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Augment Intelligent Medical System (China) Co., Ltd.

FDA Regulatory Profile

Augment Intelligent Medical System (China) Co., Ltd. appears in FDA public data with 0 recalls, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on September 11, 2025.

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K242314Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2)September 11, 2025
K221499Minimally Invasive Prostate Surgery Navigation SystemNovember 22, 2022

FDA data resources