Molnlycke Health Care Oy

FDA Filings

This page includes the latest FDA filings for Molnlycke Health Care Oy. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3007605720
FEI Number3007605720
NameMolnlycke Health Care Oy
Owner & OperatorMOLNLYCKE HEALTH CARE US LLC
Contact Address5550 Peachtree Parkway, Suite 500
Norcross GA 30092 US
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressSaimaankatu 6 PO Box 76
Mikkeli Ita-Suomen laani, FI-50101 FI
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Avance Foam Dressing Kit - XL2016-11-28
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Avance Y-Connector2016-11-28
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Avance ViewPad2016-11-28
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Avance Tubing2016-11-28
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Avance Foam Dressing Kits2016-11-28
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Exufiber Ag+2016-11-09
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Mepitel Ag2015-05-14
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Mepitel and Mepitel One2014-09-18
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Avance Transparent Film2014-09-18
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Avance Film with Safetac2014-09-18
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Transfer Ag2013-11-12
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Border Sacrum Ag2011-07-18
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Border Post Op Ag2011-07-18
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Border Heel Ag2011-07-18
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Border Ag2011-07-18
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Ag2009-02-09
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Mextra Superabsorbent2005-12-21
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Mepore Pro2005-12-21
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Mepilex2005-12-21
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Mepilex XT2005-12-21
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Transfer2005-12-21
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Lite2005-12-21
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Heel2005-12-21
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Border2005-12-21
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Border Sacrum2005-12-21
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Border Post Op2005-12-21
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Border Lite2005-12-21
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Border Heel2005-12-21
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Border Flex2005-12-21
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Melgisorb Plus2005-12-21
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
MESALT2005-12-21
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
MEPORE2005-12-21
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
LYOFOAM MAX2005-12-21
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
LYOFOAM Dressings (A, C, T, Extra)2005-12-21
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Exufiber2005-12-21
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
ALLDRESS2005-12-21
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Mepore Film2005-10-06
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Mepitel Film2005-10-06
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
MEPITEL2005-10-06
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
MEPITEL ONE2005-10-06
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
MEFILM2005-10-06
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Mepiform2003-03-12
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Multiple wound dressings1996-07-24
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Mepitac1996-07-24
Molnlycke Health Care Oy [MOLNLYCKE HEALTH CARE US LLC]
Mefix1996-07-24

Related Finance Registrations
NCAGE CodeS5852MOLNLYCKE HEALTH CARE OY
NCAGE CodeA148GMOLNLYCKE HEALTH CARE OY
NCAGE CodeA045GMOLNLYCKE HEALTH CARE OY
CAGE CodeA045GMOLNLYCKE HEALTH CARE OY
CAGE CodeA148GMOLNLYCKE HEALTH CARE OY
CAGE CodeS5852MOLNLYCKE HEALTH CARE OY
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2018073018693Stadersand,Federal Republic of Germany -> Oakland, CaliforniaWOUND CARE PRODUCTS DELIVERIES 861155913, 86115648 HS CODE 3005100015 PCS
2018073034014Bremerhaven,Federal Republic of Germany -> New York, New YorkWOUND CARE PRODUCTS HOSPITAL PRODUCTS & RAW MATERIALS DELIVERIES 861157992, 86115799 HS CODE 5603121046 PCS
2018072848231Reykjavik,Iceland -> Portland, MaineHOSPITAL PRODUCTS53 PKG
2018072517578Stadersand,Federal Republic of Germany -> Oakland, CaliforniaWOUND CARE PRODUCTS DELIVERIES 861135116, 86113512 HS CODE 3005100016 PCS
2018072059633Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaWOUND CARE PRODUCTS DELIVERIES 861139962, 86114601,86114878 HS CODE 3005100025 PCS
2018072059627Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaWOUND CARE PRODUCTS DELIVERIES 861167732, 86117182 HS CODE 3005100026 PCS
2018072059629Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaWOUND CARE PRODUCTS DELIVERIES 861160772 HS CODE 3005100025 PCS
2018072059631Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaWOUND CARE PRODUCTS DELIVERIES 861154797 HS CODE 3005100025 PCS
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