Mallinckrodt Pharmaceuticals Ireland L T D

FDA Filings

This page includes the latest FDA filings for Mallinckrodt Pharmaceuticals Ireland L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3013428851
FEI Number3013428851
NameMALLINCKRODT PHARMACEUTICALS IRELAND LTD
Owner & OperatorMallinckrodt Pharmaceuticals Ireland Ltd
Contact AddressCollege Business & Technology Park Cruiserath Road
Blanchardstown IE-D Dublin D15 TX2V IE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressCollege Business & Technology Park Cruiserath Road
Blanchardstown Dublin, D15 TX2V IE
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERA2021-10-01
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA/CLXECP),THERAKOS CEL2021-10-01
Mallinckrodt Pharmaceuticals Ireland Limited
Therakos CELLEX Photopheresis System2020-07-31
Mallinckrodt Pharmaceuticals Ireland Limited
Therakos CELLEX Procedural Kit2019-05-13
Mallinckrodt Pharmaceuticals Ireland Limited
Therakos CELLEX Procedural Kit2019-01-10
Mallinckrodt Pharmaceuticals Ireland Limited
Therakos CELLEX Procedural Kit2018-11-01
MALLINCKRODT PHARMACEUTICALS IRELAND LTD
Therakos CELLEX Photopheresis System; UVAR XTS Photopheresis System2018-03-28
Mallinckrodt Pharmaceuticals Ireland Limited
Therakos Cellex Procedural Kit2018-03-08
Mallinckrodt Pharmaceuticals Ireland Limited
Therakos Cellex Photopheresis System2018-01-28
Mallinckrodt Pharmaceuticals Ireland Limited
Therakos Cellex Photopheresis System2018-01-26
Mallinckrodt Pharmaceuticals Ireland Limited
Therakos Cellex Procedural Kit2017-10-06
Mallinckrodt Pharmaceuticals Ireland Limited
CELLEX PHOTOPHERESIS SYSTEM2017-09-14
Mallinckrodt Pharmaceuticals Ireland Limited
Therakos CELLEX Procedural Kit2017-08-18
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEX Photopheresis Procedural Kit2017-08-17
Mallinckrodt Pharmaceuticals Ireland Limited
Therakos CELLEX Photopheresis System2017-07-21
Mallinckrodt Pharmaceuticals Ireland Limited
Therakos Uvar XTS Photopheresis System Procedural Kit.2017-05-16
Mallinckrodt Pharmaceuticals Ireland Limited
Therakos CELLEX and UVAR XTS Procedural Kits2017-05-02
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEX PHOTOPHERESIS SYSTEM, INSTRUMENT, LIGHT ASSEMBLY, PROCEDURAL KIT.2017-04-27
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS UVAR XTS Photopheresis System Procedural Kit2016-05-05
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR PHOTOPHERESIS SYSTEM2016-04-22
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT2016-04-08
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEX PROCEDURAL KIT2016-02-25
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT2016-01-21
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEX PHOTOSPHERESIS SYSTEM INSTRUMENT2015-11-02
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEX PROCEDURAL KIT2015-07-30
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM2015-04-16
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEXPHOTOPHERESIS SYSTEM2015-03-19
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM2015-02-03
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS UVAR XTS AND THERAKOS CELLEX PHOTOPHERESIS SYSTEM2014-08-21
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEX PHOTOPHERESIS KIT2014-05-09
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEX INSTRUMENT,PHOTOPHERESIS PROCEDURAL KIT,AND LIGHT ASSEMBLY2013-08-28
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEX/UVAR XTS PHOTOPHERESIS SYSTEM2013-08-08
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEX INSTRUMENT, THERAKOS CELLEX PHOTOPHERESIS PROCEDURAL KIT (125ML) THERAKOS CELLEX LIGHT ASSEMBLY2013-05-06
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEX PHOTOPHRESES SYSTEM2013-05-01
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT2013-03-20
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEX PHOTOPHERESIS SYSTEM2013-02-19
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEX / THERAKOS UVAR XTS PHOTOPHERESIS SYSTEMS2013-02-15
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEX INSTRUMENT, THERAKOS CELLEX PHOTOPHRESSIS PROCEDURAL KIT (125 ML), CLX, THERAKOS CELLEX LIGHT ASSEMBLY ,2012-11-19
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS UVAR XTS INSTRUMENT, THERAKOS UVAR XTS PROCEDURAL KIT (125 ML), THERAKOS UVAR XTS PORCEDURAL KIT (225 ML), THEA2012-11-09
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEX / PHOTOPHERESIS SYSTEMS2012-04-04
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM2012-03-02
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEX PHOTOPHERESIS SYSTEM2012-01-10
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEX PHOTOPHERESIS SYSTEMS2011-10-28
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEX PHOTOPHERESIS SYSTEM2011-09-22
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEX PHOTOPHERESIS SYSTEM2011-08-05
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEX PHOTOPHERESIS SYSTEM2011-07-29
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT2011-05-13
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEX PHOTOPHERESIS SYSTEM2011-04-21
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR XTS PROCEDURAL KIT2011-01-25
Mallinckrodt Pharmaceuticals Ireland Limited
CELLEX PROCEDURAL KIT2010-12-09
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEX PHOTOPHERESIS SYSTEM2009-09-15
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS CELLEX* PHOTOPHERESIS SYSTEM2009-05-27
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR CELLEX PHOTOPHERESIS SYSTEM2009-03-20
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR XTS PHOTOPHERESIS SYSTEM2009-01-16
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR XTS PHOTOPHERESIS SYSTEM2008-12-19
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM2008-08-29
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR XTS PHOTOPHERESIS SYSTEM2008-02-01
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR XTS PHOTOPHERESIS SYSTEM2006-12-22
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR XTS PHOTOPHERESIS SYSTEM2006-07-14
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR XTS PHOTOPHERESIS SYSTEM2005-08-19
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR XTS PHOTOPHERESIS SYSTEM2002-12-20
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR XTS PHOTOPHERESIS SYSTEM2002-11-25
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR XTS PHOTOPHERESIS SYSTEM2002-04-12
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR(R) XTS(TM) PHOTOPHERESIS SYSTEM2001-05-22
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR(R) XTS(R) PHOTOPHERESIS SYSTEM2001-02-15
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR XTS(TM) PHOTOPHERESIS SYSTEM2001-01-05
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR PHOTOPHERESIS SYSTEM2000-11-22
Mallinckrodt Pharmaceuticals Ireland Limited
UVADEX(R) STERILE LIQUID2000-03-06
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR XTS PHOTOPHORESIS SYSTEM2000-01-14
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR XTS PHOTOPHERESIS SYSTEM1999-11-29
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR PHOTOPHORESIS SYSTEM1999-09-07
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR XTS PHOTOPHERESIS SYSTEM1999-08-10
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR XTS PHOTOPHERESIS SYSTEM1998-09-01
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR PHOTOPHORESIS SYSTEM1998-02-26
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR PHOTOPHORESIS SYSTEM1997-03-25
Mallinckrodt Pharmaceuticals Ireland Limited
THERAKOS UVAR(R) PHOTOPHORESIS SYSTEM1996-10-03
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR PHOTOPHORESIS SYSTEM1996-05-17
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR PHOTOPHORESIS SYSTEM1995-05-18
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR PHOTOPHORESIS SYSTEM1995-01-26
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR PHOTOPHERESIS SYSTEM1993-12-07
Mallinckrodt Pharmaceuticals Ireland Limited
TPS 101 PHOTOPHERESIS BLOOD TUBING SET1992-06-19
Mallinckrodt Pharmaceuticals Ireland Limited
TPS 102 PHOTOCEPTOR ACTIVATION CHAMBER1992-06-19
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR PHOTOPHERESIS SYSTEM (TSP-101) BLOOD TUBING1991-03-11
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR PHOTOPHERESIS SYSTEM (TSP-101) BLOOD TUBING1991-02-13
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR PHOTOPHERESIS SYSTEM1990-12-13
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR PHOTOPHERESIS SYSTEM1990-02-23
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR PHOTOPHERESIS SYSTEM1990-01-26
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR PHOTOPHERESIS SYSTEM1989-12-22
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR PHOTOPHERESIS SYSTEM1989-04-12
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR PHOTOPHERESIS SYSTEM1988-12-29
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR PHOTOPHERESIS SYSTEM1988-12-28
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR PHOTOPHERESIS SYSTEM1988-10-07
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR PHOTOPHERESIS SYSTEM1988-06-30
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR PHOTOPHERESIS SYSTEM1988-06-17
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR PHOTOPHERESIS SYSTEM1988-02-10
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR PHOTOPHERESIS SYSTEM1987-11-06
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR PHOTOPHERESIS SYSTEM1987-11-06
Mallinckrodt Pharmaceuticals Ireland Limited
UVAR PHOTOPHERESIS SYSTEM1987-09-09

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