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Fenwal Inc

5 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural aphe recall (Z-1254-2023)Fenwal Inc2023-03-15
Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis recall (Z-1255-2023)Fenwal Inc2023-03-15
VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product U recall (Z-2064-2019)Fenwal Inc2019-08-12
Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigil recall (Z-2065-2019)Fenwal Inc2019-08-12
AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator recall (Z-1523-2013)Fenwal Inc2013-06-08

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Every clearance here is in the API, with alerts when new ones post.