1,626 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi Reconstruction of the temporomandibular joint
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand Reconstruction of the temporomandibular joint
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /catalog # TYY-NNNNRM The TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System is intended to be used for the reconstruction of the temporomandibular joint. It is indicated for patients with one or more of the following conditions: Inflammatory arthritis involving the temporomandibular joint not responsive to other modalities of treatment; Recurrent fibrous and/or bony ankylosis not responsive to other modalities of treatment; Failed tissue graft; Failed alloplastic joint reconstruction; Loss of vertical mandibular height and/or occlusal relationship due to bone resorption, trauma, developmental abnormality, or pathologic lesion
FDA Recall
Terminated
·TMJ Solutions Inc·Product code LZD·March 12, 2018
Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand Reconstruction of the temporomandibular joint
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
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 Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·September 20, 2013
Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction of the temporomandibular joint
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Reconstruction of the temporomandibular joint
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
FDA Recall
Terminated
·Biomet Microfixation, LLC·Product code LZD·October 17, 2014
MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·April 17, 2013
VisuaLine Tricyclic Antidepressants: Six Dip (COC-THC-OPI-MET-BZD-OXD); Six Dip (COC-THC-OPI-MET-PCP-OXD); Eight DIP (COC-THC-OPI-MET-AMP-BAR-BZD-OXD); Nine Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA); Ten Dip X (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-TCA); Ten Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-OXD); Ten Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA-OXD); Five Dip (COC-THC-OPI-BZD-OXD); and Six Dip (CPC-THC-OPI-MET-AMP-OXD). Product is intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.
FDA Recall
Terminated
·Sun Biomedical Laboratories, Inc.·Product code DJR·May 28, 2008
MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code LNH·October 15, 2012
fMRI Hardware System VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and presented by a set of coil-mounted displays or by an in-room LCD monitor. - LCD Monitor Power supply (LPS) for LCD Monitor, Versions 1.0 and 1.1
FDA Enforcement
Class II
·Terminated·NordicNeuroLab AS·September 19, 2018