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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 3 of 3 Results
510(K) Number: K083641
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Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile. 2 10/31/2023 Smiths Medical ASD Inc.
Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway ... 2 09/09/2020 Smiths Medical ASD Inc.
Bivona® TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035. 2 03/14/2017 Smiths Medical ASD Inc.