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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 10 Results
510(K) Number: K042072
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Product Description
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Recall
Class
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FDA Recall
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CRANIOSCULPT FLOW, 3CC. Product Number: C-FLOW3CC, UDI: 813845020320 - - Product Usage: Callos is i... 2 07/15/2020 Skeletal Kinetics, Llc
CRANIOSCULPT FLOW, 10CC. Product Number: C-FLOW10CC, UDI: 813845020368 - - Product Usage: Callos is... 2 07/15/2020 Skeletal Kinetics, Llc
CRANIOSCULPT FLOW, CAN, 5CC. Product Number: C-FLOW5CC-CAN, UDI: 813845020344 - Product Usage: Call... 2 07/15/2020 Skeletal Kinetics, Llc
CRANIOSCULPT FLOW, OUS, 10CC. Product Number: C-FLOW10CC-OUS, UDI: 813845020382 - Product Usage: Ca... 2 07/15/2020 Skeletal Kinetics, Llc
CRANIOSCULPT FLOW, CAN, 10CC, Product Number: C-FLOW10CC-CAN, UDI: 813845020375 - Product Usage: Ca... 2 07/15/2020 Skeletal Kinetics, Llc
CRANIOSCULPT, FLOW 5CC. Product Number: C-FLOW5CC, UDI: 813845020337 - Product Usage: Callos is ind... 2 07/15/2020 Skeletal Kinetics, Llc
SKAFFOLD FLOW, 3CC and SKAFFOLD FLOW (MX) 3CC. Product Number: SKMX-FL03, UDI: 813845020887 - Produ... 2 07/15/2020 Skeletal Kinetics, Llc
SKAFFOLD FLOW (MX) 5CC. Product Number: SKMX-FL05, UDI: 813845020894 - Product Usage: Callos is ind... 2 07/15/2020 Skeletal Kinetics, Llc
SKAFFOLD FLOW, 10CC. Product Number: SKMX-FL10, UDI: 813845020900 - Product Usage: Callos is indica... 2 07/15/2020 Skeletal Kinetics, Llc
CRANIOSCULPT FLOW, OUS, 5CC Product Number: C-FLOW5CC-OUS, UDI: 813845020351 - Product Usage: Callo... 2 07/15/2020 Skeletal Kinetics, Llc
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