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

7153–7176 of 18,110

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

Cleared Oct 27, 2005

MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX

Boston Scientific Corp

Cardiovascular · 24d

Cleared Oct 25, 2005

Hancock/Jaffe Laboratories

Cardiovascular · 53d

Cleared Oct 21, 2005

POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A)

Cardiac Science, Inc.

Cardiovascular · 73d

Cleared Oct 20, 2005

M3046B COMPACT PORTABLE PATIENT MONITORS

Philips Medical Systems

Cardiovascular · 21d

Cleared Oct 20, 2005

D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER

Cardiovascular · 21d

Cleared Oct 19, 2005

BLOOD PRESSURE METER, MODEL CH-432

Citizen Watch Co., Ltd.

Cardiovascular · 82d

Cleared Oct 19, 2005

CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002

Cardionet, Inc.

Cardiovascular · 63d

Cleared Oct 19, 2005

CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159,...

Spectranetics Corp.

Cardiovascular · 35d

Cleared Oct 17, 2005

DUAL SHOT - CONTRAST DELIVERY SYSTEM

Nemoto Kyorindo Co., Ltd.

Cardiovascular · 21d

Cleared Oct 13, 2005

KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD...

Tyco Healthcare/Kendall

Cardiovascular · 100d

Cleared Oct 07, 2005

VITALCAREGIVING SYSTEM

Advanced Monitoring Caregiving, Inc.

Cardiovascular · 119d

Cleared Oct 05, 2005

CARDIOLINE AR 600, AR 1200, AR 2100

Et Medical Devices Spa

Cardiovascular · 117d

Cleared Oct 05, 2005

PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A,...

Philips Medical Systems

Cardiovascular · 107d

Cleared Sep 30, 2005

TECHNO-SCOPE VISUAL STETHOSCOPE

Cardiovascular · 259d

Cleared Sep 29, 2005

CARTO RMT EP NAVIGATION SYSTEM

Biosense Webster, Inc.

Cardiovascular · 365d

Cleared Sep 29, 2005

REFSTAR RMT EXTERNAL REFERENCE PATCH

Biosense Webster, Inc.

Cardiovascular · 332d

Cleared Sep 29, 2005

ADVANTA T-GRAFT

Atrium Medical Corp.

Cardiovascular · 129d

Cleared Sep 29, 2005

NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER

Biosense Webster, Inc.

Cardiovascular · 58d

Cleared Sep 28, 2005

VASCULAR SOLUTIONS PRONTO V3 EXTRACTION CATHETER

Vascular Solutions, Inc.

Cardiovascular · 42d

Cleared Sep 26, 2005

MATRIX HOLTER SYSTEM, MODEL M12

Global Instrumentation, LLC

Cardiovascular · 91d

Cleared Sep 26, 2005

ASAHI TORNUS SUPPORT CATHETER

Asahi Intecc Co., Ltd.

Cardiovascular · 88d

Cleared Sep 22, 2005

MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C

Medtronic Perfusion Systems

Cardiovascular · 23d

Cleared Sep 20, 2005

VENAFLO II VASCULAR GRAFT

Bard Peripheral Vascular, Inc.

Cardiovascular · 29d

Cleared Sep 15, 2005

CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR

Terumo Cardiovascular Systems Corp.

Cardiovascular · 52d