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:

• GONOTEC GESELLSCHAFT FUER MESS-UND REGELTECHNIK MBH

FDA Registration(s)

• Registration Number: 3003152463
• FEI Number: 3003152463
• Name: TRANSMEDICS, INC.
• Owner & Operator: TransMedics
• Contact Address: 200 Minuteman Road, Suite 302 ; Andover MA 01810 US
• Official Correspondent:
  • Thalia Charles
  • 1-978-2697900-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 200 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	Device	Date
GUDID B00958755 TRANSMEDICS, INC.	OCS Lung Donor Flush Set 2406	2023-06-21
PMN K222535 TransMedics, Inc.	OCS Lung Donor Flush Set	2022-11-18
GUDID B00953975 TRANSMEDICS, INC.	Organ Care System 1404	2021-12-09
GUDID B00950491 TRANSMEDICS, INC.	OCS Liver System 3000	2021-12-09
GUDID B00950443 TRANSMEDICS, INC.	OCS Liver System 3450	2021-12-09
GUDID B00949381 TRANSMEDICS, INC.	OCS Liver System 3440	2021-12-09
GUDID B00949290 TRANSMEDICS, INC.	OCS Heart System 1000	2021-12-09
GUDID B00948913 TRANSMEDICS, INC.	OCS Heart System 1457	2021-12-09
GUDID B00948895 TRANSMEDICS, INC.	OCS Liver System 3457	2021-12-09
GUDID B00948225 TRANSMEDICS, INC.	OCS Heart System 1200	2021-12-09
GUDID B00946653 TRANSMEDICS, INC.	OCS Liver System 3406	2021-12-09
GUDID B00946643 TRANSMEDICS, INC.	OCS Liver System 3406	2021-12-09
GUDID B00944915 TRANSMEDICS, INC.	OCS Liver System 3421	2021-12-09
GUDID B00944905 TRANSMEDICS, INC.	OCS Liver System 3401	2021-12-09
GUDID B00944895 TRANSMEDICS, INC.	OCS Liver System 3400	2021-12-09
GUDID B00944707 TRANSMEDICS, INC.	OCS Liver System 3200	2021-12-09
GUDID B00943661 TRANSMEDICS, INC.	OCS Heart System 1461	2021-12-09
GUDID B00936463 TRANSMEDICS, INC.	OCS Heart System 1421	2021-12-09
GUDID B00936363 TRANSMEDICS, INC.	OCS Heart System 1401	2021-12-09
GUDID B00926340 TRANSMEDICS, INC.	OCS Heart System 1300	2021-12-09
GUDID B00925751 TRANSMEDICS, INC.	OCS Heart System 1427	2021-12-09
GUDID B00925741 TRANSMEDICS, INC.	OCS Heart System 1425	2021-12-09
GUDID B00925721 TRANSMEDICS, INC.	OCS Heart System 1424	2021-12-09
GUDID B00924420 TRANSMEDICS, INC.	OCS Heart System 1406	2021-12-09
GUDID B00918043 TRANSMEDICS, INC.	OCS Heart System 1400	2021-12-09
GUDID B00913600 TRANSMEDICS, INC.	OCS Heart System 1406	2021-12-09
GUDID B00913390 TRANSMEDICS, INC.	OCS Heart System 1410	2021-12-09
PMA P200031 TransMedics, Inc.	Organ Care System (OCS™) Liver	2021-09-28
PMA P180051 TransMedics, Inc.	Organ Care System (OCS) Heart System	2021-09-03
PMA P160013S008 TransMedics, Inc	Organ Care System (OCS™) Lung System	2021-08-02
PMN K211314 TransMedics, Inc.	OCS Lung Solution	2021-07-29
PMA P160013S007 TransMedics, Inc	Organ Care System (OCS) Lung System	2020-12-03
PMA P160013S006 TransMedics, Inc	Organ Care System (OCS) Lung System	2019-12-20
PMA P160013S005 TransMedics, Inc	Organ Care System (OCS) Lung System	2019-12-20
PMA P160013S003 TransMedics, Inc	Organ Care System (OCS™) Lung System	2018-12-21
GUDID B00925733 TRANSMEDICS, INC.	Organ Care System 1426	2018-07-13
GUDID B00954033 TRANSMEDICS, INC.	Organ Care System 1432	2018-07-02
GUDID B00954003 TRANSMEDICS, INC.	Organ Care System 1423	2018-07-02
GUDID B00953985 TRANSMEDICS, INC.	Organ Care System 1404	2018-07-02
GUDID B00950841 TRANSMEDICS, INC.	Organ Care System 1408	2018-07-02
GUDID B00944671 TRANSMEDICS, INC.	OCS Lung System 2300	2018-07-02
GUDID B00943281 TRANSMEDICS, INC.	OCS Lung System 2402	2018-07-02
GUDID B00940013 TRANSMEDICS, INC.	OCS Lung System 2404	2018-07-02
GUDID B00939313 TRANSMEDICS, INC.	OCS Lung System 2464	2018-07-02
GUDID B00939301 TRANSMEDICS, INC.	Organ Care System 2450	2018-07-02
GUDID B00939231 TRANSMEDICS, INC.	OCS Lung System 2000	2018-07-02
GUDID B00939183 TRANSMEDICS, INC.	OCS Lung System 2461	2018-07-02
GUDID B00939173 TRANSMEDICS, INC.	OCS Lung System 2461	2018-07-02
GUDID B00938535 TRANSMEDICS, INC.	OCS Lung System 2200	2018-07-02
GUDID B00937673 TRANSMEDICS, INC.	OCS Lung System 2401	2018-07-02
GUDID B00937663 TRANSMEDICS, INC.	OCS Lung System 2403	2018-07-02
GUDID B00928603 TRANSMEDICS, INC.	OCS Lung System 2460	2018-07-02
GUDID B00928593 TRANSMEDICS, INC.	OCS Lung System 2460	2018-07-02
GUDID B00925711 TRANSMEDICS, INC.	Organ Care System 1411	2018-07-02
GUDID B00912501 TRANSMEDICS, INC.	Organ Care System 1408	2018-07-02
PMA P160013S001 TransMedics, Inc	Organ Care System (OCS™) Lung System	2018-06-14
PMN P160013 | QBA TRANSMEDICS, INC. [TransMedics]	OCS Lung System	2018-06-05
PMN P160013 | PHO TRANSMEDICS, INC. [TransMedics]	OCS Lung System	2018-06-05
PMA P160013 TransMedics, Inc	Organ Care System (OCS™) Lung System	2018-03-22
MSB TRANSMEDICS, INC. [TransMedics]	TransMedics Organ Care System	2013-11-07
MSB TRANSMEDICS, INC. [TransMedics]	TransMedics Organ Care System Lung Console	2013-11-07
MSB TRANSMEDICS, INC. [TransMedics]	TransMedics Organ Care System Heart Console	2013-11-07
MSB TRANSMEDICS, INC. [TransMedics]	TransMedics Lung Solution Set	2013-11-07
MSB TRANSMEDICS, INC. [TransMedics]	TransMedics Lung Perfusion Set, including the TransMedics Lung Perfusion Module	2013-11-07
MSB TRANSMEDICS, INC. [TransMedics]	TransMedics Heart Solution Set	2013-11-07
MSB TRANSMEDICS, INC. [TransMedics]	TransMedics Heart Perfusion Set, including the TransMedics Heart Perfusion Module	2013-11-07

Similar & Related FDA Registered Companies

• TransMedics, Inc.200 Minuteman Roadsuite 302andover, MA 01810 PMA NumberP200031 Supplement NumberS001 Date Received04/08/2022 Decision Date09/19/2022 Product Code QQK  Advisory Committee Gastroenterology/Urology Clinical TrialsNCT02522871 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No
• TransMedics, Inc200 Minuteman Roadsuite 302andover, MA 01810 PMA NumberP160013 Supplement NumberS009 Date Received02/07/2022 Decision Date05/06/2022 Product Codes PHO QBA  Advisory Committee Gastroenterology/Urology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• TransMedics, Inc.200 Minuteman Road, Suite 302andover, MA 01810 PMA NumberP180051 Supplement NumberS001 Date Received11/08/2021 Decision Date04/27/2022 Product Code QIK  Advisory Committee Cardiovascular Clinical TrialsNCT03831048 Supplement Typepanel Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No

Related Finance Registrations

SEC

0001092287

TransMedics, Inc. of DELAWARE