Transmedics Inc

FDA Filings

This page includes the latest FDA filings for Transmedics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Transmedics Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3003152463
FEI Number3003152463
NameTRANSMEDICS, INC.
Owner & OperatorTransMedics
Contact Address200 Minuteman Road, Suite 302
Andover MA 01810 US
Official Correspondent
  • Thalia Charles
  • 1-978-2697900-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address200 MINUTEMAN RD STE 302
Andover, MA 01810 US
Establishment Type
  • Manufacture Device in the United States for Export Only
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
TransMedics, Inc.
Organ Care System (OCS) Heart System2021-09-03
TransMedics, Inc
Organ Care System (OCS™) Lung System2021-08-02
TransMedics, Inc.
OCS Lung Solution2021-07-29
TransMedics, Inc
Organ Care System (OCS) Lung System2020-12-03
TransMedics, Inc
Organ Care System (OCS) Lung System2019-12-20
TransMedics, Inc
Organ Care System (OCS) Lung System2019-12-20
TransMedics, Inc
Organ Care System (OCS™) Lung System2018-12-21
TRANSMEDICS, INC.
Organ Care System 14262018-07-13
TRANSMEDICS, INC.
Organ Care System 14322018-07-02
TRANSMEDICS, INC.
Organ Care System 14232018-07-02
TRANSMEDICS, INC.
Organ Care System 14042018-07-02
TRANSMEDICS, INC.
Organ Care System 14082018-07-02
TRANSMEDICS, INC.
OCS Lung System 23002018-07-02
TRANSMEDICS, INC.
OCS Lung System 24022018-07-02
TRANSMEDICS, INC.
OCS Lung System 24042018-07-02
TRANSMEDICS, INC.
OCS Lung System 24642018-07-02
TRANSMEDICS, INC.
Organ Care System 24502018-07-02
TRANSMEDICS, INC.
OCS Lung System 20002018-07-02
TRANSMEDICS, INC.
OCS Lung System 24612018-07-02
TRANSMEDICS, INC.
OCS Lung System 24612018-07-02
TRANSMEDICS, INC.
OCS Lung System 22002018-07-02
TRANSMEDICS, INC.
OCS Lung System 24012018-07-02
TRANSMEDICS, INC.
OCS Lung System 24032018-07-02
TRANSMEDICS, INC.
OCS Lung System 24602018-07-02
TRANSMEDICS, INC.
OCS Lung System 24602018-07-02
TRANSMEDICS, INC.
Organ Care System 14112018-07-02
TRANSMEDICS, INC.
Organ Care System 14082018-07-02
TransMedics, Inc
Organ Care System (OCS™) Lung System2018-06-14
TRANSMEDICS, INC. [TransMedics]
OCS Lung System2018-06-05
TRANSMEDICS, INC. [TransMedics]
OCS Lung System2018-06-05
TransMedics, Inc
Organ Care System (OCS™) Lung System2018-03-22
TRANSMEDICS, INC. [TransMedics]
TransMedics Organ Care System2013-11-07
TRANSMEDICS, INC. [TransMedics]
TransMedics Organ Care System Lung Console2013-11-07
TRANSMEDICS, INC. [TransMedics]
TransMedics Organ Care System Heart Console2013-11-07
TRANSMEDICS, INC. [TransMedics]
TransMedics Lung Solution Set2013-11-07
TRANSMEDICS, INC. [TransMedics]
TransMedics Lung Perfusion Set, including the TransMedics Lung Perfusion Module2013-11-07
TRANSMEDICS, INC. [TransMedics]
TransMedics Heart Solution Set2013-11-07
TRANSMEDICS, INC. [TransMedics]
TransMedics Heart Perfusion Set, including the TransMedics Heart Perfusion Module2013-11-07

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