19 results
·
57ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
×
Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma.
FDA Enforcement
Class II
·Terminated·Biomet Microfixation, LLC·September 14, 2016
Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600
FDA Enforcement
Class II
·Terminated·Biomet Microfixation, LLC·May 24, 2017
Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ replacement system is a two-component system comprised of mandibular condyle and a glenoid fossa components. Both components are available in multiple stock sizes as right and left specific designs and are attached to the bones by screws.
FDA Enforcement
Class II
·Terminated·Biomet Microfixation, LLC·September 10, 2014
Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
FDA Enforcement
Class II
·Terminated·Biomet Microfixation, LLC·December 17, 2014
Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
FDA Enforcement
Class II
·Terminated·Biomet Microfixation, LLC·December 17, 2014
Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.
FDA Enforcement
Class II
·Terminated·Biomet Microfixation, LLC·October 28, 2015
Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
FDA Enforcement
Class II
·Terminated·Biomet Microfixation, LLC·December 17, 2014
Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
FDA Enforcement
Class II
·Terminated·Biomet Microfixation, LLC·December 17, 2014
Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand Reconstruction of the temporomandibular joint
FDA Enforcement
Class II
·Terminated·Biomet Microfixation, LLC·December 17, 2014
Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction of the temporomandibular joint
FDA Enforcement
Class II
·Terminated·Biomet Microfixation, LLC·December 17, 2014
Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
FDA Enforcement
Class II
·Terminated·Biomet Microfixation, LLC·December 17, 2014
Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.
FDA Enforcement
Class II
·Terminated·Biomet Microfixation, LLC·October 28, 2015
Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
FDA Enforcement
Class II
·Terminated·Biomet Microfixation, LLC·December 17, 2014
Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi Reconstruction of the temporomandibular joint
FDA Enforcement
Class II
·Terminated·Biomet Microfixation, LLC·December 17, 2014
Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
FDA Enforcement
Class II
·Terminated·Biomet Microfixation, LLC·December 17, 2014
Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand Reconstruction of the temporomandibular joint
FDA Enforcement
Class II
·Terminated·Biomet Microfixation, LLC·December 17, 2014
Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
FDA Enforcement
Class II
·Terminated·Biomet Microfixation, LLC·December 17, 2014
Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Reconstruction of the temporomandibular joint
FDA Enforcement
Class II
·Terminated·Biomet Microfixation, LLC·December 17, 2014
Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
FDA Enforcement
Class II
·Terminated·Biomet Microfixation, LLC·December 17, 2014