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

7393–7416 of 18,110

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

Cleared Feb 08, 2005

STEREOTAXIS ENDOVASCULAR GUIDE WIRE

Stereotaxis, Inc.

Cardiovascular · 116d

Cleared Feb 08, 2005

SELECT 3D ARTERIAL CANNULA

Medtronic Perfusion Systems

Cardiovascular · 83d

Cleared Feb 08, 2005

QUANTIX/OR BLOOD FLOW MONITOR

Cardiovascular · 26d

Cleared Feb 04, 2005

ZOLL AED PRO EXTERNAL DEFIBRILLATOR

ZOLL Medical Corporation

Cardiovascular · 206d

Cleared Feb 03, 2005

REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM

Ep Technologies, Inc.

Cardiovascular · 71d

Cleared Feb 03, 2005

BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER

Biomerix Corporation

Cardiovascular · 57d

Cleared Feb 03, 2005

TRANSMITTER, ZS-940PA SERIES

Nihon Kohden America, Inc.

Cardiovascular · 45d

Cleared Feb 03, 2005

MODIFIED ACUMEN SHEATH, MODEL TTWO767

Acumen Medical, Inc.

Cardiovascular · 30d

Cleared Feb 03, 2005

TRELLIS-8 PERIPHERAL INFUSION SYSTEM

Bacchus Vascular, Inc.

Cardiovascular · 10d

Cleared Feb 01, 2005

D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY...

Cardiovascular · 61d

Cleared Feb 01, 2005

VITELCARE TURTLE, MODEL 400

Visual Telecommunications Network, Inc.

Cardiovascular · 55d

Cleared Feb 01, 2005

MODEL SC-3008 SEQUENTIAL CIRCULATOR

Bio Compression Systems, Inc.

Cardiovascular · 50d

Cleared Jan 31, 2005

ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS

Cardiovascular Systems Incorporated

Cardiovascular · 229d

Cleared Jan 31, 2005

MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER

Vascular Solutions, Inc.

Cardiovascular · 98d

Cleared Jan 31, 2005

DYNAFLO BYPASS GRAFT

Bard Peripheral Vascular, Inc.

Cardiovascular · 21d

Cleared Jan 27, 2005

AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304

St. Jude Medical, Daig Division, Inc.

Cardiovascular · 122d

Cleared Jan 27, 2005

PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW3003 AND EW3037

Matsushita Electric Works, Ltd.

Cardiovascular · 107d

Cleared Jan 27, 2005

AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100

Amplife Corporation

Cardiovascular · 35d

Cleared Jan 27, 2005

HORIZON ANGIO CATHLAB

Mennen Medical , Ltd.

Cardiovascular · 31d

Cleared Jan 26, 2005

CARDIOSTATION-100 (CS-100)

Cardiovascular · 280d

Cleared Jan 26, 2005

VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND...

Edwards Lifesciences, LLC

Cardiovascular · 82d

Cleared Jan 21, 2005

MODIFICATION TO OUTBACK CATHETER

Cardiovascular · 30d

Cleared Jan 21, 2005

INFINITY GATEWAY SUITE, VF4

Draeger Medical Systems, Inc.

Cardiovascular · 29d

Cleared Jan 19, 2005

Cardiovascular · 168d