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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 5 of 5 Results
510(K) Number: K922665
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Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0mm length ... 2 01/18/2006 Smiths Medical ASD, Inc.
Bivona brand Mid-Range Aire-Cuf Extra Length Fixed Hyperflex Adult Tracheostomy Tube, I.D. 8.0 mm O... 2 01/18/2006 Smiths Medical ASD, Inc.
Bivona brand Mid-Range Aire-Cuf Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 6.0 mm O.D.... 2 01/18/2006 Smiths Medical ASD, Inc.
Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product... 3 01/06/2006 Smiths Medical ASD, Inc.
Bivona brand Adjustable Hyperflex Tracheostomy Tube, Pediatric, cuffless; catalog # 60HA40. 2 06/12/2003 Portex, Inc
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