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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K083641
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Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile. 2 10/31/2023 FEI # 3012307300
Smiths Medical ASD Inc.
Bivona® TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035. 2 03/14/2017 FEI # 3012307300
Smiths Medical ASD Inc.
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