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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K133972
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ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FD... 2 02/20/2018 Fujifilm Medical Systems U.S.A., Inc.
ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Asp... 2 01/17/2018 Fujifilm Medical Systems U.S.A., Inc.
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