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

8089–8112 of 18,110

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

Cleared Mar 18, 2003

VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ACCESSORY CABLES

Vanguard Medical Concepts, Inc.

Cardiovascular · 75d

Cleared Mar 14, 2003

GISH TUBING AND CONNECTORS WITH GBS COATING

Gish Biomedical, Inc.

Cardiovascular · 65d

Cleared Mar 14, 2003

CPCA2000 COUNTERPULSATION SYSTEM

Cardiovascular · 23d

Cleared Mar 12, 2003

CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1

Biosensors International-USA

Cardiovascular · 266d

Cleared Mar 12, 2003

PHILIPS MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS WITH PORTAL...

Philips Medical Systems, Inc.

Cardiovascular · 65d

Cleared Mar 11, 2003

REPROCESSED COMPRESSION SLEEVES

Alliance Medical Corp.

Cardiovascular · 90d

Cleared Mar 11, 2003

MODIFIED CONCENTRIC RETRIEVER, MODEL 90037

Concentric Medical, Inc.

Cardiovascular · 26d

Cleared Mar 10, 2003

DELWA-STAR WS-FM BLOOD PRESSURE AND BODY FAT MONITOR

Cardiovascular · 90d

Cleared Mar 07, 2003

REPROCESSED COMPRESSION SLEEVES

Alliance Medical Corp.

Cardiovascular · 87d

Cleared Mar 07, 2003

NAUTICA MICRO CATHETER, MODEL 105-5094-153

Micro Therapeutics, Inc.

Cardiovascular · 81d

Cleared Mar 06, 2003

COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700

Cobe Cardiovascular, Inc.

Cardiovascular · 22d

Cleared Mar 05, 2003

SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING

Gish Biomedical, Inc.

Cardiovascular · 86d

Cleared Mar 05, 2003

MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR

Cardiovascular · 22d

Cleared Mar 04, 2003

ANESTHESIA MONITOR

Nihon Kohden America, Inc.

Cardiovascular · 50d

Cleared Mar 04, 2003

SKINTACT ECG TAB ELECTRODE

Leonhard Lang GmbH

Cardiovascular · 13d

Cleared Mar 03, 2003

CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING)...

Cardiovascular · 12d

Cleared Feb 26, 2003

TYTAN ELECTRONIC STETHOSCOPES (MODEL #600)

Tytan Medical Corp.

Cardiovascular · 119d

Cleared Feb 26, 2003

MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100

Cardiovention, Inc.

Cardiovascular · 42d

Cleared Feb 26, 2003

QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030

Cardiovascular · 30d

Cleared Feb 26, 2003

MODIFICATION TO DASH 3000/4000 PATIENT MONITOR

Ge Medical Systems Information...

Cardiovascular · 16d

Cleared Feb 21, 2003

COAXIA FLOCONTROL CATHETER

Cardiovascular · 88d

Cleared Feb 20, 2003

MAGIC INFUSION CATHETER

Advanced Interventional Technologies,...

Cardiovascular · 136d

Cleared Feb 20, 2003

GELBFISH FLEX VASCULAR DILATOR

Vascumetrix, LLC

Cardiovascular · 27d

Cleared Feb 19, 2003

TRAVELAIR PORTABLE COMPRESSION SYSTEM

Dynamic Air, Inc.

Cardiovascular · 216d