Cryolife Inc

FDA Filings

This page includes the latest FDA filings for Cryolife Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USANEW YORK STOCK EXCHANGECRYDUNS 119253177
FDA Registration(s)
Registration Number1063481
FEI Number3001451326
NameCryoLife, Inc.
Owner & OperatorCryoLife, Inc.
Contact Address1655 ROBERTS BLVD., N.W. --
Kennesaw GA 30144 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1655 Roberts Blvd NW
KENNESAW, GA 30144 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
CRYOLIFE, INC.
BioGlue® Surgical Adhesive2021-12-09
CRYOLIFE, INC.
BioGlue Surgical Adhesive2021-07-23
CryoLife, Inc.
PhotoFix2019-12-27
CryoLife, Inc.
PhotoFix2019-12-27
CryoLife, Inc.
PhotoFix2019-12-27
CRYOLIFE, INC.
BioGlue Surgical Adhesive2019-12-20
CRYOLIFE, INC.
BioGlue Surgical Adhesive2019-08-14
CRYOLIFE, INC.
TMR Holmium Laser System2019-05-02
Cryolife, Inc.
PhotoFix Decellularized Bovine Pericardium PFP8X142019-04-08
CryoLife, Inc.
PhotoFix Decellularized Bovine Pericardium2019-02-14
CRYOLIFE, INC.
Bioglue Surgical Adhesive2019-01-04
CRYOLIFE, INC.
BioGlue Surgical Adhesive2018-11-01
Cryolife, Inc.
CryoValve® SG Pulmonary Human Heart Valve SGPV102018-07-24
Cryolife, Inc.
CryoValve® SG Pulmonary Human Heart Valve SGPV002018-07-24
CRYOLIFE, INC.
TMR Holmium Laser System2018-07-10
Cryolife, Inc.
BioGlue Surgical Adhesive BGDTE-102018-07-06
Cryolife, Inc.
BioGlue Surgical Adhesive BG3510-5-US2018-07-06
Cryolife, Inc.
BioGlue Surgical Adhesive BGST-162018-07-06
Cryolife, Inc.
BioGlue Surgical Adhesive BGAT-27-SY2018-07-06
Cryolife, Inc.
BioGlue Surgical Adhesive BGAT-SY2018-07-06
Cryolife, Inc.
CryoPatch® SG Pulmonary Human Cardiac Branch Patch SGP0202018-07-06
Cryolife, Inc.
CryoPatch® SG Pulmonary Human Cardiac Trunk Patch SGP0102018-07-06
Cryolife, Inc.
CryoPatch® SG Pulmonary Human Cardiac Hemi-Artery Patch SGPH002018-07-06
Cryolife, Inc.
Bioglue Surgical Adhesive BGDTE-272018-07-06
Cryolife, Inc.
BioGlue Surgical Adhesive BG3515-5-US2018-07-06
Cryolife, Inc.
BioGlue Surgical Adhesive BG3502-5-US2018-07-06
Cryolife, Inc.
BioGlue Surgical Adhesive BGST-122018-07-06
Cryolife, Inc.
BioGlue Surgical Adhesive BGAT-10-SY2018-07-06
Cryolife, Inc.
CardioGenesis HP-PRL52018-07-06
Cryolife, Inc.
CardioGenesis HP-SG32018-07-06
Cryolife, Inc.
CardioGenesis LSR-SG2100S2018-07-06
CRYOLIFE, INC.
BioGlue Surgical Adhesive2018-06-25
Cryolife, Inc.
PhotoFix Decellularized Bovine Pericardium PFP2X92018-05-31
Cryolife, Inc.
PhotoFix Decellularized Bovine Pericardium PFP1X142018-05-31
Cryolife, Inc.
PhotoFix Decellularized Bovine Pericardium PFP1X102018-05-31
Cryolife, Inc.
PhotoFix Decellularized Bovine Pericardium PFP4X42018-05-31
Cryolife, Inc.
PhotoFix Decellularized Bovine Pericardium PFP0.8X82018-03-29
Cryolife, Inc.
PhotoFix Decellularized Bovine Pericardium PFP1X62018-03-29
Cryolife, Inc.
PhotoFix Decellularized Bovine Pericardium PFP 6x82018-03-29
Cryolife, Inc.
HeRO® Graft Adapter HERO 10042018-03-29
Cryolife, Inc.
HeRO® Graft Accessory Component Kit HERO 10032018-03-29
Cryolife, Inc.
HeRO® Graft Arterial Graft Component HERO 10022018-03-29
Cryolife, Inc.
HeRO® Graft Venous Outflow Component HERO 10012018-03-29
CRYOLIFE, INC.
BioGlue Surgical Adhesive2018-01-03
CryoLife, Inc.
PhotoFix Decellularized Bovine Pericardium2017-12-04
CRYOLIFE, INC.
BioGlue Surgical Adhesive2017-09-12
CRYOLIFE, INC.
TMR Holmium Laser System2017-09-08
CRYOLIFE, INC.
TMR Holmium Laser System2017-08-31
CRYOLIFE, INC.
BioGlue Surgical Adhesive2017-08-21
CRYOLIFE, INC.
CardioGenesis TMR System2017-08-07
CRYOLIFE, INC.
TMR Holmium Laser System2017-07-28
CryoLife, Inc.
PhotoFix Decellularized Bovine Pericardium2017-03-09
CRYOLIFE, INC.
BIOGLUE SURGICAL ADHESIVE2017-02-10
CRYOLIFE, INC.
BIOGLUE SURGICAL ADHESIVE2016-09-08
CRYOLIFE, INC.
CARDIOGENESIS TMR LASER SYSTEM2016-08-23
CryoLife, Inc.
Chordal Sizer2016-08-18
CryoLife, Inc.
On-X Instruments: handle and rotators2016-08-17
CRYOLIFE, INC.
BIOGLUE SURGICAL ADHESIVE2016-07-07
CRYOLIFE, INC.
TMR HOLMIUM LASER SYSTEM2016-06-23
CRYOLIFE, INC.
TMR HOLMIUM LASER SYSTEM2016-06-21
CryoLife, Inc.
On-X Prosthetic Heart Valves2016-05-13
CryoLife, Inc.
On-X Prosthetic Aortic Heart Valves with Anatomic Sewing Ring2016-05-13
CryoLife, Inc.
On-X Conform-X Prosthetic Heart Valves2016-05-13
CryoLife, Inc.
On-X AAP Ascending Aortic Prosthesis2016-05-13
CryoLife, Inc.
PhotoFix Decellularized Bovine Pericardium2016-05-13
CryoLife, Inc.
Chord-X Loops2016-05-13
CryoLife, Inc.
Chord-X ePTFE Suture2016-05-13
CryoLife, Inc.
On-X Heart Valve Instruments2016-05-13
CryoLife, Inc.
On-X Heart Valve Instrumentation2016-05-13
CRYOLIFE, INC.
BIOGLUE SURGICAL ADHESIVE2016-05-04
CRYOLIFE, INC.
BIOGLUE SURGICAL ADHESIVE2016-04-27
CRYOLIFE, INC.
BIOGLUE SURGICAL ADHESIVE2016-04-07
CRYOLIFE, INC.
CARDIOGENESIS TMR SYSTEM2015-12-22
CRYOLIFE, INC.
BIOGLUE SURGICAL ADHESIVE2015-09-24
CRYOLIFE, INC.
PEARL 8.0 HANDPIECE2015-04-03
CryoLife, Inc.
TMR 20002014-11-05
CryoLife, Inc.
SoloGrip III2014-11-05
CryoLife, Inc.
Solargen 2100S2014-11-05
CryoLife, Inc.
CardioGenesis2014-11-05
CRYOLIFE, INC.
CARDIOGENESIS TMR SYSTEM2014-05-07
CryoLife, Inc.
PerClot Topical Hemostatic Powder2014-04-22
CRYOLIFE, INC.
PERCLOT TOPICAL2014-04-03
CRYOLIFE, INC.
PEARL 8.0 HANDPIECE2014-01-28
CryoLife, Inc.
ProPatch Soft Tissue Repair Matrix2013-12-11
CryoLife, Inc.
CryoPatch SG Pulmonary Human Cardiac Patch2013-12-11
CryoLife, Inc.
CryoValve SG Pulmonary Valve2013-12-11
CryoLife, Inc.
CryoValve SG Pulmonary Valve and Conduit2013-12-11
CRYOLIFE, INC.
BIOGLUE SURGICAL ADHESIVE2013-09-06
CRYOLIFE, INC.
CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM2013-05-31
CRYOLIFE, INC.
PEARL 8.0 HANDPIECE FOR TRANSMYOCARDIAL REVASCULARIZATION (TMR) WITH THE CARDIOGENESIS HOLMIUM: YAG LASER SYSTEM2012-12-18
CRYOLIFE, INC.
CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM2012-09-13
CRYOLIFE, INC.
CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM2012-07-26
CRYOLIFE, INC.
TMR2000 HOLMIUM LASER SYSTEM2012-05-25
CRYOLIFE, INC.
BIOGLUE SURGICAL ADHESIVE2012-03-07
CRYOLIFE, INC.
CARDIOGENESIS HOLMIUM TMR SYSTEM2012-02-22
CRYOLIFE, INC.
PROPATCH SOFT TISSUE REPAIR MATRIX2012-01-10
CRYOLIFE, INC.
CARDIOGENESIS TMR SYSTEM2011-12-16
CRYOLIFE, INC.
PROPATCH SOFT TISSUE REPAIR MATRIX2010-09-16
CRYOLIFE, INC.
CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH2010-07-23
CRYOLIFE, INC.
CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)2010-05-25
CRYOLIFE, INC.
BIOGLUE SURGICAL ADHESIVE2010-05-12
CRYOLIFE, INC.
CARDIOGENESIS TMR 2000 HOLMIUM LASER SYSTEM2010-04-15
CRYOLIFE, INC.
CARDIOGENESIS TMR SYSTEM2009-10-20
CRYOLIFE, INC.
CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH2009-08-07
CRYOLIFE, INC.
BIOGLUE SURGICAL ADHESIVE2009-06-26
CRYOLIFE, INC.
BIOGLUE SURGICAL ADHESIVE2009-05-01
CRYOLIFE, INC.
CRYOVALVE SG PULMONARY VALVE AND CONDUIT2009-02-06
CRYOLIFE, INC.
TMR HOLMIUM LASER SYSTEM2008-12-30
CRYOLIFE, INC.
SOLARGEN 2100S LASER2008-09-11
CRYOLIFE, INC.
BIOGLUE2008-06-24
CRYOLIFE, INC.
HUMAN HEART VALVE, CRYOVALVE SG2008-02-07
CRYOLIFE, INC.
TMR2000 HOLMIUM LASER SYSTEM2007-11-05
CryoLife, Inc.
BioGlue (R) Surgical Adhesive2007-11-02
CRYOLIFE, INC.
BIOGLUE SURGICAL ADHESIVE2007-10-18
CRYOLIFE, INC.
BIOGLUE SURGICAL ADHESIVE2007-06-07
CRYOLIFE, INC.
BIOGLUE SURGICAL ADHESIVE2007-02-12
CRYOLIFE, INC.
PROPATCH SOFT TISSUE REPAIR MATRIX2006-11-22
CRYOLIFE, INC.
BIOGLUE SURGICAL ADHESIVE2006-07-26
CRYOLIFE, INC.
BIOGLUE SURGICAL ADHESIVE2006-04-13
CRYOLIFE, INC.
BIOGLUE SURGICAL ADHESIVE2006-01-20
CRYOLIFE, INC.
BIOGLUE SURGICAL ADHESIVE2005-12-08
CRYOLIFE, INC.
SOLARGEN 2100S LASER2004-12-23
CRYOLIFE, INC.
CRYOLIFE BIOGLUE SURGICAL ADHESIVE2004-10-20
CRYOLIFE, INC.
BIOGLUE SURGICAL ADHESIVE IN SYRINGE DELIVERY SYSTEM (MODEL BG3500)2004-05-03
CRYOLIFE, INC.
CARDIOGENESIS TMR2000 HOLMIUM LASER SYSTEM2002-12-03
CRYOLIFE, INC.
BIOGLUE SURGICAL ADHESIVE2002-10-08
CRYOLIFE, INC.
BIOGLUE SURGICAL ADHESIVE2002-07-29
CRYOLIFE, INC.
BIOGLUE SURGICAL ADHESIVE2001-12-03
CRYOLIFE, INC.
ECLIPSE TMR HOLMIUM LASER SYSTEM2001-11-29
CRYOLIFE, INC.
ECLIPSE TMR HOLMIUM LASER SYSTEM2001-11-01
CRYOLIFE, INC.
ECLIPSE TMR HOLMIUM LASER SYSTEM2000-12-08
CRYOLIFE, INC.
ECLIPSE TMR HOLMIUN LASER SYSTEM2000-03-22
CRYOLIFE, INC.
ECLIPSE TMR HOLMIUM LASER SYSTEM1999-09-17
CRYOLIFE, INC.
TMR HOLMIUM LASER SYSTEM1999-02-11

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