FDA.reportPublic FDA data

GETINGE AB

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30315631413031563141GETINGE AB1N2026-01-01KOPANINA 30A POZNAN Wielkopolskie PL 60-105

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3290251113576497K982063ALM PRISMALIX (PRX) SURGICAL LIGHTFSY1998-09-22
3290251407855551K970886HANAULUX BLUE 80 HOSPITALFSS1997-04-16
3290252038442267K954169HANAULUX BLUE 30 & 80FSY1996-02-01
3290251307496221K932451HANAULUX 2005 SURGICAL LIGHTFTD1993-11-12
3290251088328290K895715HANAULUX(R) 2000FTD1989-10-13
3290251502684132K214120GSS610N21 Series Steam SterilizerFLE2022-05-18
3290251190606639K201927Getinge GSS610N Series Steam SterilizerFLE2021-03-01
3290251988701246K172159Getinge GSS67N Series Steam SterilizerFLE2018-01-30
3290251535335681K153713Getinge Series Warming CabinetLHC2016-06-07
3290251442948379K130513VOLISTA 400; VOLISTA 600FTD2013-05-08
3290251866379944K122625GETINGE 800HC- SERIES STEAM STERILIZERFLE2013-05-22
3290251049254273K122071GETINGE 400HC-E / SERIES STEAM STERILIZERFLE2013-03-12
3290251171248734K120441GETINGE 700HC-E SERIES STEAM STERILIZERFLE2012-05-31
3290251948851817K113679LUCEA LED SURGICAL LIGHT SYSTEMNTN2012-01-12
3290251435792291K070657GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZERFLE2007-04-05
3290251420134894K070442POWERLED SURGICAL LIGHT SYSTEMFSY2007-03-16
3290251969967079K040735ALM X'TEN (X10) SURGICAL LIGHT SYSTEMFSY2004-05-21
3290251601764390K040015MODIFICATION TO PRISMALIX SURGICAL LIGHTFSY2004-01-21
3290251838307281K030906AXCEL SURGICAL LIGHTFSY2003-04-23
3290251001081102
3290251035567704
3290251137889184
3290251175569426
3290251225287158
3290251234416560
3290251259401780
3290251270412959
3290251317043491
3290251365280634
3290251422992849
3290251504624766
3290251551090344
3290251622987156
3290251717505178
3290251719124614
3290251757162164
3290251767414259
3290251954154348

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FLE72022-05-18
FSY62007-03-16
FTD32013-05-08
LHC12016-06-07
NTN12012-01-12
FSS11997-04-16