FDA applicant
Prothia USA, Inc.
FDA records 5 decisions for Prothia USA, Inc. (Mchenry, IL) from 1982 to 1983: 5 510(k) clearances. Most are in product codes BXN (Stimulator, Nerve, Battery-Powered) and GZX (Instrument, Microsurgical). 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 Prothia USA, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Prothia USA, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Prothia USA, Inc.’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