FDA applicant
Medtrex, Inc.
FDA records 4 decisions for Medtrex, Inc. (Sandy, UT) from 1995 to 1998: 4 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Medtrex, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Medtrex, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Medtrex, 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