Soterix Medical, Inc.

FDA Regulatory Profile

Soterix Medical, Inc. appears in FDA public data with 0 recalls, 6 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on February 20, 2026.

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251653SPRY TMS Therapy System (0550)February 20, 2026
K233751Milieve (YPS-301BD)June 3, 2024
K234080MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)March 25, 2024
K192823MEGA-TMSAugust 13, 2021
K191422Neural NavigatorApril 6, 2020
K170291IontoDCMay 1, 2017