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Fujifilm Medical System USA, Inc.

5 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray ge recall (Z-1642-2014)Fujifilm Medical System USA, Inc.2014-05-21
Synapse Software Versions 3.1.0 and 3.1.1 used with the Fuji Synapse PACS recall (Z-0622-06)Fujifilm Medical System USA, Inc.2006-03-15
Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and recall (Z-0055-05)Fujifilm Medical System USA, Inc.2004-10-28
Fuji Flash IIP and CR-IR346CL Consoles recall (Z-0993-04)Fujifilm Medical System USA, Inc.2004-07-20
Synapse Version 2.2.1 and 2.3.1 software recall (Z-0932-03)Fujifilm Medical System USA, Inc.2003-06-12

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