Company ยท US
Cryolife Inc
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2019. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
97recalls (0 in 12 months)
12recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MIE | Heart-Valve, Allograft | 78 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 10 |
| OHA | Heart Valve, More Than Minimally Manipulated Allograft | 5 |
| MUQ | Glue, Surgical, Arteries | 4 |
| FTM | Mesh, Surgical | 3 |
| LMO | 2 | |
| LWQ | Heart-Valve, Mechanical | 2 |
| PSQ | Intracardiac Patch Or Pledget, Biologically Derived | 2 |
| NJK | Valve, Pulmonary | 1 |
| NPT | Aortic Valve, Prosthesis, Percutaneously Delivered | 1 |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 14, 2019 | K183635 | PhotoFix Decellularized Bovine Pericardium Cryolife, Inc. | PSQ |
| Dec 4, 2017 | K172085 | PhotoFix Decellularized Bovine Pericardium Cryolife, Inc. | PSQ |
| Mar 9, 2017 | K162506 | PhotoFix Decellularized Bovine Pericardium Cryolife, Inc. | DXZ |
| Apr 3, 2014 | K132105 | PERCLOT TOPICAL Cryolife, Inc. | QSY |
| Jan 10, 2012 | K110581 | PROPATCH SOFT TISSUE REPAIR MATRIX Cryolife, Inc. | FTM |
| Sep 16, 2010 | K101587 | PROPATCH SOFT TISSUE REPAIR MATRIX Cryolife, Inc. | FTM |
| Jul 23, 2010 | K101866 | CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH Cryolife, Inc. | DXZ |
| May 25, 2010 | K092021 | CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) Cryolife, Inc. | OHA |
| Aug 7, 2009 | K091626 | CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH Cryolife, Inc. | DXZ |
| Feb 6, 2009 | K083106 | CRYOVALVE SG PULMONARY VALVE AND CONDUIT Cryolife, Inc. | OHA |
| Feb 7, 2008 | K033484 | HUMAN HEART VALVE, CRYOVALVE SG Cryolife, Inc. | OHA |
| Nov 22, 2006 | K061892 | PROPATCH SOFT TISSUE REPAIR MATRIX Cryolife, Inc. | FTM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2021 | CryoLife, Inc. BioGlue Surgical Adhesive, Model BG3510-5-G Terminated |
MUQ | None listed |
| Nov 10, 2020 | CryoLife, Inc. CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packagin Terminated |
DXZ | K101866 |
| Nov 10, 2020 | CryoLife, Inc. CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging Terminated |
OHA | K092021 |
| Jan 17, 2019 | CryoLife, Inc. On-X Aortic Heart Valve with Anatomic Sewing Ring
Product Usage:
The On-X Prosthetic Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart va Terminated |
LWQ | None listed |
| Sep 6, 2018 | CryoLife, Inc. CryoPatch SG Pulmonary Hemi-Artery, 1 graft Terminated |
DXZ | K091626 |
| Jun 4, 2018 | CryoLife, Inc. BioGlue Spreader Tip, 12mm, Sterile, RX Only.
Product Usage:
BioGlue is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in Terminated |
MUQ | None listed |
| May 14, 2018 | CryoLife, Inc. Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020 Terminated |
DXZ | K101866 |
| May 14, 2018 | CryoLife, Inc. Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO Terminated |
OHA | K092021 |
| May 19, 2017 | CryoLife, Inc. BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J Terminated |
MUQ | None listed |
| Nov 21, 2016 | CryoLife, Inc. CryoPatch SG Pulmonary Hemi-Artery Patch Terminated |
DXZ | K091626 |
| Jun 12, 2015 | CryoLife, Inc. On-X Prosthetic Heart Valve
Product Usage:
Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions Terminated |
LWQ | None listed |
| May 30, 2014 | CryoLife, Inc. BG3515-5 US 5mL BioGlue Surgical Adhesive.
BioGlue Surgical Adhesive (BioGlue) is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult p Terminated |
MUQ | None listed |
| Feb 12, 2014 | CryoLife, Inc. On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use.
Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position Terminated |
NPT | None listed |
| Jan 23, 2014 | CryoLife, Inc. Pulmonary Hemi-Artery SG
Used in heart surgery Terminated |
DXZ | K101866 |
| Mar 4, 2011 | CryoLife, Inc. Pulmonary Hemi-Artery SG
Used in heart surgery Terminated |
DXZ | K101866 |
| Mar 4, 2011 | CryoLife, Inc. Pulmonary Valve & Conduit SG
Used in heart surgery Terminated |
DXZ | K092021 |
| Feb 11, 2011 | CryoLife, Inc. Pulmonary Valve & Conduit SG
Used in heart surgery Terminated |
MIE | K083106 |
| Sep 1, 2008 | CryoLife, Inc. CryoValve, Pulmonary Valve & Conduit Terminated |
MIE | K033484 |
| Sep 1, 2008 | CryoLife, Inc. CryoValve, Aortic Valve & Conduit Terminated |
MIE | K033484 |
| Jun 7, 2007 | CryoLife, Inc. Aortic Valve & Conduit Terminated |
MIE | None listed |
| Jun 7, 2007 | CryoLife, Inc. CryoValve, Pulmonary Valve & Conduit Terminated |
MIE | None listed |
| Feb 4, 2006 | Cryolife Inc CryoValve, Pulmonary Valve & Conduit Terminated |
MIE | None listed |
| Feb 4, 2006 | Cryolife Inc CryoValve, Pulmonary Valve & Conduit SG Terminated |
MIE | None listed |
| Feb 4, 2006 | Cryolife Inc CryoValve, Aortic Valve &Conduit Terminated |
MIE | None listed |
| Feb 4, 2006 | Cryolife Inc CryoValve, Pulmonary Valve & Conduit Terminated |
MIE | None listed |
| Nov 30, 2005 | Cryolife Inc CryoValve, Pulmonary Valve & Conduit SG Terminated |
MIE | None listed |
| Nov 30, 2005 | Cryolife Inc CryoValve, Pulmonary Valve & Conduit Terminated |
MIE | None listed |
| Nov 30, 2005 | Cryolife Inc CryoValve, Pulmonary Valve Terminated |
MIE | None listed |
| Nov 30, 2005 | Cryolife Inc CryoValve, Aortic Valve & Conduit SG Terminated |
MIE | None listed |
| Nov 30, 2005 | Cryolife Inc CryoValve, Aortic Valve & Conduit Terminated |
MIE | None listed |
| Nov 30, 2005 | Cryolife Inc CryoValve, Aortic Valve Terminated |
MIE | None listed |
| Nov 30, 2005 | Cryolife Inc CryoValve, Alt Pulmonary Valve & Conduit Terminated |
MIE | None listed |
| Nov 30, 2005 | Cryolife Inc CryoValve, Alt Pulmonary Valve Terminated |
MIE | None listed |
| Nov 30, 2005 | Cryolife Inc CryoValve, Alt Aortic Valve & Conduit Terminated |
MIE | None listed |
| Oct 1, 2005 | Cryolife Inc CryoValve, Pulmonary Valve and Conduit Terminated |
MIE | None listed |
| Sep 28, 2005 | Cryolife Inc CryoValve, Pulmonary Valve & Conduit SG Terminated |
MIE | None listed |
| Sep 28, 2005 | Cryolife Inc CryoValve, Aortic Valve & Conduit SG Terminated |
MIE | None listed |
| Sep 28, 2005 | Cryolife Inc CryoValve, Pulmonary Valve & Conduit Terminated |
MIE | None listed |
| Jun 1, 2005 | Cryolife Inc Pulmonary Valve & Conduit Terminated |
MIE | None listed |
| Jun 1, 2005 | Cryolife Inc Aortic Valve & Conduit Terminated |
MIE | None listed |
| Apr 6, 2005 | Cryolife Inc CryoValve, Aortic Valve and Conduit Terminated |
MIE | None listed |
| Apr 6, 2005 | Cryolife Inc CryoValve, Aortic Valve & Conduit Terminated |
MIE | None listed |
| Apr 6, 2005 | Cryolife Inc CryoValve, Pulmonary Valve and Conduit Terminated |
MIE | None listed |
| Apr 6, 2005 | Cryolife Inc CryoValve, Aortic Valve & Conduit SG Terminated |
MIE | None listed |
| Apr 6, 2005 | Cryolife Inc CryoValve, Pulmonary Valve and Conduit Terminated |
MIE | None listed |
| Mar 10, 2005 | Cryolife Inc CryoValve, Aortic Valve and Conduit Terminated |
MIE | None listed |
| Mar 10, 2005 | Cryolife Inc CryoValve, Pulmonary Valve & Conduit Terminated |
MIE | None listed |
| Dec 8, 2004 | Cryolife Inc CryoValve, Pulmonary Valve & Conduit Terminated |
MIE | None listed |
| Nov 3, 2004 | Cryolife Inc Alt. Aortic Valve & Conduit Terminated |
MIE | None listed |
| Nov 3, 2004 | Cryolife Inc CryoValve, Aortic Valve & Conduit SG Terminated |
MIE | None listed |
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