Medtronic Navigation, Inc.-Boxborough

FDA Regulatory Profile

Medtronic Navigation, Inc.-Boxborough appears in FDA public data with 2 recalls, 0 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2451-2026, Class II) was initiated on May 19, 2026.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
6
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2451-2026Class IIMedtronic O-arm O2 Imaging System. Model Number: BI70002000.May 19, 2026
Z-2101-2025Class IIO-arm O2 Imaging System. Mobile X-Ray System.May 27, 2025