 301d

Cleared Mar 13, 1995

FLUORO-TIP(R) HEMOSTASIS VALVE INTRODUCER SET

B.Braun Medical, Inc.

Cardiovascular · 130d

Cleared Mar 13, 1995

SCIMED(R) TRIDUIGE(R) GUIDE CATHETERS

Scimed Life Systems, Inc.

Cardiovascular · 82d

Cleared Mar 10, 1995

PRO-SPORT HEART RATE MONITOR

Sensor Dynamics, Inc.

Cardiovascular · 247d

Cleared Mar 10, 1995

PULSE HEART RATE MONITOR

Sensor Dynamics, Inc.

Cardiovascular · 247d

Cleared Mar 08, 1995

NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE...

Cardiovascular · 92d

Cleared Mar 07, 1995

IMD PSD 410 PACEMAKER TRANSMITTER

Integrated Medical Devices, Inc.

Cardiovascular · 203d

Cleared Mar 03, 1995

Cardiovascular · 182d

Cleared Mar 03, 1995

SHERPA SHERPA II AND ASCENT CORONARY GUIDING CATHETERS

Medtronics Interventional Vascular

Cardiovascular · 171d

Cleared Mar 03, 1995

SCIMED CHIOCE PLUS PTCA GUIDE WIRE

Scimed Life Systems, Inc.

Cardiovascular · 135d

Cleared Mar 03, 1995

RMI CIRKUIT-GUARD(TM) PRESSURE RELIEF VALVE

Research Industries Corp.

Cardiovascular · 88d

Cleared Mar 03, 1995

POWERFLEX(TM) 5F PTA BALLOON CATHETER

Cardiovascular · 81d

Cleared Mar 03, 1995

SCIMED 6 FRENCH MICRO-MAX(TM) GUIDE CATHETER

Scimed Life Systems, Inc.

Cardiovascular · 52d

Cleared Mar 01, 1995

DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340

Critikon Company, LLC

Cardiovascular · 266d

Cleared Mar 01, 1995

EK-VIEW(TM) ECG MANAGEMENT SYSTEM

Apcot Medical Systems

Cardiovascular · 76d

Cleared Mar 01, 1995

CANDELA SHEATH SETS

Candela Laser Corp.

Cardiovascular · 16d

Cleared Mar 01, 1995

CANDEKA DUKATIR SETS

Candela Laser Corp.

Cardiovascular · 16d

Cleared Feb 24, 1995

Cardiotronics, Inc.

Cardiovascular · 618d

Cleared Feb 24, 1995

SILICORE SEMI-FLOATER

Electro-Catheter Corp.

Cardiovascular · 507d