FDA.reportPublic FDA data

Applied Medical Europe

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30097630193009763019Applied Medical Europe1N2026-01-01Wiekenweg 21 Amersfoort Utrecht NL 3815 KL

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1787481111636336K993650URETERAL ACCESS SHEATH SET - NEW MODELSFED1999-12-28
1787481506564538K993135IMPLANTABLE CLIP FOR GENERAL SURGERYFZP1999-12-01
1787481542190659K991219C-FLEX URETERAL STENTSFAD1999-06-21
1787481527678944K980987BECTON DICKINSON SYRINGEFMF1998-06-11
1787481377322711K963359INSUFFLATION NEEDLEHET1996-09-24
1787481833204696K962668AMR-ACV CLAMPSDXC1996-11-04
1787481638455619K950492ATRAUMAX SURGICAL CLAMPDXC1995-05-08
1787481977121392K945591APPLIED MEDICAL OPTICAL VALVULOTOMELYK1995-02-10
1787481077592249K944135UROLOGICAL GUIDWIREKNY1994-09-21
1787481505856789K943489DISPOSABLE SURGICAL TROCARGCJ1994-08-09
1787481140768919K941012LOW PRESSURE TAMPONADE BALLOON CATHETEREYB1994-04-18
1787481140621589K932995SURGICAL TROCAR AND CANNULAGCJ1993-09-23
1787481144427289K931895ENDOSCOPE ACCESSORYGCJ1993-09-07
1787481650560157K923636TROCAR W/ BLUNT TIP OBTURATORHET1993-11-05
1787481372061309K921838ACUCISE URETERAL CUTTING CATHETEREYB1993-02-26
1787481406317621K920030SURESEAL ENDOSCOPIC VALVEODC1992-03-18
1787481430148382K905738OPERATIVE CHOLANGIOGRAPHIC CATHETERFGE1991-03-21
1787481104296000K903848DIAGNOSTIC INTRASCULAR CATHETERDQO1991-03-25
1787481395379831K901628APPLIED VASCULAR DEVICES 6MM TRACTION CLIPDXC1990-07-06
1787481974658392K901565ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDEDXC1990-06-12
1787482027106207K895691VASCULAR CLAMPDXC1989-12-13
1787481625189987K891296ATRAUMAX(TM) SURGICAL CLAMPSDXC1989-06-07
1787481402810198K883909SURGICAL SPRING CLIPSDSS1988-12-27
1787481109723200K883790SURGICAL CLAMP INSERTSDXC1988-12-27
1787481291448936K880987INJECTOR HANDLE WITH SYRINGEDXT1988-05-13
1787482031022648K211043Alexis Contained Extraction SystemGCJ2022-03-31
1787481000114303K191294Transvaginal Access PlatformHEW2019-09-06
1787481746619779K190331Applied Medical Laparoscopic Linear CutterGDW2019-11-22
1787481596740812K182653Voyant Maryland Fusion DeviceGEI2018-11-14
1787481948034507K182244Voyant Electrosurgical GeneratorGEI2018-10-11
1787481875879990K180699Voyant Open Fusion DeviceGEI2018-04-13
1787481496533614K172624Voyant 5mm Fusion DeviceGEI2018-02-13
1787481020755010K171701GelPOINT Path Transanal Access PlatformFER2017-07-20
1787481809521213K171684Epix Electrosurgical Probe with Smoke EvacuationGEI2017-08-07
1787481906981758K162676Voyant Open Fusion DeviceGEI2016-12-01
1787481322528095K153017Voyant Fine FusionGEI2016-07-06
1787481422829029K151480Epix Electrosurgical Probe with Smoke EvacuationGEI2016-02-19
1787481339799956K143308GelPOINT Transvaginal Access PlatformHEW2015-10-13
1787482043297367K142427TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25GCJ2014-12-23
1787481695938854K141288VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICEGEI2014-08-22
1787481447531040K133393GELPOINT PATH TRANSANAL ACCESS PLATFORMFER2014-01-02
1787481073281940K132300EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, REGEI2014-01-24
1787481340184936K122619EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SETBTA2012-10-02
1787481080976531K113268ALEXIS O WOUND PROTECTOR/RETRACTORKGW2013-02-08
1787481026734310K110792GELPOINT PATHFER2011-05-23
1787481184345470K103282LAPAROSCOPIC DISSECTORGEI2010-11-16
1787481040792889K100959SPECIMEN RETRIEVAL SYSTEMGCJ2010-04-22
1787482068660443K100120ALEXIS ORTHOPAEDIC WOUND RETRACTORKGW2010-04-02
1787481562737732K093296ALEXIS LAPAROSCOPIC SYSTEMKGW2009-11-05
1787481894847465K090275GELPORT SINGLE INCISION ACCESS SYSTEMGCJ2009-02-18
1787481721005382K083638FIXATION TROCARSGCJ2008-12-23
1787482060383859K072674KII TROCAR SYSTEMGCJ2007-10-05
1787481404249633K062907ALEXIS WOUND RETRACTORKGW2007-01-09
1787481867361539K062169APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORSHET2006-08-24
1787481984965532K060673PEDIATRIC URETERAL STENTFAD2006-03-29
1787481777340991K060629GELPORT BLUNT TIP TROCAR SYSTEMGCJ2006-04-07
1787481544758685K060534INTUITIVE SURGICAL SEALGCJ2006-03-13
1787481560083087K060096MODULAR TROCAR SYSTEMGCJ2006-01-24
1787482014348544K060051SPECIMEN RETRIEVAL SYSTEMGCJ2006-01-19
1787481426983339K041795MODIFICATION TO OPTICAL SEPARATOR SYSTEMGCJ2004-09-14
1787481388913102K041711ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304KGW2004-08-26
1787481649681558K040760MODIFICATION TO URETERAL STENTFAD2004-10-15
1787481057625121K040295APPLIED LAPAROSCOPIC MONOPOLAR SCISSORSHET2004-03-12
1787481811282318K032889OPTICAL SEPARATORGCJ2003-10-02
1787481053799340K030642DEFLECTING URETERAL ACCESS SHEATHFED2003-05-23
1787481927675236K014047APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICEGCJ2002-02-28
1787481582555126K011236MODIFICATION TO IMPLANTABLE CLIPFZP2001-05-14
1787481692084712K003443SUCTION IRRIGATORFHF2001-02-01
1787481770073585K002915FLEXIBLE OCCLUSION SYSTEMDXC2001-01-08
1787481298903903
1787481438209867
1787481593217243
1787481906335858
1787481927103602
1787482010298733

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GCJ162022-03-31
GEI112018-11-14
DXC82001-01-08
KGW52013-02-08
HET42006-08-24
FER32017-07-20
FAD32006-03-29
HEW22019-09-06
FED22003-05-23
FZP22001-05-14
EYB21994-04-18
GDW12019-11-22
BTA12012-10-02
FHF12001-02-01
FMF11998-06-11
LYK11995-02-10
KNY11994-09-21
ODC11992-03-18
DQO11991-03-25
FGE11991-03-21
DSS11988-12-27
DXT11988-05-13