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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K003214
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Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 7014... 2 08/14/2020 FEI # 2429304
Olympus Corporation of the Americas
Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 701... 2 08/14/2020 FEI # 2429304
Olympus Corporation of the Americas
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