FDA.reportPublic FDA data

MOLNLYCKE HEALTHCARE, US LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30047634991629080MOLNLYCKE HEALTHCARE, US LLC1N2020-04-255550 PEACHTREE PARKWAY SUITE 500 NORCROSS GA US 30092

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
107141627439027K984368NORMLGEL 0.9% ISOTONIC SALINE GELMGQ1999-02-22
107141565531151K971514REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVELYY1997-10-29
107141237707897K935189E-Z DERM BIOSYNTHETIC WOUND DRESSINGKGN1994-07-11
107141857828765K934194BARRIER LASER PLUS FACE MASKFXX1994-03-28
107142005612916K920108BARRIER EXTRA PROTECTION PLUS FACE MASKFXX1994-02-10
107141614064232K910557BARRIER* EXTRA PROTECTION PLUS FACE MASKFXX1991-04-29
107141079323936K190077Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator UndergloveKGO2019-05-24
107141982599597K161935Avance Foam Dressing Kit - XLOMP2016-11-04
107141130028110K161797Avance Tubing, Avance Y-Connector, Avance ViewPadOMP2016-10-19
107141792540874K160379Exufiber Ag+FRO2016-08-25
107141663454634K152741Mepiseal Soft Silicone SealantOMP2016-01-22
107141615503784K150146Biogel PI Micro Indicator UndergloveKGO2015-08-31
107141276934488K141719BIOGEL PL MICRO SURGICAL GLOVEKGO2014-09-04
107142037595761K130040MEPITEL AGFRO2014-02-12
107141539790341K123892MEPILEX TRANSFER AGFRO2013-04-05
107141314064668K122132AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAMOMP2013-01-17
107141666589220K112257BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVEKGO2011-09-20
107141772791308K102923BARRIER N95 PARTICULATE RESPIRATORMSH2010-11-19
107141802085847K100029MEPILEX BORDER AG DRESSINGFRO2010-09-15
107141084260065K081180SKINSENSE POLYISOPRENE UNDERGLOVEKGO2008-08-26
107141909315816K071700BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENTKGO2007-09-11
107141976534468K071565BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENTKGO2007-09-10
107141020620132K071465BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENTKGO2007-09-11
107141832933619K071354MEPILEX AG DRESSINGFRO2007-07-13
107141583280660K053443BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVEKGO2006-02-01
107141499195386K053442BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVEKGO2006-03-07
107141443707334K053441BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVEKGO2006-04-10
107141920169413K053102BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVEKGO2006-03-10
107141634098606K050899BIOGEL LATEX STERILE POWDER-FREE GLOVEKGO2005-08-12
107141206232251K050184BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVEKGO2005-03-16
107141597951491K000421BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVEKGO2000-08-14
107141341643336
107141400400945
107141428658944
107141693225722
107141940375439
107142043828272

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KGO152019-05-24
FRO52016-08-25
OMP42016-11-04
FXX31994-03-28
MSH12010-11-19
MGQ11999-02-22
LYY11997-10-29
KGN11994-07-11

PMN#