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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K944178
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PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45 2 12/28/2020 Smiths Medical ASD Inc.
Tube Tracheostomy and Tube Cuff, Bivona® Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (mo... 2 02/23/2021 Smiths Medical ASD Inc.
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