FDA.reportPublic FDA data

Applied Medical Distribution Center

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30090518883009051888Applied Medical Distribution Center1Y2026-01-019401 Toledo Way Irvine CA US 92618

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1517761111636336K993650URETERAL ACCESS SHEATH SET - NEW MODELSFED1999-12-28
1517761506564538K993135IMPLANTABLE CLIP FOR GENERAL SURGERYFZP1999-12-01
1517761542190659K991219C-FLEX URETERAL STENTSFAD1999-06-21
1517761527678944K980987BECTON DICKINSON SYRINGEFMF1998-06-11
1517761248100587K973465LATIS GRAFT CLEANING CATHETERDXE1998-02-19
1517761529196059K970762DUAL LUMEN EMBOLECTOMY CATHETERDXE1997-03-28
1517761377322711K963359INSUFFLATION NEEDLEHET1996-09-24
1517761833204696K962668AMR-ACV CLAMPSDXC1996-11-04
1517761059252139K950586AVD INTIMAX THROMBECTOMY CATHETERDXE1995-05-15
1517761638455619K950492ATRAUMAX SURGICAL CLAMPDXC1995-05-08
1517761977121392K945591APPLIED MEDICAL OPTICAL VALVULOTOMELYK1995-02-10
1517761077592249K944135UROLOGICAL GUIDWIREKNY1994-09-21
1517761505856789K943489DISPOSABLE SURGICAL TROCARGCJ1994-08-09
1517761140768919K941012LOW PRESSURE TAMPONADE BALLOON CATHETEREYB1994-04-18
1517761140621589K932995SURGICAL TROCAR AND CANNULAGCJ1993-09-23
1517761144427289K931895ENDOSCOPE ACCESSORYGCJ1993-09-07
1517761650560157K923636TROCAR W/ BLUNT TIP OBTURATORHET1993-11-05
1517761372061309K921838ACUCISE URETERAL CUTTING CATHETEREYB1993-02-26
1517761406317621K920030SURESEAL ENDOSCOPIC VALVEODC1992-03-18
1517761956717426K911181INTIMAX(TM) IRRIGATION CATHETERGCA1991-04-18
1517761353839459K910493AVD INTIMAX CHOLANGIOGRAPHY CATHETERFGE1991-03-28
1517761843139089K910372INTIMAX THROMBECTOMY CATHETERDXE1991-04-26
1517761055890976K910006AVD INTIMAX (TM) BILIARY CATHETERFGE1991-02-13
1517761430148382K905738OPERATIVE CHOLANGIOGRAPHIC CATHETERFGE1991-03-21
1517761104296000K903848DIAGNOSTIC INTRASCULAR CATHETERDQO1991-03-25
1517761549883341K902256IRRIGATION CATHETER 4, 6 AND 10 FRENCHDQY1991-02-15
1517761395379831K901628APPLIED VASCULAR DEVICES 6MM TRACTION CLIPDXC1990-07-06
1517761019212085K901627ARTERIAL EMBOLECTOMY CATHETERDXE1990-10-19
1517761974658392K901565ATRAUMAX SURGICAL CLAMP MODEL FOG-5048, 75MM SIDEDXC1990-06-12
1517762027106207K895691VASCULAR CLAMPDXC1989-12-13
1517761625189987K891296ATRAUMAX(TM) SURGICAL CLAMPSDXC1989-06-07
1517761402810198K883909SURGICAL SPRING CLIPSDSS1988-12-27
1517761109723200K883790SURGICAL CLAMP INSERTSDXC1988-12-27
1517761291448936K880987INJECTOR HANDLE WITH SYRINGEDXT1988-05-13
1517761299351422K253531Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)KGW2026-02-23
1517761137517190K243152GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceHEW2025-10-02
1517761753392493K232880Inzii Ripstop Redeployable Retrieval SystemGCJ2023-11-01
1517761405388215K222284Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)GEI2022-10-14
1517761115965782K220969GelPOINT V-Path Vaginal Access SystemMOK2022-09-16
1517762031022648K211043Alexis Contained Extraction SystemGCJ2022-03-31
1517761165961951K202818Voyant Fine Fusion Device (EB230)GEI2021-12-16
1517761178856500K201212Voyant Open Fusion DeviceGEI2020-06-05
1517761492529352K200598Voyant Maryland Fusion DeviceGEI2020-04-08
1517761000114303K191294Transvaginal Access PlatformHEW2019-09-06
1517761746619779K190331Applied Medical Laparoscopic Linear CutterGDW2019-11-22
1517761596740812K182653Voyant Maryland Fusion DeviceGEI2018-11-14
1517761948034507K182244Voyant Electrosurgical GeneratorGEI2018-10-11
1517761119058631K182024Dissecting Balloon SystemGCJ2018-08-30
1517761875879990K180699Voyant Open Fusion DeviceGEI2018-04-13
1517761496533614K172624Voyant 5mm Fusion DeviceGEI2018-02-13
1517761020755010K171701GelPOINT Path Transanal Access PlatformFER2017-07-20
1517761809521213K171684Epix Electrosurgical Probe with Smoke EvacuationGEI2017-08-07
1517761906981758K162676Voyant Open Fusion DeviceGEI2016-12-01
1517761322528095K153017Voyant Fine FusionGEI2016-07-06
1517761422829029K151480Epix Electrosurgical Probe with Smoke EvacuationGEI2016-02-19
1517761339799956K143308GelPOINT Transvaginal Access PlatformHEW2015-10-13
1517762043297367K142427TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25GCJ2014-12-23
1517761695938854K141288VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICEGEI2014-08-22
1517761447531040K133393GELPOINT PATH TRANSANAL ACCESS PLATFORMFER2014-01-02
1517761073281940K132300EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, REGEI2014-01-24
1517761340184936K122619EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SETBTA2012-10-02
1517761080976531K113268ALEXIS O WOUND PROTECTOR/RETRACTORKGW2013-02-08
1517761026734310K110792GELPOINT PATHFER2011-05-23
1517761184345470K103282LAPAROSCOPIC DISSECTORGEI2010-11-16
1517761040792889K100959SPECIMEN RETRIEVAL SYSTEMGCJ2010-04-22
1517762068660443K100120ALEXIS ORTHOPAEDIC WOUND RETRACTORKGW2010-04-02
1517761562737732K093296ALEXIS LAPAROSCOPIC SYSTEMKGW2009-11-05
1517761894847465K090275GELPORT SINGLE INCISION ACCESS SYSTEMGCJ2009-02-18
1517761721005382K083638FIXATION TROCARSGCJ2008-12-23
1517762060383859K072674KII TROCAR SYSTEMGCJ2007-10-05
1517761404249633K062907ALEXIS WOUND RETRACTORKGW2007-01-09
1517761867361539K062169APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORSHET2006-08-24
1517761984965532K060673PEDIATRIC URETERAL STENTFAD2006-03-29
1517761777340991K060629GELPORT BLUNT TIP TROCAR SYSTEMGCJ2006-04-07
1517761544758685K060534INTUITIVE SURGICAL SEALGCJ2006-03-13
1517761560083087K060096MODULAR TROCAR SYSTEMGCJ2006-01-24
1517762014348544K060051SPECIMEN RETRIEVAL SYSTEMGCJ2006-01-19
1517761426983339K041795MODIFICATION TO OPTICAL SEPARATOR SYSTEMGCJ2004-09-14
1517761388913102K041711ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304KGW2004-08-26
1517761649681558K040760MODIFICATION TO URETERAL STENTFAD2004-10-15
1517761057625121K040295APPLIED LAPAROSCOPIC MONOPOLAR SCISSORSHET2004-03-12
1517761811282318K032889OPTICAL SEPARATORGCJ2003-10-02
1517761053799340K030642DEFLECTING URETERAL ACCESS SHEATHFED2003-05-23
1517761927675236K014047APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICEGCJ2002-02-28
1517761582555126K011236MODIFICATION TO IMPLANTABLE CLIPFZP2001-05-14
1517761692084712K003443SUCTION IRRIGATORFHF2001-02-01
1517761770073585K002915FLEXIBLE OCCLUSION SYSTEMDXC2001-01-08
1517761931945294
1517761298903903
1517761438209867
1517761593217243
1517761685343469
1517761906335858
1517761927103602
1517762010298733

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GCJ182023-11-01
GEI152022-10-14
DXC82001-01-08
KGW62026-02-23
DXE51998-02-19
HET42006-08-24
HEW32025-10-02
FER32017-07-20
FAD32006-03-29
FGE31991-03-28
FED22003-05-23
FZP22001-05-14
EYB21994-04-18
MOK12022-09-16
GDW12019-11-22
BTA12012-10-02
FHF12001-02-01
FMF11998-06-11
LYK11995-02-10
KNY11994-09-21
ODC11992-03-18
GCA11991-04-18
DQO11991-03-25
DQY11991-02-15
DSS11988-12-27
DXT11988-05-13