Medical Device Manufacturer · US , Kennesaw , GA

Cryolife, Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2006

12

Total

12

Cleared

0

Denied

FDA 510(k) cleared devices by Cryolife, Inc. Cardiovascular ✕

8 devices

1-8 of 8

Cleared Feb 14, 2019

PhotoFix Decellularized Bovine Pericardium

Cardiovascular · 50d

Cleared Dec 04, 2017

PhotoFix Decellularized Bovine Pericardium

Cardiovascular · 146d

Cleared Mar 09, 2017

PhotoFix Decellularized Bovine Pericardium

Cardiovascular · 182d

Cleared Jul 23, 2010

CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH

Cardiovascular · 21d

Cleared May 25, 2010

CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)

Cardiovascular · 323d

Cleared Aug 07, 2009

CRYOPATCH SG PULMONARY HEMI-ARTERY

Cardiovascular · 65d

Cleared Feb 06, 2009

CRYOVALVE SG PULMONARY VALVE AND CONDUIT

Cardiovascular · 109d

Cleared Feb 07, 2008

HUMAN HEART VALVE, CRYOVALVE SG

Cardiovascular · 1556d