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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 3 of 3 Results
510(K) Number: K110729
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Product Description
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Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), gen... 2 02/20/2018 Fujifilm Medical Systems U.S.A., Inc.
FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) ... 2 08/30/2016 Fujifilm Medical Systems U.S.A., Inc.
Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography sy... 2 05/06/2015 Fujifilm Medical Systems U.S.A., Inc.
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