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.

USA

NEW YORK STOCK EXCHANGE

CRY

DUNS 119253177

FDA Registration(s)

• Registration Number: 1063481
• FEI Number: 3001451326
• Name: CryoLife, Inc.
• Owner & Operator: CryoLife, Inc.
• Contact Address: 1655 ROBERTS BLVD., N.W. --; Kennesaw GA 30144 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1655 Roberts Blvd NW ; KENNESAW, GA 30144 US
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMA P010003S039 CRYOLIFE, INC.	BioGlue® Surgical Adhesive	2021-12-09
PMA P010003S038 CRYOLIFE, INC.	BioGlue Surgical Adhesive	2021-07-23
PMN K183635 | PSQ CryoLife, Inc.	PhotoFix	2019-12-27
PMN K172085 | PSQ CryoLife, Inc.	PhotoFix	2019-12-27
PMN K162506 | DXZ CryoLife, Inc.	PhotoFix	2019-12-27
PMA P010003S037 CRYOLIFE, INC.	BioGlue Surgical Adhesive	2019-12-20
PMA P010003S036 CRYOLIFE, INC.	BioGlue Surgical Adhesive	2019-08-14
PMA P970029S039 CRYOLIFE, INC.	TMR Holmium Laser System	2019-05-02
GUDID 00877234000560 Cryolife, Inc.	PhotoFix Decellularized Bovine Pericardium PFP8X14	2019-04-08
PMN K183635 CryoLife, Inc.	PhotoFix Decellularized Bovine Pericardium	2019-02-14
PMA P010003S032 CRYOLIFE, INC.	Bioglue Surgical Adhesive	2019-01-04
PMA P010003S031 CRYOLIFE, INC.	BioGlue Surgical Adhesive	2018-11-01
GUDID 00877234000454 Cryolife, Inc.	CryoValve® SG Pulmonary Human Heart Valve SGPV10	2018-07-24
GUDID 00877234000447 Cryolife, Inc.	CryoValve® SG Pulmonary Human Heart Valve SGPV00	2018-07-24
PMA P970029S037 CRYOLIFE, INC.	TMR Holmium Laser System	2018-07-10
GUDID 10877234000260 Cryolife, Inc.	BioGlue Surgical Adhesive BGDTE-10	2018-07-06
GUDID 10877234000253 Cryolife, Inc.	BioGlue Surgical Adhesive BG3510-5-US	2018-07-06
GUDID 10877234000192 Cryolife, Inc.	BioGlue Surgical Adhesive BGST-16	2018-07-06
GUDID 10877234000178 Cryolife, Inc.	BioGlue Surgical Adhesive BGAT-27-SY	2018-07-06
GUDID 10877234000154 Cryolife, Inc.	BioGlue Surgical Adhesive BGAT-SY	2018-07-06
GUDID 00877234000485 Cryolife, Inc.	CryoPatch® SG Pulmonary Human Cardiac Branch Patch SGP020	2018-07-06
GUDID 00877234000478 Cryolife, Inc.	CryoPatch® SG Pulmonary Human Cardiac Trunk Patch SGP010	2018-07-06
GUDID 00877234000461 Cryolife, Inc.	CryoPatch® SG Pulmonary Human Cardiac Hemi-Artery Patch SGPH00	2018-07-06
GUDID 00877234000270 Cryolife, Inc.	Bioglue Surgical Adhesive BGDTE-27	2018-07-06
GUDID 00877234000249 Cryolife, Inc.	BioGlue Surgical Adhesive BG3515-5-US	2018-07-06
GUDID 00877234000232 Cryolife, Inc.	BioGlue Surgical Adhesive BG3502-5-US	2018-07-06
GUDID 00877234000188 Cryolife, Inc.	BioGlue Surgical Adhesive BGST-12	2018-07-06
GUDID 00877234000164 Cryolife, Inc.	BioGlue Surgical Adhesive BGAT-10-SY	2018-07-06
GUDID 00877234000119 Cryolife, Inc.	CardioGenesis HP-PRL5	2018-07-06
GUDID 00877234000102 Cryolife, Inc.	CardioGenesis HP-SG3	2018-07-06
GUDID 00877234000096 Cryolife, Inc.	CardioGenesis LSR-SG2100S	2018-07-06
PMA P010003S030 CRYOLIFE, INC.	BioGlue Surgical Adhesive	2018-06-25
GUDID 00877234000652 Cryolife, Inc.	PhotoFix Decellularized Bovine Pericardium PFP2X9	2018-05-31
GUDID 00877234000645 Cryolife, Inc.	PhotoFix Decellularized Bovine Pericardium PFP1X14	2018-05-31
GUDID 00877234000638 Cryolife, Inc.	PhotoFix Decellularized Bovine Pericardium PFP1X10	2018-05-31
GUDID 00877234000546 Cryolife, Inc.	PhotoFix Decellularized Bovine Pericardium PFP4X4	2018-05-31
GUDID 00877234000553 Cryolife, Inc.	PhotoFix Decellularized Bovine Pericardium PFP0.8X8	2018-03-29
GUDID 00877234000539 Cryolife, Inc.	PhotoFix Decellularized Bovine Pericardium PFP1X6	2018-03-29
GUDID 00877234000522 Cryolife, Inc.	PhotoFix Decellularized Bovine Pericardium PFP 6x8	2018-03-29
GUDID 00877234000423 Cryolife, Inc.	HeRO® Graft Adapter HERO 1004	2018-03-29
GUDID 00877234000089 Cryolife, Inc.	HeRO® Graft Accessory Component Kit HERO 1003	2018-03-29
GUDID 00877234000072 Cryolife, Inc.	HeRO® Graft Arterial Graft Component HERO 1002	2018-03-29
GUDID 00877234000065 Cryolife, Inc.	HeRO® Graft Venous Outflow Component HERO 1001	2018-03-29
PMA P010003S029 CRYOLIFE, INC.	BioGlue Surgical Adhesive	2018-01-03
PMN K172085 CryoLife, Inc.	PhotoFix Decellularized Bovine Pericardium	2017-12-04
PMA P010003S028 CRYOLIFE, INC.	BioGlue Surgical Adhesive	2017-09-12
PMA P970029S036 CRYOLIFE, INC.	TMR Holmium Laser System	2017-09-08
PMA P970029S034 CRYOLIFE, INC.	TMR Holmium Laser System	2017-08-31
PMA P010003S027 CRYOLIFE, INC.	BioGlue Surgical Adhesive	2017-08-21
PMA P970029S033 CRYOLIFE, INC.	CardioGenesis TMR System	2017-08-07
PMA P970029S035 CRYOLIFE, INC.	TMR Holmium Laser System	2017-07-28
PMN K162506 CryoLife, Inc.	PhotoFix Decellularized Bovine Pericardium	2017-03-09
PMA P010003S023 CRYOLIFE, INC.	BIOGLUE SURGICAL ADHESIVE	2017-02-10
PMA P010003S025 CRYOLIFE, INC.	BIOGLUE SURGICAL ADHESIVE	2016-09-08
PMA P970029S032 CRYOLIFE, INC.	CARDIOGENESIS TMR LASER SYSTEM	2016-08-23
MDM CryoLife, Inc.	Chordal Sizer	2016-08-18
DWS CryoLife, Inc.	On-X Instruments: handle and rotators	2016-08-17
PMA P010003S024 CRYOLIFE, INC.	BIOGLUE SURGICAL ADHESIVE	2016-07-07
PMA P970029S030 CRYOLIFE, INC.	TMR HOLMIUM LASER SYSTEM	2016-06-23
PMA P970029S029 CRYOLIFE, INC.	TMR HOLMIUM LASER SYSTEM	2016-06-21
PMN P000037 | LWQ CryoLife, Inc.	On-X Prosthetic Heart Valves	2016-05-13
PMN P000037 | LWQ CryoLife, Inc.	On-X Prosthetic Aortic Heart Valves with Anatomic Sewing Ring	2016-05-13
PMN P000037 | LWQ CryoLife, Inc.	On-X Conform-X Prosthetic Heart Valves	2016-05-13
PMN P000037 | LWQ CryoLife, Inc.	On-X AAP Ascending Aortic Prosthesis	2016-05-13
PMN K993288 | DXZ CryoLife, Inc.	PhotoFix Decellularized Bovine Pericardium	2016-05-13
PMN K141060 | PAW CryoLife, Inc.	Chord-X Loops	2016-05-13
PMN K121173 | PAW CryoLife, Inc.	Chord-X ePTFE Suture	2016-05-13
LXN CryoLife, Inc.	On-X Heart Valve Instruments	2016-05-13
DTI CryoLife, Inc.	On-X Heart Valve Instrumentation	2016-05-13
PMA P010003S022 CRYOLIFE, INC.	BIOGLUE SURGICAL ADHESIVE	2016-05-04
PMA P010003S021 CRYOLIFE, INC.	BIOGLUE SURGICAL ADHESIVE	2016-04-27
PMA P010003S020 CRYOLIFE, INC.	BIOGLUE SURGICAL ADHESIVE	2016-04-07
PMA P970029S028 CRYOLIFE, INC.	CARDIOGENESIS TMR SYSTEM	2015-12-22
PMA P010003S019 CRYOLIFE, INC.	BIOGLUE SURGICAL ADHESIVE	2015-09-24
PMA P970029S027 CRYOLIFE, INC.	PEARL 8.0 HANDPIECE	2015-04-03
PMN P970029 | MNO CryoLife, Inc.	TMR 2000	2014-11-05
PMN P970029 | MNO CryoLife, Inc.	SoloGrip III	2014-11-05
PMN P970029 | MNO CryoLife, Inc.	Solargen 2100S	2014-11-05
PMN P970029 | MNO CryoLife, Inc.	CardioGenesis	2014-11-05
PMA P970029S026 CRYOLIFE, INC.	CARDIOGENESIS TMR SYSTEM	2014-05-07
PMN K132105 | FRO CryoLife, Inc.	PerClot Topical Hemostatic Powder	2014-04-22
PMN K132105 CRYOLIFE, INC.	PERCLOT TOPICAL	2014-04-03
PMA P970029S025 CRYOLIFE, INC.	PEARL 8.0 HANDPIECE	2014-01-28
PMN K110581 | FTM CryoLife, Inc.	ProPatch Soft Tissue Repair Matrix	2013-12-11
PMN K101866 | DXZ CryoLife, Inc.	CryoPatch SG Pulmonary Human Cardiac Patch	2013-12-11
PMN K092021 | OHA CryoLife, Inc.	CryoValve SG Pulmonary Valve	2013-12-11
PMN K092021 | OHA CryoLife, Inc.	CryoValve SG Pulmonary Valve and Conduit	2013-12-11
PMA P010003S017 CRYOLIFE, INC.	BIOGLUE SURGICAL ADHESIVE	2013-09-06
PMA P970029S024 CRYOLIFE, INC.	CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM	2013-05-31
PMA P970029S022 CRYOLIFE, INC.	PEARL 8.0 HANDPIECE FOR TRANSMYOCARDIAL REVASCULARIZATION (TMR) WITH THE CARDIOGENESIS HOLMIUM: YAG LASER SYSTEM	2012-12-18
PMA P970029S021 CRYOLIFE, INC.	CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM	2012-09-13
PMA P970029S020 CRYOLIFE, INC.	CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM	2012-07-26
PMA P970029S019 CRYOLIFE, INC.	TMR2000 HOLMIUM LASER SYSTEM	2012-05-25
PMA P010003S016 CRYOLIFE, INC.	BIOGLUE SURGICAL ADHESIVE	2012-03-07
PMA P970029S014 CRYOLIFE, INC.	CARDIOGENESIS HOLMIUM TMR SYSTEM	2012-02-22
PMN K110581 CRYOLIFE, INC.	PROPATCH SOFT TISSUE REPAIR MATRIX	2012-01-10
PMA P970029S018 CRYOLIFE, INC.	CARDIOGENESIS TMR SYSTEM	2011-12-16
PMN K101587 CRYOLIFE, INC.	PROPATCH SOFT TISSUE REPAIR MATRIX	2010-09-16
PMN K101866 CRYOLIFE, INC.	CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH	2010-07-23
PMN K092021 CRYOLIFE, INC.	CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)	2010-05-25
PMA P010003S015 CRYOLIFE, INC.	BIOGLUE SURGICAL ADHESIVE	2010-05-12
PMA P970029S017 CRYOLIFE, INC.	CARDIOGENESIS TMR 2000 HOLMIUM LASER SYSTEM	2010-04-15
PMA P970029S015 CRYOLIFE, INC.	CARDIOGENESIS TMR SYSTEM	2009-10-20
PMN K091626 CRYOLIFE, INC.	CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH	2009-08-07
PMA P010003S014 CRYOLIFE, INC.	BIOGLUE SURGICAL ADHESIVE	2009-06-26
PMA P010003S013 CRYOLIFE, INC.	BIOGLUE SURGICAL ADHESIVE	2009-05-01
PMN K083106 CRYOLIFE, INC.	CRYOVALVE SG PULMONARY VALVE AND CONDUIT	2009-02-06
PMA P970029S013 CRYOLIFE, INC.	TMR HOLMIUM LASER SYSTEM	2008-12-30
PMA P970029S012 CRYOLIFE, INC.	SOLARGEN 2100S LASER	2008-09-11
PMA P010003S012 CRYOLIFE, INC.	BIOGLUE	2008-06-24
PMN K033484 CRYOLIFE, INC.	HUMAN HEART VALVE, CRYOVALVE SG	2008-02-07
PMA P970029S011 CRYOLIFE, INC.	TMR2000 HOLMIUM LASER SYSTEM	2007-11-05
PMN P010003 | MUQ CryoLife, Inc.	BioGlue (R) Surgical Adhesive	2007-11-02
PMA P010003S011 CRYOLIFE, INC.	BIOGLUE SURGICAL ADHESIVE	2007-10-18
PMA P010003S010 CRYOLIFE, INC.	BIOGLUE SURGICAL ADHESIVE	2007-06-07
PMA P010003S009 CRYOLIFE, INC.	BIOGLUE SURGICAL ADHESIVE	2007-02-12
PMN K061892 CRYOLIFE, INC.	PROPATCH SOFT TISSUE REPAIR MATRIX	2006-11-22
PMA P010003S008 CRYOLIFE, INC.	BIOGLUE SURGICAL ADHESIVE	2006-07-26
PMA P010003S006 CRYOLIFE, INC.	BIOGLUE SURGICAL ADHESIVE	2006-04-13
PMA P010003S005 CRYOLIFE, INC.	BIOGLUE SURGICAL ADHESIVE	2006-01-20
PMA P010003S007 CRYOLIFE, INC.	BIOGLUE SURGICAL ADHESIVE	2005-12-08
PMA P970029S009 CRYOLIFE, INC.	SOLARGEN 2100S LASER	2004-12-23
PMA P010003S004 CRYOLIFE, INC.	CRYOLIFE BIOGLUE SURGICAL ADHESIVE	2004-10-20
PMA P010003S003 CRYOLIFE, INC.	BIOGLUE SURGICAL ADHESIVE IN SYRINGE DELIVERY SYSTEM (MODEL BG3500)	2004-05-03
PMA P970029S006 CRYOLIFE, INC.	CARDIOGENESIS TMR2000 HOLMIUM LASER SYSTEM	2002-12-03
PMA P010003S002 CRYOLIFE, INC.	BIOGLUE SURGICAL ADHESIVE	2002-10-08
PMA P010003S001 CRYOLIFE, INC.	BIOGLUE SURGICAL ADHESIVE	2002-07-29
PMA P010003 CRYOLIFE, INC.	BIOGLUE SURGICAL ADHESIVE	2001-12-03
PMA P970029S008 CRYOLIFE, INC.	ECLIPSE TMR HOLMIUM LASER SYSTEM	2001-11-29
PMA P970029S007 CRYOLIFE, INC.	ECLIPSE TMR HOLMIUM LASER SYSTEM	2001-11-01
PMA P970029S005 CRYOLIFE, INC.	ECLIPSE TMR HOLMIUM LASER SYSTEM	2000-12-08
PMA P970029S003 CRYOLIFE, INC.	ECLIPSE TMR HOLMIUN LASER SYSTEM	2000-03-22
PMA P970029S001 CRYOLIFE, INC.	ECLIPSE TMR HOLMIUM LASER SYSTEM	1999-09-17
PMA P970029 CRYOLIFE, INC.	TMR HOLMIUM LASER SYSTEM	1999-02-11

Similar & Related FDA Registered Companies

• CRYOLIFE, INC.1655 Roberts Blvd., N.w.kennesaw, GA 30144 PMA NumberP970029 Supplement NumberS040 Date Received08/04/2022 Decision Date09/01/2022 Product Code MNO  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• CRYOLIFE, INC.1655 Roberts Blvd., N.w.kennesaw, GA 30144 PMA NumberP010003 Supplement NumberS040 Date Received04/29/2022 Decision Date05/25/2022 Product Code MUQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	0HSC8	CRYOLIFE, INC.
CAGE Code	0HSC8	CRYOLIFE, INC.
S.A.M. Registration	0HSC8 [119253177]	CRYOLIFE, INC.
SEC	0000784199	CRYOLIFE INC of FLORIDA