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Terumo Medical Products (Hangzhou) Co., Ltd.

FDA Regulatory Profile

Terumo Medical Products (Hangzhou) Co., Ltd. appears in FDA public data with 0 recalls, 4 510(k) clearances, 4 FDA inspections, and 1 compliance action on record. Its most recent 510(k) clearance was granted on December 18, 2025.

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
4
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K252402Midline CatheterDecember 18, 2025
K252398SURFLO Hybria Closed System Safety IV CatheterDecember 17, 2025
K221411Surflo Winged Infusion SetJune 23, 2023
K220934RADIFOCUS Torque DeviceJune 29, 2022

FDA data resources