CRYOLIFE, INC

FDA Filings

This page includes the latest FDA filings for CRYOLIFE, INC. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
CryoLife, Inc.
PhotoFix Decellularized Bovine Pericardium2019-02-14
CryoLife, Inc.
PhotoFix Decellularized Bovine Pericardium2017-12-04
CRYOLIFE, INC.
CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH2010-07-23
CRYOLIFE, INC.
CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)2010-05-25

Latest Premarket Applications

PMAManufacturerDevice NameDate
CRYOLIFE, INC.
BioGlue Surgical Adhesive2019-08-14
CRYOLIFE, INC.
TMR Holmium Laser System2019-05-02
CRYOLIFE, INC.
Bioglue Surgical Adhesive2019-01-04
CRYOLIFE, INC.
BioGlue Surgical Adhesive2018-11-01
CRYOLIFE, INC.
TMR Holmium Laser System2018-07-10
CRYOLIFE, INC.
BioGlue Surgical Adhesive2018-06-25
CRYOLIFE, INC.
BioGlue Surgical Adhesive2018-01-03
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.
BIOGLUE SURGICAL ADHESIVE2017-02-10
CRYOLIFE, INC.
BIOGLUE SURGICAL ADHESIVE2016-09-08
CRYOLIFE, INC.
CARDIOGENESIS TMR LASER SYSTEM2016-08-23
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.
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.
CARDIOGENESIS TMR SYSTEM2014-05-07
CRYOLIFE, INC.
PEARL 8.0 HANDPIECE2014-01-28
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

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
PhotoFix Decellularized Bovine Pericardium
Cryolife, Inc.2019-04-08
CryoValve® SG Pulmonary Human Heart Valve
Cryolife, Inc.2018-07-24
CryoValve® SG Pulmonary Human Heart Valve
Cryolife, Inc.2018-07-24
CryoPatch® SG Pulmonary Human Cardiac Branch Patch
Cryolife, Inc.2018-07-06
CryoPatch® SG Pulmonary Human Cardiac Trunk Patch
Cryolife, Inc.2018-07-06
CryoPatch® SG Pulmonary Human Cardiac Hemi-Artery
Cryolife, Inc.2018-07-06
Bioglue Surgical Adhesive
Cryolife, Inc.2018-07-06
BioGlue Surgical Adhesive
Cryolife, Inc.2018-07-06
BioGlue Surgical Adhesive
Cryolife, Inc.2018-07-06
BioGlue Surgical Adhesive
Cryolife, Inc.2018-07-06
BioGlue Surgical Adhesive
Cryolife, Inc.2018-07-06
BioGlue Surgical Adhesive
Cryolife, Inc.2018-07-06
BioGlue Surgical Adhesive
Cryolife, Inc.2018-07-06
BioGlue Surgical Adhesive
Cryolife, Inc.2018-07-06
BioGlue Surgical Adhesive
Cryolife, Inc.2018-07-06
BioGlue Surgical Adhesive
Cryolife, Inc.2018-07-06
CardioGenesis
Cryolife, Inc.2018-07-06
CardioGenesis
Cryolife, Inc.2018-07-06
CardioGenesis
Cryolife, Inc.2018-07-06
PhotoFix Decellularized Bovine Pericardium
Cryolife, Inc.2018-05-31
PhotoFix Decellularized Bovine Pericardium
Cryolife, Inc.2018-05-31
PhotoFix Decellularized Bovine Pericardium
Cryolife, Inc.2018-05-31
PhotoFix Decellularized Bovine Pericardium
Cryolife, Inc.2018-05-31
PhotoFix Decellularized Bovine Pericardium
Cryolife, Inc.2018-03-29
PhotoFix Decellularized Bovine Pericardium
Cryolife, Inc.2018-03-29
PhotoFix Decellularized Bovine Pericardium
Cryolife, Inc.2018-03-29
HeRO® Graft Adapter
Cryolife, Inc.2018-03-29
HeRO® Graft Accessory Component Kit
Cryolife, Inc.2018-03-29
HeRO® Graft Arterial Graft Component
Cryolife, Inc.2018-03-29
HeRO® Graft Venous Outflow Component
Cryolife, Inc.2018-03-29

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