Mallinckrodt Manufacturing L L C

FDA Filings

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

FDA Registration(s)
Registration Number3009352626
FEI Number2350054
NameMallinckrodt Manufacturing LLC
Owner & OperatorMallinckrodt Hospital Products IP Limited
Contact AddressDamastown Industrial Estate
Mulhuddart IE-D Dublin 15 IE
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1060 Allendale Dr
Port Allen, LA 70767 US
Establishment TypeManufacture Medical Device



Registration Number3004531588
FEI Number3004531588
NameMallinckrodt Manufacturing LLC
Owner & OperatorMallinckrodt Hospital Products IP Limited
Contact AddressDamastown Industrial Estate
Mulhuddart IE-D Dublin 15 IE
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address6603 Femrite Dr
MADISON, WI 53718 US
Establishment Type
  • Remanufacture Medical Device
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
Mallinckrodt Manufacturing LLC
INOmax DSIR Plus2020-06-17
INO Therapeutics, Mallinckrodt Manufacturing LLC
Prescription Medication2019-02-26
Mallinckrodt Manufacturing LLC
INOblender MRI 2018-07-06
Mallinckrodt Manufacturing LLC
INOblender 2018-07-06
Mallinckrodt Manufacturing LLC
INOmax DSIR Plus MRI 2018-07-06
Mallinckrodt Manufacturing LLC
INOmax DSIR Plus 2018-07-06
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
Xenotron I Xenon (Xe 133) Gas Dispenser2016-07-18
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
Xenotron - Stopcock/Interconnect Accessory2016-07-18
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOMAX DS DELIVERY SYSTEM2016-07-06
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOMAX DS DELIVERY SYSTEM2016-07-06
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOMAX DS DELIVERY SYSTEM2016-07-06
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOMAX DS DELIVERY SYSTEM2016-07-06
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DSIR Plus MRI (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DSIR Plus MRI (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DSIR Plus MRI (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DSIR Plus MRI (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DSIR (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DSIR (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DSIR (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DSIR (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DSIR (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DSIR (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOblender2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DSIR (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DSIR (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DSIR (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DSIR (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DSIR (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DSIR (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DSIR (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DSIR (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DS (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DS (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DS (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DS (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DS (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DS (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DS (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DS (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DS (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DS (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DS (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DS (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DS (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DS (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DS (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DS (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DS (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOmax DS (Delivery System)2016-06-30
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
Adapter , Gas Sample Tee2016-05-23
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
Adapter , Cuff, 22 mm ID X 22 mm ID2016-05-23
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
Adapter , 22M/15F X 22M/15F2016-05-23
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
Adapter , 22F X 15M2016-05-23
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
Adapter , 22 mm OD X 10 mm OD2016-05-23
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
15M Adapter (fits 8.0 mm ID Tubing)2016-05-23
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
15 M Adapter (fits 4.5 mm ID Tubing)2016-05-23
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOMAX DS DELIVERY SYSTEM2015-12-17
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOMAX DS DELIVERY SYSTEM2015-12-17
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOMAX DS DELIVERY SYSTEM2015-12-17
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOMAX DS DELIVERY SYSTEM2015-12-17
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOBLENDER2015-12-17
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOvent2015-12-17
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOvent2015-12-17
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOvent2015-12-17
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOvent2015-12-17
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOcal Nitrogen Dioxide Calibration Gas2015-12-17
Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]
INOcal Nitric Oxide Calibration Gas2015-12-17

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