FDA applicant
Bionic Instrument Corp.
FDA records 1 decision for Bionic Instrument Corp. (Walker, MI) in 1983: 1 510(k) clearance. All are in product code HXS (Twister, Wire). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bionic Instrument Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Bionic Instrument Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Bionic Instrument Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report