5 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Completed
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ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
FDA Enforcement
Class II
·Completed·Implant Direct Sybron Manufacturing, LLC·January 15, 2020
ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
FDA Enforcement
Class II
·Completed·Implant Direct Sybron Manufacturing, LLC·January 15, 2020
ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
FDA Recall
Completed
·Implant Direct Sybron Manufacturing, LLC·Product code NDP·November 28, 2018
ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
FDA Recall
Completed
·Implant Direct Sybron Manufacturing, LLC·Product code NDP·November 28, 2018
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
FDA Recall
Completed
·SynCardia Systems LLC·Product code LOZ·August 1, 2023