Molnlycke Healthcare Us L L C

FDA Filings

This page includes the latest FDA filings for Molnlycke Healthcare Us 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 Number3004763499
FEI Number1629080
NameMOLNLYCKE HEALTHCARE, US LLC
Owner & OperatorMOLNLYCKE HEALTH CARE US LLC
Contact Address5550 Peachtree Parkway, Suite 500
Norcross GA 30092 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5550 PEACHTREE PARKWAY SUITE 500
NORCROSS, GA 30092 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI UltraTouch S Surgical Glove2019-09-25
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI UltraTouch S Indicator Underglove2019-09-25
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Normlgel2016-11-29
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Avance Foam Dressing Kit - XL2016-11-28
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Avance Y-Connector2016-11-28
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Avance ViewPad2016-11-28
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Avance Tubing2016-11-28
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Avance Foam Dressing Kits2016-11-28
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Exufiber Ag+2016-11-09
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Barrier N95 Particulate Respirator2016-08-03
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Mepiseal2016-03-30
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI Micro Indicator Underglove2015-12-21
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Mepitel Ag2015-05-14
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI Micro surgical glove2015-05-12
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Mepitel and Mepitel One2014-09-18
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Avance Transparent Film2014-09-18
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Avance Film with Safetac2014-09-18
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Transfer Ag2013-11-12
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
E-Z Derm2013-01-08
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI OrthoPro2012-02-06
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Barrier Surgical Hood2012-02-06
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Barrier Surgical Cap2012-02-06
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Barrier Nurse's Cap2012-02-06
MOLNLYCKE HEALTHCARE, US LLC
BIOGEL (R) INDICATOR (R) UNDERGLOVE2012-01-30
MOLNLYCKE HEALTHCARE, US LLC
BIOGEL ORTHOPOR BROWN SURGICAL GLOVE2011-08-24
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Border Sacrum Ag2011-07-18
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Border Post Op Ag2011-07-18
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Border Heel Ag2011-07-18
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Border Ag2011-07-18
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Ag2009-02-09
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Barrier Medical Face Mask2009-02-08
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Barrier Medical Face Mask2009-02-08
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
face Mask2009-02-08
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Barrier Medical Face Mask2009-02-08
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Tubipad2009-02-06
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Tubigrip2009-02-06
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Tubifast2009-02-06
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Setopress2009-02-06
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Dermafit2009-02-06
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI Indicator2009-01-13
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Biogel Diagnostic2008-05-07
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Biogel Super-Sensitive surgical glove2008-05-07
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Biogel Sensor Glove2008-05-07
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Biogel Indicator Underglove2008-05-07
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Biogel Opti-Fit Ortho surgical gloves2008-05-07
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Biogel Eclipse2008-05-07
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI surgical glove2008-05-07
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Biogel Surgeons Glove2008-05-07
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Biogel Skinsense2008-05-07
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI Ultratouch G surgical glove2008-05-07
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI UltraTouch surgical glove2008-05-07
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI UltraTouch M surgical glove2008-05-07
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Biogel PI Pro-Fit surgical glove2008-05-07
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Biogel Skinsense N2008-05-07
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Biogel NeoDerm2008-05-07
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Biogel M2008-04-02
MOLNLYCKE HEALTHCARE, US LLC
BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT2007-09-11
MOLNLYCKE HEALTHCARE, US LLC
BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT2007-09-11
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Mextra Superabsorbent2005-12-21
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Mepore Pro2005-12-21
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Mepilex2005-12-21
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Mepilex XT2005-12-21
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Transfer2005-12-21
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Lite2005-12-21
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Heel2005-12-21
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Border2005-12-21
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Border Sacrum2005-12-21
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Border Post Op2005-12-21
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Border Lite2005-12-21
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Border Heel2005-12-21
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Mepilex Border Flex2005-12-21
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Melgisorb Plus2005-12-21
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
MESALT2005-12-21
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
MEPORE2005-12-21
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
LYOFOAM MAX2005-12-21
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
LYOFOAM Dressings (A, C, T, Extra)2005-12-21
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Exufiber2005-12-21
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
ALLDRESS2005-12-21
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Mepore Film2005-10-06
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Mepitel Film2005-10-06
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
MEPITEL2005-10-06
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
MEPITEL ONE2005-10-06
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
MEFILM2005-10-06
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Mepiform2003-03-12
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Multiple wound dressings1996-07-24
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Mepitac1996-07-24
MOLNLYCKE HEALTHCARE, US LLC [MOLNLYCKE HEALTH CARE US LLC]
Mefix1996-07-24

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