Signifier Medical Technologies

FDA Regulatory Profile

Signifier Medical Technologies appears in FDA public data with 0 recalls, 3 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent FDA inspection ended on Jul 15, 2022 (Voluntary Action Indicated (VAI)). Its most recent 510(k) clearance was granted on May 16, 2024.

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Summary

Total Recalls
0
510(k) Clearances
3
Inspections
1
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 15, 2022Wake Forest, NCDevicesVoluntary Action Indicated (VAI)3017737771

FDA Data Dashboard classifications: NAI (no action indicated), VAI (voluntary action indicated), OAI (official action indicated).

Recent 510(k) Clearances

K-NumberDeviceDate
K240328eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)May 16, 2024
K223446eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)Jan 18, 2023
DEN200018eXciteOSA with remote and eXciteOSA without remoteFeb 5, 2021