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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 4 of 4 Results
510(K) Number: K103582
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Product Description
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Recall
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FDA Recall
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Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small) 2 05/14/2018 Kelyniam Global, Inc.
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002 2 05/14/2018 Kelyniam Global, Inc.
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003 2 05/14/2018 Kelyniam Global, Inc.
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004 2 05/14/2018 Kelyniam Global, Inc.
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