Covidien Manufacturing Solutions S A

FDA Filings

This page includes the latest FDA filings for Covidien Manufacturing Solutions S A. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3009211636
• FEI Number: 3009211636
• Name: Covidien Manufacturing Solutions SA
• Owner & Operator: Cardinal Health 200, LLC
• Contact Address: 3651 Birchwood Drive --; Waukegan IL 60085 US
• US Agent:
  • Christine Kuntz Nassif
  • 508 6183756
  • christine.kuntznassif@cardinalhealth.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Edificio B20 Calle #2 Zona Franca Coyol ; -- Alajuela, -- CR
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K920908 | DYB Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Argyle Peel Away Cannula Introducer	2019-06-17
PMN K040511 | JOW Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Kendall SCD Express Sequential Compression System	2018-07-27
PMN K040511 | JOW Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Kendall SCD Express Foot Cuff	2018-07-27
PMN K040511 | JOW Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Kendall SCD Controller Tubing Extension Assembly	2018-07-27
PMN K040511 | JOW Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Kendall SCD Controller Tubing Assembly	2018-07-27
PMN K951737 | FOS Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Argyle Umbilical Vessel Catheter Tray	2016-06-08
PMN K951737 | FOS Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Argyle Umbilical Vessel Catheter Insertion Tray	2016-06-08
PMN K951737 | FOS Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Argyle Umbilical Venous Catheter Tray	2016-06-08
PMN K951737 | FOS Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Argyle Polyurethane Umbilical Vessel Catheter Insertion Tray	2016-06-08
PMN K823078 | FXX Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Argyle Personal Protective Equipment	2014-11-24
DWL Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	T.E.D.? Anti-Embolism Stockings	2014-09-16
DWL Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	T.E.D.? Anti-Embolism Stockings for Continuing Care	2014-09-16
PMN K121848 | MSD Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Argyle Dialysis Catheter Accessory Introducer Needle	2014-07-07
PMN K132567 | LJS Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Argyle Peripheral Inserted Central Catheter (PICC)	2014-05-05
PMN K132567 | LJS Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Argyle Peripheral Inserted Central Catheter (PICC) Tray	2014-05-05
PMN K132567 | LJS Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Argyle Peripheral Inserted Central Catheter (PICC) Insertion Tray	2014-05-05
PMN K132567 | FOZ Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Argyle Peripheral Inserted Central Catheter (PICC)	2014-05-05
PMN K132567 | FOZ Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Argyle Peripheral Inserted Central Catheter (PICC) Tray	2014-05-05
PMN K132567 | FOZ Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Argyle Peripheral Inserted Central Catheter (PICC) Insertion Tray	2014-05-05
PMN K130725 | FOS Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Argyle Polyurethane Umbilical Vessel Catheter	2014-05-05
PMN K100306 | JOW Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Kendall SCD Sequential Compression Comfort Tear-Away Sleeves	2010-10-18
PMN K100306 | JOW Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Kendall SCD Sequential Compression Comfort Sleeves	2010-10-18
PMN K951738 | FOS Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Argyle Polyurethane Umbilical Vessel Catheter	2008-01-17
PMN K941814 | FOS Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Argyle Polyurethane Umbilical Vessel Catheter	2008-01-17
PMN K850884 | FOS Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Argyle Polyurethane Umbilical Vessel Catheter Insertion Tray	2008-01-17
PMN K843444 | DWF Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Argyle Left Ventricular Vent	2008-01-17
PMN K843444 | DWF Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Argyle Left Ventricular Sump Vent Catheter	2008-01-17
DWF Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Argyle Aortic Perfusion Cannulas	2008-01-17
PMN K822317 | DWF Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Argyle Carotid Artery Shunt Kits	2008-01-16
PMN K821445 | DWF Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Argyle Left Ventricular Catheter	2008-01-16
PMN K760966 | FOS Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Argyle PVC Umbilical Vessel Catheter	2008-01-16
PMN K942564 | FOS Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Argyle Umbilical Vessel Catheter Insertion Tray	2008-01-10
PMN K942564 | FOS Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Argyle Polyurethane Umbilical Vessel Catheter Insertion Tray	2008-01-10
PMN K781357 | JOW Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Kendall SCD Express Sleeves	2007-12-18
PMN K051805 | JOW Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Kendall SCD Express Sleeves	2007-12-18
PMN K040649 | JOW Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Kendall SCD Express Tear-Away Sleeves	2007-12-18
KGZ Covidien Manufacturing Solutions SA [Cardinal Health 200, LLC]	Devon Tube Holder	1999-08-04

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020081132387	Genova,Italy -> Houston, Texas	MAN-MADE FILAMENTS; STRIP AND THE LIKE OF MAN -MADE TEXTILE MATERIALS,SYNTHETIC FILAMENT YA RN NO SEW THREAD, NO RETAIL,TEXTUREDYARN:	560 CTN
2020080335971	Genova,Italy -> Houston, Texas	MAN-MADE FILAMENTS; STRIP AND THE LIKE OF MAN -MADE TEXTILE MATERIALS,SYNTHETIC FILAMENT YA RN NO SEW THREAD, NO RETAIL,TEXTUREDYARN:	560 CTN
2020072019028	Genova,Italy -> Houston, Texas	MAN-MADE FILAMENTS; STRIP AND THE LIKE OF MAN -MADE TEXTILE MATERIALS,SYNTHETIC FILAMENT YA RN NO SEW THREAD, NO RETAIL,TEXTUREDYARN:	560 CTN
2020071423731	Genova,Italy -> Houston, Texas	MAN-MADE FILAMENTS; STRIP AND THE LIKE OF MAN -MADE TEXTILE MATERIALS,SYNTHETIC FILAMENT YA RN NO SEW THREAD, NO RETAIL,TEXTUREDYARN:	560 CTN
2020070622395	Genova,Italy -> Houston, Texas	MAN-MADE FILAMENTS; STRIP AND THE LIKE OF MAN -MADE TEXTILE MATERIALS,SYNTHETIC FILAMENT YA RN NO SEW THREAD, NO RETAIL,TEXTUREDYARN:	560 CTN
2020062924810	Genova,Italy -> Houston, Texas	MAN-MADE FILAMENTS; STRIP AND THE LIKE OF MAN -MADE TEXTILE MATERIALS,SYNTHETIC FILAMENT YA RN NO SEW THREAD, NO RETAIL,TEXTUREDYARN:	560 CTN
2020062319845	Genova,Italy -> Houston, Texas	MAN-MADE FILAMENTS; STRIP AND THE LIKE OF MAN -MADE TEXTILE MATERIALS,SYNTHETIC FILAMENT YA RN NO SEW THREAD, NO RETAIL,TEXTUREDYARN:	560 CTN
2020051823718	Genova,Italy -> Houston, Texas	MAN-MADE FILAMENTS; STRIP AND THE LIKE OF MAN -MADE TEXTILE MATERIALS,SYNTHETIC FILAMENT YA RN NO SEW THREAD, NO RETAIL,TEXTUREDYARN:	1092 CTN
2020051823718	Genova,Italy -> Houston, Texas	MAN-MADE FILAMENTS; STRIP AND THE LIKE OF MAN -MADE TEXTILE MATERIALS,SYNTHETIC FILAMENT YA RN NO SEW THREAD, NO RETAIL,TEXTUREDYARN:	1092 CTN