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U.S. Department of Health and Human Services

Medical Device Recalls
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21 to 30 of 44 Results
510(K) Number: K912469
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PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACH... 1 08/23/2024 Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE ... 1 08/23/2024 Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED ,... 1 08/23/2024 Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND P... 1 08/23/2024 Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUB... 1 08/23/2024 Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT T... 1 08/23/2024 Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD F... 1 08/23/2024 Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRAC... 1 08/23/2024 Smiths Medical ASD Inc.
Bivona Aire-Cuf Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 Product Usage: This tube is intended... 1 01/19/2012 Smiths Medical ASD, Inc.
Bivona Uncuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a Straight Neck Flange) Produ... 1 01/19/2012 Smiths Medical ASD, Inc.
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