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

7753–7776 of 18,110

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

Cleared Feb 04, 2004

PRESS-MATE BX-10 VITAL SIGN MONITOR

Colin Medical Instruments Corp.

Cardiovascular · 145d

Cleared Feb 04, 2004

SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055,...

Bacchus Vascular, Inc.

Cardiovascular · 42d

Cleared Jan 30, 2004

JOSTRA SUCKERS, MODEL JS

Cardiovascular · 674d

Cleared Jan 30, 2004

MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH

Boston Scientific Corp

Cardiovascular · 30d

Cleared Jan 29, 2004

SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011

Medtronic Vascular

Cardiovascular · 30d

Cleared Jan 28, 2004

SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000

Sontra Medical, Inc.

Cardiovascular · 450d

Cleared Jan 28, 2004

RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100

Recom Managed Systems, Inc.

Cardiovascular · 135d

Cleared Jan 22, 2004

MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69

Medtronic Inc. Cardiac Rhythm Management

Cardiovascular · 30d

Cleared Jan 16, 2004

NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT

Cardiovascular · 92d

Cleared Jan 16, 2004

PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER

Precision Vascular

Cardiovascular · 49d

Cleared Jan 15, 2004

EASI ECG ALGORITHM

Philips Medical Systems

Cardiovascular · 70d

Cleared Jan 15, 2004

SOLAR 9500 INFORMATION MONITOR

Ge Medical Systems Information...

Cardiovascular · 24d

Cleared Jan 13, 2004

D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT...

Cardiovascular · 90d

Cleared Jan 13, 2004

FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH

Flowmedica, Inc.

Cardiovascular · 62d

Cleared Jan 12, 2004

BOSTON SCIENTIFIC V-18 CONTROL WIRE

Boston Scientific Corp

Cardiovascular · 45d

Cleared Jan 12, 2004

MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM

Intra Luminal Therapeutics, Inc.

Cardiovascular · 25d

Cleared Jan 09, 2004

BATTERY PACK, RECHARGEABLE, MODELS MLA0051, MLA90479, MNC5169L/P, MNC1000EKG,...

Access Battery, Inc.

Cardiovascular · 191d

Cleared Jan 08, 2004

D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS

Cardiovascular · 16d

Cleared Jan 07, 2004

SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM

Intra Luminal Therapeutics, Inc.

Cardiovascular · 190d

Cleared Jan 07, 2004

LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES

Cardiovascular · 58d

Cleared Dec 19, 2003

VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER

Vascular Solutions, Inc.

Cardiovascular · 105d

Cleared Dec 19, 2003

LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01,...

LeMaitre Vascular, Inc.

Cardiovascular · 80d

Cleared Dec 19, 2003

MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V

Living Data Technologies Corporation

Cardiovascular · 28d

Cleared Dec 19, 2003

HYDROPHILIC GUIDEWIRE

Lake Region Mfg., Inc.

Cardiovascular · 17d