# TransMedics, Inc.

- Location (FDA's records): Andover, MA
- FDA decisions: 6 (2018–2023): 3 510(k) clearances and 3 original PMA approvals
- Product codes: MSB (2), DTM (1), QIK (1), QQK (1), QBA (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Pall Biomedical Products Co.: 1 (https://510kreport.com/company/pall-biomedical-products)
- Bridge TO Life, Ltd.: 1 (https://510kreport.com/company/bridge-to-life)
- Vitrolife Sweden AB: 1 (https://510kreport.com/company/vitrolife-sweden)

## Recent decisions
- K231362: OCS Heart Leukocyte Depleting Filter (Oct 31, 2023)
- K222535: OCS Lung Donor Flush Set (Nov 18, 2022)
- P200031: Organ Care System (OCS™) Liver (Sep 28, 2021)
- P180051: Organ Care System (OCS) Heart System (Sep 3, 2021)
- K211314: OCS Lung Solution (Jul 29, 2021)
- P160013: Organ Care System (OCS™) Lung System (Mar 22, 2018)

Source page: https://510kreport.com/company/transmedics