Mallinckrodt Hospital Products Ip L T D

FDA Filings

This page includes the latest FDA filings for Mallinckrodt Hospital Products Ip 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 Number: 3009352626
• FEI Number: 2350054
• Name: Mallinckrodt Manufacturing LLC
• Owner & Operator: Mallinckrodt Hospital Products IP Limited
• Contact Address: Damastown Industrial Estate ; Mulhuddart IE-D Dublin 15 IE
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1060 Allendale Dr ; Port Allen, LA 70767 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3004531588
• FEI Number: 3004531588
• Name: Mallinckrodt Manufacturing LLC
• Owner & Operator: Mallinckrodt Hospital Products IP Limited
• Contact Address: Damastown Industrial Estate ; Mulhuddart IE-D Dublin 15 IE
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 6603 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	Device	Date
PMN K843640 | IYT Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	Xenotron I Xenon (Xe 133) Gas Dispenser	2016-07-18
BYX Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	Xenotron - Stopcock/Interconnect Accessory	2016-07-18
PMN K092545 | MRQ Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOMAX DS DELIVERY SYSTEM	2016-07-06
PMN K092545 | MRP Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOMAX DS DELIVERY SYSTEM	2016-07-06
PMN K092545 | MRO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOMAX DS DELIVERY SYSTEM	2016-07-06
PMN K092545 | MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOMAX DS DELIVERY SYSTEM	2016-07-06
PMN K143213 | MRQ Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR Plus MRI (Delivery System)	2016-06-30
PMN K143213 | MRP Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR Plus MRI (Delivery System)	2016-06-30
PMN K143213 | MRO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR Plus MRI (Delivery System)	2016-06-30
PMN K143213 | MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR Plus MRI (Delivery System)	2016-06-30
PMN K131686 | MRQ Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR (Delivery System)	2016-06-30
PMN K131686 | MRP Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR (Delivery System)	2016-06-30
PMN K131686 | MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR (Delivery System)	2016-06-30
PMN K130605 | MRQ Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR (Delivery System)	2016-06-30
PMN K130605 | MRP Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR (Delivery System)	2016-06-30
PMN K130605 | MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR (Delivery System)	2016-06-30
PMN K122689 | MRO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOblender	2016-06-30
PMN K121021 | MRQ Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR (Delivery System)	2016-06-30
PMN K121021 | MRP Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR (Delivery System)	2016-06-30
PMN K121021 | MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR (Delivery System)	2016-06-30
PMN K113272 | MRP Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR (Delivery System)	2016-06-30
PMN K113272 | MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR (Delivery System)	2016-06-30
PMN K113272 | MPQ Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR (Delivery System)	2016-06-30
PMN K110635 | MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR (Delivery System)	2016-06-30
PMN K110344 | MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DSIR (Delivery System)	2016-06-30
PMN K093922 | MRQ Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K093922 | MRP Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K093922 | MRO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K093922 | MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K090958 | MNR Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K081691 | MRQ Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K081691 | MRP Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K081691 | MRO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K081691 | MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K080484 | MRQ Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K080484 | MRP Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K080484 | MRO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K080484 | MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K071516 | MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K070867 | MRQ Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K070867 | MRP Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K070867 | MRO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
PMN K070867 | MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOmax DS (Delivery System)	2016-06-30
BZO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	Adapter , Gas Sample Tee	2016-05-23
BZO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	Adapter , Cuff, 22 mm ID X 22 mm ID	2016-05-23
BZO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	Adapter , 22M/15F X 22M/15F	2016-05-23
BZO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	Adapter , 22F X 15M	2016-05-23
BZO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	Adapter , 22 mm OD X 10 mm OD	2016-05-23
BZO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	15M Adapter (fits 8.0 mm ID Tubing)	2016-05-23
BZO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	15 M Adapter (fits 4.5 mm ID Tubing)	2016-05-23
PMN K061901 | MRQ Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOMAX DS DELIVERY SYSTEM	2015-12-17
PMN K061901 | MRP Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOMAX DS DELIVERY SYSTEM	2015-12-17
PMN K061901 | MRO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOMAX DS DELIVERY SYSTEM	2015-12-17
PMN K061901 | MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOMAX DS DELIVERY SYSTEM	2015-12-17
PMN K052663 | MRO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOBLENDER	2015-12-17
PMN K000186 | MRQ Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOvent	2015-12-17
PMN K000186 | MRP Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOvent	2015-12-17
PMN K000186 | MRO Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOvent	2015-12-17
PMN K000186 | MRN Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOvent	2015-12-17
BXK Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOcal Nitrogen Dioxide Calibration Gas	2015-12-17
BXK Mallinckrodt Manufacturing LLC [Mallinckrodt Hospital Products IP Limited]	INOcal Nitric Oxide Calibration Gas	2015-12-17