FDA applicant
Bivona Medical Technologies
FDA records 50 decisions for Bivona Medical Technologies (Gary, IN) from 1978 to 1995: 50 510(k) clearances. Most are in product codes JOH (Tube Tracheostomy And Tube Cuff) and EWL (Prosthesis, Laryngeal (Taub)). 61 recalls are linked to its devices, 28 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bivona Medical Technologies’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Bivona Medical Technologies since 2007.
Recalls per year
28in 2024
Class I Class II/III not classified
Planning a device like Bivona Medical Technologies’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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