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U.S. Department of Health and Human Services

For Consumers

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FDA-Approved Medical Devices for Cardiology and Vascular Diseases

The medical devices listed in this section include some of the newest medical technology available. The links in each list contain information about what medical uses the device is cleared or approved for, when it can be used, and when it should not be used. This information, along with information from your doctor and other sources, can help make you an informed participant in your health care.

For additional information about approved and cleared medical devices, see Device Approvals and Clearances

 

2012

Product
Manufacturer
Category
Approval Date
Abbott Vascular
Stent
7/31/2012
Boston Scientific Corporation
Stent
6/1/2012
Boston Scientific Corporation
Stent
4/13/2012
Medinol Ltd
Stent
4/12/2012
Medtronic, Inc. Cardiac Rhythm Disease Management (CRDM)
Defibrillator
4/4/2012
Cook Incorporated
Endovascular Graft
4/4/2012
ev3, Inc.
Stent
3/7/2012
Boston Scientific Corporation
Stent
2/22/2012
Boston Scientific Corporation
Stent
2/22/2012
Abbott Vascular
Stent
2/22/2012
Boston Scientific Corporation
Stent
2/22/2012
Medtronic Vascular, Inc
Stent
2/17/2012
W.L. Gore & Associates, Inc.
Endovascular Stent
1/13/2012
 

2011

Product
Manufacturer
Category
Approval Date
Berlin Heart, GmbH
Ventricular Assist Device
12/16/2011
Edwards Lifesciences
Heart valve
11/2/2011
Abbott Vascular
Stent
11/1/2011
Medtronic Vascular
Stent
10/26/2011
Abbott Vascular
Stent
5/24/2011
Abbott Vascular
Stents
5/6/2011
Boston Scientific Corporation
Stents
4/22/2011
St. Jude Medical
Heart valve
4/20/2011
Medtronic, Inc
Pacing
2/8/2011
Cook, Inc.
Stents
1/14/2011

 

2010

Product
Manufacturer
Category
Approval Date
Bard Peripheral Vascular, Inc.
Stent
12/23/2010
Medtronic Vascular
Stent
12/16/2010
Boston Scientific
Defibillator
9/16/2010
Medtronic Vascular
Stent
3/17/2010
Boston Scientific Corporation
Stent
3/5/2010
Medtronic Heart Valves, Inc.
Heart valve
1/25/2010

 

2009

Product
Manufacturer
Category
Approval Date
Boston Scientific Corporation
Stent
7/13/2009
Boston Scientific Corporation
Stent
5/21/2009
Medtronic, Inc.
Pacemaker leads
4/7/2009
Bard Peripheral Vascular, Inc.
Stent
2/13/2009

 

2008

Product
Manufacturer
Category
Approval Date
Boston Scientific Corporation
Stent
12/11/2008
Bard Peripheral Vascular, Inc.
Stent
12/4/2008
Boston Scientific Corporation
Stent
10/23/2008
Abbott Vascular
Stent
7/2/2008
Medtronic, Inc.
Pacemaker
6/13/2008
Medtronic Vascular
Stent
6/5/2008
William Cook Europe, ApS
Endovascular graft
5/21/2008
ELA Medical, Inc.
Ventricular Assist Device
5/15/2008
Biotronik Inc.
Pacemaker
5/12/2008
Thoratec Corporation
Ventricular Assist Device
4/21/2008
Medtronic Vascular
Endovascular Graft
4/15/2008
Guidant Corporation
Implantable Cardioverter Defibrillator
3/13/2008
Medtronic Vascular
Stents
2/1/2008