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TransMedics, Inc.

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories5
Latest FDA decision2026-05-13
TypeNumberDevice NameCodeDateActions
PMA P160013 Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantationQBA2026-05-13 View
PMA P200031 Normothermic machine perfusion system for the preservation of donor livers prior to transplantationQQK2026-05-13 View
PMA P180051 Organ care system (OCS) heart systemQIK2025-12-16 View
510(k) K231362 OCS Heart Leukocyte Depleting FilterDTM2023-10-31 View
510(k) K222535 OCS Lung Donor Flush SetMSB2022-11-18 View
510(k) K211314 OCS Lung SolutionMSB2021-07-29 View
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