Date: December 12, 2016
The following new items were added to the CDRH web pages on December 9, 2016. Previous CDRH New Items can be found on the CDRHNew Page.
- Class I Medical Device Recall: Centurion Recalls Multi-Med Single Lumen Catheters due to Excess Material that May Split or Separate
- Emergency Use Authorizations: Zika ELITe MGB® Kit U.S. (ELITechGroup Inc. Molecular Diagnostics)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150004, DEN150037, DEN150049 added)
- PMA Final Decisions for November 2016