Aziyo Biologics Inc

FDA Filings

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

FDA Registration(s)
Registration Number3005619880
FEI Number3005619880
NameAZIYO BIOLOGICS, INC.
Owner & OperatorAziyo Biologics, Inc.
Contact Address1100 Old Ellis Road Suite 1200
Roswell GA 30076 US
Official Correspondent
  • Andrew M Green
  • 1-470-5144085-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1100 Old Ellis Rd Suite 1200
Roswell, GA 30076 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



Registration Number2950190
FEI Number1000100754
NameAziyo Biologics
Owner & OperatorAziyo Biologics, Inc.
Contact Address1100 Old Ellis Road Suite 1200
Roswell GA 30076 US
Official Correspondent
  • Andrew M Green
  • 1-470-5144085-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address880 Harbour Way, South Suite 100
Richmond, CA 94804 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
AZIYO BIOLOGICS, INC.
EluPro Antibiotic-Eluting BioEnvelope 2024-09-16
AZIYO BIOLOGICS, INC.
EluPro Antibiotic-Eluting BioEnvelope 2024-09-16
AZIYO BIOLOGICS, INC.
Biotronik BioEnvelope 2021-02-05
AZIYO BIOLOGICS, INC.
Biotronik BioEnvelope 2021-02-05
AZIYO BIOLOGICS, INC.
Biotronik BioEnvelope 2021-02-05
AZIYO BIOLOGICS, INC.
Biotronik BioEnvelope 2021-02-05
AZIYO BIOLOGICS, INC.
Biotronik BioEnvelope 2021-02-05
Aziyo Biologics, Inc.
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra Large), CanGaroo Enevlope (extra Extra Large) (SubQ)2020-06-15
Aziyo Biologics, Inc.
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra Large), CanGaroo Envelope (extra Extra Large) (SubQ)2019-10-21
AZIYO BIOLOGICS, INC.
CanGaroo Envelope 2019-03-11
AZIYO BIOLOGICS, INC.
Tyke, Patch, Pledget and Intracardiac 2019-03-11
AZIYO BIOLOGICS, INC.
CanGaroo Envelope 2019-03-06
AZIYO BIOLOGICS, INC.
CanGaroo Envelope 2019-03-06
AZIYO BIOLOGICS, INC.
CanGaroo Envelope 2019-03-06
AZIYO BIOLOGICS, INC.
CanGaroo Envelope 2019-03-06
AZIYO BIOLOGICS, INC.
VasCure for Vascular Repair 2019-03-01
AZIYO BIOLOGICS, INC.
VasCure for Vascular Repair 2019-03-01
AZIYO BIOLOGICS, INC.
VasCure for Carotid Repair 2019-03-01
AZIYO BIOLOGICS, INC.
VasCure for Carotid Repair 2019-03-01
AZIYO BIOLOGICS, INC.
ProxiCor for Cardiac Tissue Repair 2019-03-01
AZIYO BIOLOGICS, INC.
ProxiCor for Cardiac Tissue Repair 2019-03-01
AZIYO BIOLOGICS, INC.
ProxiCor for Pericardial Closure 2019-03-01
AZIYO BIOLOGICS, INC.
ProxiCor for Pericardial Closure 2019-03-01
Aziyo Biologics, Inc.
CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra Large)2018-11-15
Aziyo Biologics [Aziyo Biologics, Inc.]
ViBone GraftGun Viable Bone Matrix MIS Cartridge2018-08-12
Aziyo Biologics, Inc.
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra Large)2017-10-25
AZIYO BIOLOGICS, INC.
Tyke2017-06-27
AZIYO BIOLOGICS, INC.
VasCure for Vascular Repair2017-06-27
AZIYO BIOLOGICS, INC.
ECM for Vascular Repair2017-06-27
AZIYO BIOLOGICS, INC.
CanGaroo Envelope2017-06-27
AZIYO BIOLOGICS, INC.
CanGaroo ECM Envelope2017-06-27
AZIYO BIOLOGICS, INC.
BioEnvelope2017-06-27
AZIYO BIOLOGICS, INC.
VasCure for Carotid Repair2017-06-27
AZIYO BIOLOGICS, INC.
ECM for Carotid Repair2017-06-27
AZIYO BIOLOGICS, INC.
ProxiCor for Cardiac Tissue Repair2017-06-27
AZIYO BIOLOGICS, INC.
ECM for Cardiac Tissue Repair2017-06-27
AZIYO BIOLOGICS, INC.
ProxiCor for Pericardial Closure2017-06-27
AZIYO BIOLOGICS, INC.
ECM for Pericardial Closure2017-06-27

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