510(k) Report

FDA applicant

Medtronic Midas Rex

Fort Worth, TX1 decision2002–20029 recalls

FDA records 1 decision for Medtronic Midas Rex (Fort Worth, TX) in 2002: 1 510(k) clearance. All are in product code HBB (Motor, Drill, Pneumatic). 9 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Medtronic Midas Rex’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medtronic Midas Rex since 2007.

Recalls per year

1in 2016

2008: 12009: 12015: 12016: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medtronic Midas Rex by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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