Data / Medical devices / United States / Artivion, Inc.
Artivion, Inc.: FDA-registered device maker in Kennesaw, GA, United States, 8 510(k) clearances and 3 PMA approvals
Artivion, Inc. is registered with the FDA (registration 1063481) in Kennesaw, GA, United States. It lists 13 device types. The FDA files 8 510(k) clearances and 3 PMA approvals under its listings, the newest dated June 26, 2026. 61 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1063481
- FEI number
- 3001451326
- Address
- 1655 Roberts Blvd NW, Kennesaw, GA, United States, 30144
- Owner or operator
- Artivion, Inc. (9003683)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- November 2, 2007
- Registered through
- 2026
- Brand names listed
- AMDS Hybrid Prosthesis, BioGlue (R) Surgical Adhesive, Chord-X Loops, Chord-X ePTFE Suture, Chordal Sizer, CryoPatch SG Pulmonary Human Cardiac Patch, CryoValve® SG Pulmonary Valve, CryoValve® SG Pulmonary Valve and Conduit and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 2, 2025 | K252059 | CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) | OHA | Substantially Equivalent | Artivion, Inc. | accessdata.fda.gov |
| February 14, 2019 | K183635 | PhotoFix Decellularized Bovine Pericardium | PSQ | Substantially Equivalent | Cryolife, Inc. | accessdata.fda.gov |
| December 4, 2017 | K172085 | PhotoFix Decellularized Bovine Pericardium | PSQ | Substantially Equivalent | Cryolife, Inc. | accessdata.fda.gov |
| March 9, 2017 | K162506 | PhotoFix Decellularized Bovine Pericardium | DXZ | Substantially Equivalent | Cryolife, Inc. | accessdata.fda.gov |
| June 6, 2014 | K141060 | CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT | PAW | Substantially Equivalent | On-X Life Technologies, Inc. | accessdata.fda.gov |
| August 16, 2012 | K121173 | CHORD-X EPTFE SUTURE | PAW | Substantially Equivalent | On-Xlifetechnologies | accessdata.fda.gov |
| July 23, 2010 | K101866 | CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH | DXZ | Substantially Equivalent | Cryolife, Inc. | accessdata.fda.gov |
| December 29, 1999 | K993288 | SULZER CARBOMEDICS CARDIOFIX PERICARDIUM | DXZ | Substantially Equivalent | Sulzer Carbomedics, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| June 26, 2026 | P250055 | AMDS Hybrid Prosthesis | QSK | 0 | June 26, 2026 | accessdata.fda.gov |
| December 3, 2001 | P010003 | BIOGLUE SURGICAL ADHESIVE | MUQ | 40 | July 15, 2026 | accessdata.fda.gov |
| May 30, 2001 | P000037 | ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA | LWQ | 65 | August 4, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 18, 2026 | 100012 | Not yet classified | Open, Classified | CryoPatch SynerGraft (SG) Pulmonary Human Cardiac Patch, Model: SGP010 | A cryopreserved pulmonary human cardiac patch, taken from a 64-year-old human donor, was outside the cardiac tissue donor age specification of newborn to 60 years. The patch was implanted, and due to limitations of long-term in vivo data, the possibility of premature graft dysfunction cannot be excluded. | accessdata.fda.gov |
| May 28, 2024 | 94909 | Class II | Ongoing | CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology. | Grafts were found to have been approved, released, shipped and implanted with an invalid test results. | accessdata.fda.gov |
| March 6, 2024 | 94250 | Class II | Ongoing | CryoValve SG Cryopreserved Pulmonary Human Heart Valve | The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus. | accessdata.fda.gov |
| October 7, 2021 | 88929 | Class II | Terminated | BioGlue Surgical Adhesive, Model BG3510-5-G | Product is not approved for use in the EU and should not have been distributed in the EU. | accessdata.fda.gov |
| November 10, 2020 | 86890 | Class II | Terminated | 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 system not only withs | On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processing allografts subjected to the recall. | accessdata.fda.gov |
| January 17, 2019 | 82044 | Class II | Terminated | 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 valves in the aortic po | On-X Valve was mislabeled with the incorrect serial number. | accessdata.fda.gov |
| September 6, 2018 | 81095 | Class II | Terminated | CryoPatch SG Pulmonary Hemi-Artery, 1 graft | The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is 4.5cm. | accessdata.fda.gov |
| June 4, 2018 | 80276 | Class II | Terminated | 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 open surgical repair | The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorrectly applied to the Syringe Applicator Tip pouches and Syringe Spreader Tip pouches were not included in the boxes. | accessdata.fda.gov |
| May 14, 2018 | 80199 | Class II | Terminated | Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO | Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine. | accessdata.fda.gov |
| May 19, 2017 | 77369 | Class II | Terminated | BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J | The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002. | accessdata.fda.gov |
| November 21, 2016 | 82380 | Class II | Terminated | CryoPatch SG Pulmonary Hemi-Artery Patch | The device is recalled due to donor ineligibility of released human tissue. The firm received information that the tissue donor's blood culture tested positive for Enterobacter cloacae. | accessdata.fda.gov |
| June 12, 2015 | 77565 | Class II | Terminated | 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 | Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring instead of an Anatomic Sewing Ring. | accessdata.fda.gov |
| April 25, 2014 | 68150 | Class II | Terminated | 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 patients in open surgic | Serum albumin component monomer failed to meet internally established end of shelf-life specification. | accessdata.fda.gov |
| February 12, 2014 | 77728 | Class II | Terminated | 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 in cases that involve a | Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients. | accessdata.fda.gov |
| November 22, 2013 | 67182 | Class II | Terminated | Pulmonary Hemi-Artery SG Used in heart surgery | Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the administration of normal saline to the donor prior to death. | accessdata.fda.gov |
| May 1, 2011 | 66046 | Class II | Terminated | Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The device is indicated for use in the treatment of patients with angina (Canadian Cardiovascular Society Class 4) refractory to medical treatment and seco | Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces. | accessdata.fda.gov |
| February 17, 2011 | 57974 | Not yet classified | Terminated | Pulmonary Valve & Conduit SG Used in heart surgery | Staphylococcus aureus (not methicillin resistant) identified in companion tissue. | accessdata.fda.gov |
| January 7, 2011 | 57730 | Not yet classified | Terminated | Pulmonary Valve & Conduit SG Used in heart surgery | A pre-processing culture performed on a companion allograft (Aortic Valve & Conduct SG) tested positive for Staphylococcus aureus. | accessdata.fda.gov |
| March 26, 2008 | 47517 | Not yet classified | Terminated | CryoValve, Aortic Valve & Conduit | Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed. | accessdata.fda.gov |
| April 17, 2007 | 37876 | Not yet classified | Terminated | CryoValve, Pulmonary Valve & Conduit | Donor tissue was released prior to information received regarding a pericardial effusion. | accessdata.fda.gov |
| January 27, 2006 | 34502 | Not yet classified | Terminated | CryoValve, Pulmonary Valve & Conduit | Additional serological testing performed after distribution indicates the donor has a past Hepatitis B infection. | accessdata.fda.gov |
| May 17, 2005 | 32127 | Not yet classified | Terminated | Aortic Valve & Conduit | Subsequent to tissue release, CryoLife received new information related to the donor time of death, which caused the donor to no longer meet CryoLife's acceptance criteria for warm ischemic time. | accessdata.fda.gov |
| January 12, 2005 | 30971 | Not yet classified | Terminated | CryoValve, Pulmonary Valve and Conduit | During a retrospective review CryoLife's Medical Director identified pre-processing and incoming bioburden cultures of the heart tissue, which detected Staphylococcus aureas. | accessdata.fda.gov |
| December 17, 2004 | 31140 | Not yet classified | Terminated | CryoValve, Aortic Valve & Conduit SG | During a retrospective review, CryoLife noted that the donor tissue exceeded the acceptable warm ischemic time when utilizing the 'Last Seen Alive' time in their calculation. | accessdata.fda.gov |
| December 17, 2004 | 30803 | Not yet classified | Terminated | CryoValve, Pulmonary Valve & Conduit | Records noted that the infant donor's mother had tested positive for Hepatitis B. | accessdata.fda.gov |
| December 2, 2004 | 31243 | Not yet classified | Terminated | CryoValve, Aortic Valve and Conduit | An incorrect lot number was entered in the production record for the solution in which this allograft was packaged. | accessdata.fda.gov |
| July 28, 2004 | 30552 | Not yet classified | Terminated | CryoValve, Pulmonary Valve & Conduit | CryoLife received information stating that the tissue donation was deferred due to possible Hepaititis C suspected by the MD. | accessdata.fda.gov |
| July 15, 2004 | 30191 | Not yet classified | Terminated | CryoValve, Pulmonary Valve & Conduit | A pre-implant swab culture of the aortic valve, which was procured from the same donor, was positive for Methicillin resistant Staphyococcus aureus. | accessdata.fda.gov |
| July 1, 2004 | 29501 | Not yet classified | Terminated | CryoValve, Aortic Valve | The sterilization cycle for the instruments used during the procurement of the tissue from the donor had expired. | accessdata.fda.gov |
| June 17, 2004 | 29451 | Not yet classified | Terminated | CryoValve Pulmonary Valve SG | The Amphotericin B Intermediate (G10030), one of the components of the antimicrobial solution, had reached expiration at the time it was utilized to manufacture the Combo Antibiotic Stock Solution (G10070). | accessdata.fda.gov |
| May 6, 2004 | 30233 | Not yet classified | Terminated | CryoValve, Pulmonary Valve & Conduit | During a retrospective review, CryoLife identified positive microbiological culture results for donor tissues associated with various allografts. | accessdata.fda.gov |
| May 6, 2004 | 30218 | Not yet classified | Terminated | CryoValve, Pulmonary Valve & Conduit | CryoLife conducted a retrospective review which revealed the sterilization cycle of instruments used during processing of various tissues could not be confirmed as acceptable. | accessdata.fda.gov |
| April 19, 2004 | 32841 | Not yet classified | Terminated | CryoValve, Pulmonary Valve & Conduit | This recall was initiated as part of the firm's retrospection review of tissues associated with complaints of alleged recipient infection. | accessdata.fda.gov |
| April 12, 2004 | 29960 | Not yet classified | Terminated | CryoValve, Conduit and Pulmonary Valve and Conduit | CryoLife received information regarding a positive culture for Group A Streptococcus infection in a recipient of tissue procured from the attached donor. | accessdata.fda.gov |
| March 24, 2004 | 28710 | Not yet classified | Terminated | CryoValve, Pulmonary Valve & Conduit | The donor of the tissue had a viral syndrome at the time of death. | accessdata.fda.gov |
| February 25, 2004 | 28467 | Not yet classified | Terminated | CryoValve Aortic Valve | A retrospective review of donor files conducted by CryoLife revealed an expired solution had been used during processing of the associated tissues. | accessdata.fda.gov |
| February 20, 2004 | 28726 | Not yet classified | Terminated | CryoValve, Aortic Valve & Conduit | Microorganisms were detected in donor tissue associated with this allograft, specifically Aeormonas hydrophila. | accessdata.fda.gov |
| February 18, 2004 | 28558 | Not yet classified | Terminated | CryoValve, Aortic Valve and Conduit | CryoLife received additional information after release of tissue indicating the donor had repeatedly reactive test results for antibody to HCV (EIA) in 1995. | accessdata.fda.gov |
| January 30, 2004 | 28764 | Not yet classified | Terminated | CryoValve, Pulmonary Valve and Conduit | CryoLife was notified by the Tennessee Department of Health, that a recipient had contracted a Group A Streptococcus infection from orthopedic tissue originating from the same donor as CryoLife donor 69347. | accessdata.fda.gov |
| January 26, 2004 | 32905 | Not yet classified | Terminated | CryoValve, Pulmonary Valve and Conduit | Mislabeling; An allograft labeled as an aortic valve & conduit, actually contained a pulmonary valve and conduit. | accessdata.fda.gov |
| January 16, 2004 | 28176 | Not yet classified | Terminated | Synergraft CryoValve, Aortic Valve & Conduit SG | Microorganisms were detected in associated tissue. | accessdata.fda.gov |
| December 10, 2003 | 28345 | Not yet classified | Terminated | CryoValve Pulmonary Valve and Conduit | As part of this ongoing retrospective review, CryoLife has identified a donor who does not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered. | accessdata.fda.gov |
| November 19, 2003 | 32850 | Not yet classified | Terminated | CryoValve, Alt Aortic Valve & Conduit | Previously released tissues no longer meet CryoLife's enhanced suitability release criteria because donors possessed a positive post processing microbiological culture of 'potentially pathogenic' organisms. | accessdata.fda.gov |
| November 10, 2003 | 27949 | Not yet classified | Terminated | CryoValve, Pulmonary Valve & Conduit | The firm received additional information from the procurement agency indicating that Yeast was detected in the musculoskeletal procurement cultures for the hemi pelvis. | accessdata.fda.gov |
| November 4, 2003 | 27664 | Not yet classified | Terminated | CryoValve Pulmonary Valve & Conduct | CryoLife received information that an allograft associated with the donor had been linked to a complaint of an alleged positive pre-implant culture. Specifically Clostridium baratii was detected on the pre-implant culture performed at the implanting hospital site. | accessdata.fda.gov |
| September 25, 2003 | 27390 | Not yet classified | Terminated | CryoValve, Pulmonary Heart Valve | Additional information obtained from the Outside Tissue Procurement Organization indicated that the donor's attending physician stated that the patient had pneumonia and it possibly might have been a systemic infection. | accessdata.fda.gov |
| September 10, 2003 | 27280 | Not yet classified | Terminated | CryoValve, Aortic & Conduit | Firm received additional information from the procurement agency indicating that the donor's serological test sample may have been sufficiently diluted by transfusion/infusion to invalidate the HIV and Hepatitis B and C screening test results. | accessdata.fda.gov |
| August 18, 2003 | 27051 | Not yet classified | Terminated | CryoValve, Pulmonary Valve & Conduit SG | The heart valve procurement exceeded the warm ischemic time criteria. | accessdata.fda.gov |
| July 10, 2003 | 26693 | Not yet classified | Terminated | CryoValve, Synegraft Pulmonary Valve & Conduit | Human tissue for transplantation, which was associated with a donor whose pre-processing culture detected microorganisms, was distributed. | accessdata.fda.gov |
| May 23, 2003 | 26422 | Not yet classified | Terminated | CryoValve Pulmonary Valve & Conduit. | Microorganisms detected in associated allografts. | accessdata.fda.gov |
| May 5, 2003 | 26319 | Not yet classified | Terminated | CryoValve Allograft, Aortic Valve & Conduit | Donor of distributed allograft was diagnosed with dilated/ischemic cardiomyopathy. | accessdata.fda.gov |
| May 5, 2003 | 26286 | Not yet classified | Terminated | CryoValve Allograft, Pulmonary Heart valve & Conduit. | Microorganisms were detected in associated allografts after initial release of donor. | accessdata.fda.gov |
| April 30, 2003 | 26205 | Not yet classified | Terminated | CryoValve Allograft, Heart valve | Microorganisms were detected in associated allografts. | accessdata.fda.gov |
| April 1, 2003 | 26985 | Not yet classified | Terminated | CryoValve Heart Valve | CryoLife initiated a retrospective review per FDA request, to insure that current regulatory guidelines for donor blood testing have been met for certain donors. | accessdata.fda.gov |
| March 19, 2003 | 25832 | Not yet classified | Terminated | CryoValve Heart-valve, allograft | The recipient of one of the kidneys from the donor has developed renal cell carcinoma. | accessdata.fda.gov |
| February 24, 2003 | 25819 | Not yet classified | Terminated | CryoValve Allograft, Heart valve. | Pre-processing cultures detected certain microorganisms in donor tissue. | accessdata.fda.gov |
| February 18, 2003 | 25635 | Not yet classified | Terminated | CryoValve Allograft, heart valve | Microorganisms were detected in distributed donor tissue. | accessdata.fda.gov |
| February 4, 2003 | 25772 | Not yet classified | Terminated | Heart-valve, allograft | Donor of aortic valve had procurement cultures that were positive for E-coli. | accessdata.fda.gov |
| February 4, 2003 | 25675 | Not yet classified | Terminated | CryoValve Allograft, Heart valve | Microorganisms were detected in distributed allografts. | accessdata.fda.gov |
| January 30, 2003 | 25595 | Not yet classified | Terminated | CryoValve Allograft heart valve | An allograft associated with this donor has been linked to an alleged infection. | accessdata.fda.gov |
| January 23, 2003 | 25593 | Not yet classified | Terminated | CryoValve Allograft heart valve | An allograft associated with this donor has been linked to an alleged infection. | accessdata.fda.gov |
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Updated October 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.