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Fujifilm Medical Systems U.S.A., Inc.

8 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000) recall (Z-0385-2018)Fujifilm Medical Systems U.S.A., Inc.2018-01-17
ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography System recall (Z-0386-2018)Fujifilm Medical Systems U.S.A., Inc.2018-01-17
Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures. recall (Z-2805-2015)Fujifilm Medical Systems U.S.A., Inc.2015-09-22
Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endosc recall (Z-2806-2015)Fujifilm Medical Systems U.S.A., Inc.2015-09-22
Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED- recall (Z-2778-2015)Fujifilm Medical Systems U.S.A., Inc.2015-09-17
FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Commu recall (Z-1611-2015)Fujifilm Medical Systems U.S.A., Inc.2015-05-14
Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Syn recall (Z-1612-2015)Fujifilm Medical Systems U.S.A., Inc.2015-05-14
Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammogra recall (Z-1585-2015)Fujifilm Medical Systems U.S.A., Inc.2015-05-06

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