CDRH New - December 17, 2021

U.S. Food and Drug Administration sent this bulletin at 12/17/2021 09:53 AM EST

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U.S. Food and Drug Administration - CDRH New

December 17, 2021

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on December 16, 2021. To view listings for other dates, see CDRH New - News and Updates.

Class I Recall: Getinge/Datascope/Maquet Recalls Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Due to Reports of Fluid Leaks
Nucleic Acid Based Tests (Updated)
24 Hour Summary and Presentations for December 10, 2021 Neurological Devices Panel of the Medical Devices Advisory Committee Meeting
Federal Register: Requests for Nominations: Voting Members on Public Advisory Panels of the Medical Devices Advisory Committee
Federal Register: Medical Devices: General and Plastic Surgery Devices; Classification of the Manual Percutaneous Surgical Set Assembled in the Abdomen

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