Oto Med Inc

FDA Regulatory Profile

Oto Med Inc appears in FDA public data with 3 recalls, 0 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1521-2021, Class II) was initiated on December 7, 2020.

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1521-2021Class IIGrace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product UsagDecember 7, 2020
Z-1520-2021Class IIGrace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: December 7, 2020
Z-1519-2021Class IIGrace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: December 7, 2020