CDRHNew
Date: April 25, 2013
The following new items were added to the CDRH web pages on April 24, 2013. Previous CDRH New Items can be found on the CDRHNew Page.
- Assay Migration Studies for In Vitro Diagnostic Devices - Guidance for Industry and FDA Staff
- Consumer Information on: DePuy Ceramax Ceramic Total Hip System - P070026S004
- Summary Information for: DePuy Ceramax Ceramic Total Hip System
- Class I Medical Device Recall: Engineered Medical Systems, Inc., SealFlex Single Port Ribbed Mask (Infant)
- Class I Medical Device Recall: GE Healthcare, Giraffe OmniBed and Giraffe Incubator
- Consumer Information on: TECNIS Toric 1-Piece Intraocular Lens (IOL) Models: ZCT150, ZCT225, ZCT300, ZCT400 - - P980040S039
- Summary Information for: TECNIS® Toric 1-Piece Intraocular Lens (IOL) and the TECNIS® Toric Calculator System
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