Medical Device Manufacturer · US , Andover , MA

TransMedics, Inc.

3 submissions · 3 cleared · Since 2021
3
Total
3
Cleared
0
Denied

TransMedics, Inc. — FDA 510(k) Submissions

TransMedics, Inc. has submitted 3 FDA 510(k) premarket notifications since 2021, of which 3 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System And Accessories, Isolated Heart, Transport And Preservation, Filter, Blood, Cardiopulmonary Bypass, Arterial Line . Use the specialty filter in the sidebar to narrow results.

3 devices
1–3 of 3
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