Molnlycke Health Care

FDA Filings

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

Molnlycke Health Care holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number8020673
FEI Number2819
NameMOLNLYCKE HEALTH CARE
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 AddressTUBITON HOUSE Medlock Street
OLDHAM Oldham, OL1 3HS GB
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Molnlycke Health Care
Otc Medication2024-12-25
Molnlycke Health Care
Otc Medication2024-12-25
Molnlycke Health Care, Xttrium Laboratories, Inc.
Otc Medication2024-12-25
Molnlycke Health Care
Otc Medication2024-06-19
Molnlycke Health Care
Otc Medication2024-06-19
Molnlycke Health Care, Xttrium Laboratories, Inc.
Otc Medication2024-06-19
Molnlycke Health Care
Otc Medication2021-12-22
Molnlycke Health Care
Otc Medication2021-12-22
Molnlycke Health Care, Xttrium Laboratories, Inc.
Otc Medication2021-12-22
Molnlycke Health Care
Otc Medication2020-12-29
Molnlycke Health Care
Otc Medication2020-12-29
Molnlycke Health Care, Xttrium Laboratories, Inc.
Otc Medication2020-12-29
Molnlycke Health Care
Otc Medication2019-12-11
Molnlycke Health Care
Otc Medication2019-12-11
Molnlycke Health Care, Xttrium Laboratories, Inc.
Otc Medication2019-12-11
Molnlycke Health Care
Otc Medication2018-12-20
Molnlycke Health Care
Otc Medication2018-12-20
Molnlycke Health Care, Xttrium Laboratories, Inc.
Otc Medication2018-12-20
MOLNLYCKE HEALTH CARE [MOLNLYCKE HEALTH CARE US LLC]
Exufiber Ag+2016-11-09
Molnlycke Health Care
Hibiclens2016-02-15
MOLNLYCKE HEALTH CARE
MEPITEL AG2014-02-12
MOLNLYCKE HEALTH CARE
MEPILEX TRANSFER AG2013-04-05
MOLNLYCKE HEALTH CARE
AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM2013-01-17
MOLNLYCKE HEALTH CARE
MEPILEX BORDER AG DRESSING2010-09-15
MOLNLYCKE HEALTH CARE [MOLNLYCKE HEALTH CARE US LLC]
Tubipad2009-02-06
MOLNLYCKE HEALTH CARE [MOLNLYCKE HEALTH CARE US LLC]
Tubigrip2009-02-06
MOLNLYCKE HEALTH CARE [MOLNLYCKE HEALTH CARE US LLC]
Tubifast2009-02-06
MOLNLYCKE HEALTH CARE [MOLNLYCKE HEALTH CARE US LLC]
Setopress2009-02-06
MOLNLYCKE HEALTH CARE [MOLNLYCKE HEALTH CARE US LLC]
Dermafit2009-02-06
MOLNLYCKE HEALTH CARE
MEPILEX AG ABSORBENT SILICONE-COATED DRESSING2007-01-25
MOLNLYCKE HEALTH CARE [MOLNLYCKE HEALTH CARE US LLC]
Mextra Superabsorbent2005-12-21
MOLNLYCKE HEALTH CARE [MOLNLYCKE HEALTH CARE US LLC]
Mepore Pro2005-12-21
MOLNLYCKE HEALTH CARE [MOLNLYCKE HEALTH CARE US LLC]
Mepilex2005-12-21
MOLNLYCKE HEALTH CARE [MOLNLYCKE HEALTH CARE US LLC]
Mepilex XT2005-12-21
MOLNLYCKE HEALTH CARE [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Transfer2005-12-21
MOLNLYCKE HEALTH CARE [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Lite2005-12-21
MOLNLYCKE HEALTH CARE [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Heel2005-12-21
MOLNLYCKE HEALTH CARE [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Border2005-12-21
MOLNLYCKE HEALTH CARE [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Border Sacrum2005-12-21
MOLNLYCKE HEALTH CARE [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Border Post Op2005-12-21
MOLNLYCKE HEALTH CARE [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Border Lite2005-12-21
MOLNLYCKE HEALTH CARE [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Border Heel2005-12-21
MOLNLYCKE HEALTH CARE [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Border Flex2005-12-21
MOLNLYCKE HEALTH CARE [MOLNLYCKE HEALTH CARE US LLC]
Melgisorb Plus2005-12-21
MOLNLYCKE HEALTH CARE [MOLNLYCKE HEALTH CARE US LLC]
MESALT2005-12-21
MOLNLYCKE HEALTH CARE [MOLNLYCKE HEALTH CARE US LLC]
MEPORE2005-12-21
MOLNLYCKE HEALTH CARE [MOLNLYCKE HEALTH CARE US LLC]
LYOFOAM MAX2005-12-21
MOLNLYCKE HEALTH CARE [MOLNLYCKE HEALTH CARE US LLC]
LYOFOAM Dressings (A, C, T, Extra)2005-12-21
MOLNLYCKE HEALTH CARE [MOLNLYCKE HEALTH CARE US LLC]
Exufiber2005-12-21
MOLNLYCKE HEALTH CARE [MOLNLYCKE HEALTH CARE US LLC]
ALLDRESS2005-12-21
MOLNLYCKE HEALTH CARE
BARRIER SURGICAL GOWNS2005-05-09

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092932972Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaMEDICAL SUPPLIES25 PKG
2020092927589Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaMEDICAL SUPPLIES27 PKG
2020092640244Bremerhaven,Federal Republic of Germany -> Boston, MassachusettsMEDICAL SUPPLIES48 PKG
202009266309Sines,Portugal -> Oakland, CaliforniaMEDICAL ITEMS14 PKG
20200926163Sines,Portugal -> Oakland, CaliforniaMEDICAL SUPPLIES25 PKG
2020092332658Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaMEDICAL SUPPLIES25 PKG
2020092327684Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaMEDICAL SUPPLIES27 PKG
2020092237010Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaMEDICAL SUPPLIES27 PKG

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