CDRHNew
Date: December 29, 2014
The following new items were added to the CDRH web pages on December 24, 2014. Previous CDRH New Items can be found on the CDRHNew Page.
- Federal Register: Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of Ebola Zaire Virus; Availability
- Class I Medical Device Recall: Customed Inc., Surgical Convenience Packs - Compromised Sterility Due to Multiple Problems
- Emergency Use Authorizations (December 24 - Added LightMix® Ebola Zaire rRT-PCR Test)
- Federal Register: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
- Class I Medical Device Recall: Heart Sync, Multi-function Defibrillation Electrodes Will Not Work with Philips FR3 and FRx AEDs
- Federal Register: Medical Device Classification Procedures; Reclassification Petition: Content and Form; Technical Amendment
- Meeting Notice: February 27, 2015 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee