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GEMSS HEALTHCARE CO., LTD.

FDA Regulatory Profile

GEMSS HEALTHCARE CO., LTD. appears in FDA public data with 0 recalls, 2 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on November 16, 2023.

Summary

Total Recalls
0
510(k) Clearances
2
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K233200XPLUS 35 Series (XPLUS 35, XPLUS 35FD)November 16, 2023
K230800XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50November 2, 2023

FDA data resources