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U.S. Department of Health and Human Services

Medical Device Recalls
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11 to 20 of 44 Results
510(K) Number: K912469
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Bivona TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a Straight Neck Flange) Prod... 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.
Bivona Uncuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped Neck Flange) 1 01/19/2012 Smiths Medical ASD, Inc.
Bivona Uncuffed Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 (With a Straight Neck Flange) Product... 1 01/19/2012 Smiths Medical ASD, Inc.
Bivona Uncuffed Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 (With a V-Shaped Neck Flange) Produc... 1 01/19/2012 Smiths Medical ASD, Inc.
Bivona Uncuffed Pediatric Flex Tend Plus Extra Length Tracheostomy Tube Sizes 4.0 - 6.0 (With a Stra... 1 01/19/2012 Smiths Medical ASD, Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF ,... 1 08/23/2024 Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE ,... 1 08/23/2024 Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/L... 1 08/23/2024 Smiths Medical ASD Inc.
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAF... 1 08/23/2024 Smiths Medical ASD Inc.
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