Simergent, LLC

FDA Regulatory Profile

Simergent, LLC appears in FDA public data with 0 recalls, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on October 2, 2025.

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K250523Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated PeOctober 2, 2025