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/ TransMedics, Inc.
TransMedics, Inc.
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
3
Inspections
6
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K231362
OCS Heart Leukocyte Depleting Filter
October 31, 2023
K222535
OCS Lung Donor Flush Set
November 18, 2022
K211314
OCS Lung Solution
July 29, 2021