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Chalice Medical , Ltd.

FDA Regulatory Profile

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K231414CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)November 1, 2023
K201642Paragon Adult Maxi PMP Oxygenator with Tubing PackSeptember 18, 2020
K191246Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)February 28, 2020