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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×

18,027 results

10825–10848 of 18,027

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

Cleared Apr 28, 1995

SCIMED SCEPTOR PTCA GUIDE WIRE

Scimed Life Systems, Inc.

Cardiovascular · 80d

Cleared Apr 28, 1995

SCIMED SCEPTOR EXCHANGE GUIDE WIRE

Scimed Life Systems, Inc.

Cardiovascular · 80d

Cleared Apr 26, 1995

OMNI-TRAC MODIFICATION

Invivo Research, Inc.

Cardiovascular · 553d

Cleared Apr 26, 1995

NOPROFILE OLBERT CATHETER SYSTEM

Meadox Medicals, Div. Boston...

Cardiovascular · 196d

Cleared Apr 26, 1995

CORDIS INTRODUCING CATHETER

Cardiovascular · 167d

Cleared Apr 25, 1995

HEART RATE VARIABILITY SOFTWARE OPTION

Spacelabs, Inc.

Cardiovascular · 63d

Cleared Apr 20, 1995

MARQUETTE DEFIB ELECTRODE

Marquette Electronics, Inc.

Cardiovascular · 400d

Cleared Apr 19, 1995

HOLTER FOR WINDOWS

North East Monitoring, Inc.

Cardiovascular · 805d

Cleared Apr 19, 1995

CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATION

Electro-Catheter Corp.

Cardiovascular · 646d

Cleared Apr 19, 1995

OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION

Electro-Catheter Corp.

Cardiovascular · 646d

Cleared Apr 19, 1995

TIP DEFLECTOR (GENESIS)

Electro-Catheter Corp.

Cardiovascular · 287d

Cleared Apr 19, 1995

KAPLAN-SIMPSON INFUSASLEEVE CATHETER

Cardiovascular · 68d

Cleared Apr 17, 1995

SCIMED(R) COURIER GUIDE CATHETER

Scimed Peripheral Interventions

Cardiovascular · 115d

Cleared Apr 14, 1995

GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300

General Devices

Cardiovascular · 465d

Cleared Apr 14, 1995

SCIMED(R) CHOICE(TM) PT EXCHANGE PTCA GUIDE WIRE

Scimed Life Systems, Inc.

Cardiovascular · 81d

Cleared Apr 14, 1995

CORDIS STEERABLE GUIDEWIRES

Cardiovascular · 78d

Cleared Apr 12, 1995

Mennen Medical, Inc.

Cardiovascular · 460d

Cleared Apr 12, 1995

ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE...

Arbo Medical, Inc.

Cardiovascular · 443d

Cleared Apr 12, 1995

BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER

Cardiovascular · 175d

Cleared Apr 12, 1995

Target Therapeutics

Cardiovascular · 93d

Cleared Apr 10, 1995

SIEMENS SIRECUST 700 BEDSIDE MONITOR MODIFICATIONS

Siemens Medical Solutions USA, Inc.

Cardiovascular · 649d

Cleared Apr 10, 1995

SC 6000/ SC 6000P/ R50

Siemens Medical Solutions USA, Inc.

Cardiovascular · 216d

Cleared Apr 07, 1995

SIEMENS CLINICAL WORK STATION

Siemens Medical Electronics

Cardiovascular · 533d

Cleared Apr 06, 1995

TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER

Rlt Medical Assoc., Inc.

Cardiovascular · 535d