7 results
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20ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
FDA Recall
Terminated
·TYRX Inc.·Product code FTL·June 29, 2016
TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
FDA Recall
Terminated
·TYRX Inc.·Product code FTL·June 29, 2016
TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
FDA Recall
Terminated
·TYRX Inc.·Product code FTL·June 29, 2016
TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
FDA Enforcement
Class II
·Terminated·TYRX Inc.·August 24, 2016
TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
FDA Enforcement
Class II
·Terminated·TYRX Inc.·August 24, 2016
TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
FDA Enforcement
Class II
·Terminated·TYRX Inc.·August 24, 2016
Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths); 2. Erisma-LP Screwdriver; 3. Erisma-LP T20 Wrench; 4. Erisma-LPT20 Snap Fit Tightening Wrench
FDA Recall
Terminated
·Clariance Inc·Product code NKB·July 1, 2019