FDA.reportPublic FDA data

Joni Anderson

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80406073002806591Joni Anderson1N2027-01-011 Becton Dr Franklin Lakes NJ US 07417
96160673001436772Joni Anderson1N2027-01-011 Becton Dr Franklin Lakes NJ US 07417
96166663008906816Joni Anderson1N2027-01-011 Becton Dr Franklin Lakes NJ US 07417
96814423002806368Joni Anderson1N2027-01-011 Becton Dr Franklin Lakes NJ US 07417
96175923002468371Joni Anderson1N2026-01-011 Becton Dr Franklin Lakes NJ US 07417

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
360971511977884P250050Liverty™ TIPS Stent GraftMIR2026-09-25
360971759294480P180037Venovo Venous Stent SystemQAN2019-03-13
360971489855055P170042Covera™ Vascular Covered StentPFV2018-07-30
1366071549833751P160024LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENTPRL2017-04-24
360971001387635P080007BARD E-LUMINEXX VASCULAR STENTNIO2008-12-04
360971319940737P070014LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEMNIP2009-02-13
360971979670699P060002FLAIR ENDOVASCULAR STENT GRAFTPFV2007-07-23
361011441992153K993848MILLENNIUM HUBER PLUS SAFETY INFUSION SETFPA2000-01-27
361011274882415K993000BARD HYDROPHILIC COATED GUIDE WIRESDQX1999-11-02
361011333831824K962077BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACERKNW1996-07-30
361002065971817K961492HYDRO-SURG LAPAROSCOPIC IRRIGATON MODELS 0026000. 0026010GCJ1996-05-15
361001085026442K961271USCI COMMANDER SERIES GUIDE WIRESDQX1996-06-27
361011373844132K954422PER-Q-CATH MID-LINELJS1995-12-15
361011275020994K954104PER-Q-CATH & PER-Q-CATH DUAL MUMEN CATHETERS, TRAYS & ACCESSORY DEVICESLJS1995-11-21
360661308305285K951260URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANTKOD1995-09-27
361001639513359K951086NEZHAT-DORSEY HYDRO-DISSECTION SYSTEM AND ACCESSORIESGCJ1995-03-16
361011951885520K950300BARD FLEXIBLE TIP URETERAL CATHETEREYB1995-04-27
361011145183933K943663NAVARRE 600 ML DRAINAGE BAGEXF1994-09-08
361001552965357K942886SIMPULSE SOLO SUCTION IRRIGATORFQH1994-07-19
361001715211912K941334DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBEHET1994-06-14
361011508600562K9263313.0 FR GROSHONG PERIPHER INSERT CENT VENOUS CATHLJS1994-03-07
361011529270858K915841BARD GAUDERER UNIVERSAL PERCUTANEOUS ENDOSCOPICKNT1993-06-25
361011596782597K915837NON-BALLOON REPLACEMENT GASTROSTOMY SYSTEMKNT1993-03-23
361011446799131K915801BIP-COAX-SYSTEMFCG1994-03-11
361011302568869K915167GESCO PER-Q-CATH CATHETER INTRODUCERDYB1992-01-27
361001880911280K914526DAVOL ENDO-FLO SUCT/IRRI PROBE (FOR GEN SURGERY)GCJ1991-11-22
361001952380650K914119DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEMCAC1992-12-03
361002012134402K913944NEZHAT/DORSEY HYDRO DISSECTION PUMP & ACCESSORIESHET1992-03-09
361001742480917K913247SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEMCAC1993-02-25
361011433732099K910622GESCO PER-Q-CATH REPAIR KITLJS1991-03-29
361011347228780K903530PERCUTANEOUS INTRODUCERSDYB1990-10-22
361011748241025K903390MEDRAD MARK V-PLUS INJECTORDXT1990-09-26
361002043185362K902722BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEMHET1990-11-16
361001194965168K896118NEZHAT/DORSEY HYDRO DISSECTION PUMP OB-GYN USEHET1990-03-28
361011274743694K881743VAS-CATH FLEXXICON DUAL LUMEN DIALYSIS CATHETERLFJ1988-06-23
361011494092634K880571CATH-TECH PORT IMPLANTABLE VASCULAR ACCESS SYSTEMLJT1988-03-04
361011573255441K871488VAS-CATH PERMANENT DUAL LUMEN HEMODIALYSIS CATHLFJ1987-06-12
361012073605080K871080PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERDQY1987-08-12
361011723960493K870260HICKMAN TITANIUM SUBCUTANEOUS PORTLJT1987-04-15
361011834748142K863606BUTTERFLY NON-CORING NEEDLE SETFMI1986-12-18
361011043927615K860432PERCUTANEOUS INTRODUCER KITDYB1986-03-31
361011962523168K844433VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CANNULALFJ1985-03-13
360971682969405K843083CORMED HUBER POINT NEEDLEGAA1984-09-05
361011682969405K843083CORMED HUBER POINT NEEDLEGAA1984-09-05
361001184746000K830386DAVOL SURGICAL SUCTION IRRIGATION INSTRFQH1983-03-29
361011994827074K830233NON-STERILE,SINGLE/SOUBLE LUMEN-CATHLJS1983-02-28
1366071916396666K222793WavelinQ™ GeneratorGEI2022-10-17
361011086868116K213203Provena(TM) Midline CatheterPND2022-05-13
1366071589819207K212708Halo One Thin-Walled Guiding SheathDYB2021-09-23
1366072039529392K192313Halo One Thin-Walled Guiding SheathDYB2019-12-19
1366071735491724K192239WavelinQ Plus EndoAVF SystemPQK2019-10-17
1366071927278284K191532The Caterpillar and Caterpillar Micro Arterial Embolization DevicesKRD2020-02-04
361011017765497K171735PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle SetPTI2017-08-08
361012064834153K163458Zenysis Short-Term Dialysis CatheterMPB2017-04-04
1366071594950991K162656ESU-1 Electrosurgical GeneratorGEI2016-11-10
361011166809532K153298AccuCath Intravascular CatheterFOZ2015-12-10
361011035312373K153280PowerGlide Pro Midline CatheterFOZ2016-06-02
361011862423587K150514Power-Injectable Implantable Ports with ChronoFlex Polyurethane CathetersLJT2015-11-20
361011892488677K143135Spring Coil GuidewireDQX2015-02-20
361011877329914K141531POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETERNIE2015-06-01
361011168305174K133456POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETERNIE2014-09-24
360971183885759K130792LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEMFGE2013-08-30
1366071568444060K130786SLEEK OTW PTA CATHETERLIT2013-05-03
361002051559057K122785HYDROSIL; MAGIC; PERSONAL CATHETEREZD2013-05-14
361011767740942K121485GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSINGQSY2012-08-21
361011516664828K121073POWERGLIDE MIDLINE CATHETERFOZ2012-06-01
361001853828832K112791SITESCRUB IPA DEVICELKB2012-02-24
361011625325896K110409ASPIRA PLEURAL DRAINAGE SYSTEMDWM2011-05-11
361011676854290K110396ASPIRA PERITONEAL DRAINAGE SYSTEMPNG2011-05-06
361011630221286K103109PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBEKNT2010-12-22
361011945530756K102405INFUSION SET FOR POWERPICC SOLO 2 CATHETERFPA2011-07-21
361011663954166K102159POWERPICC SV CATHETERSLJS2010-11-17
1366071042359605K102035SLEEK OTW PTA CATHETERSLIT2010-12-01
361011061737754K092323CONTURA CAVITY MAINTENANCE CATHETERJAQ2009-08-19
361011793281838K091324SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLETLJS2009-08-07
361011135281842K090528DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KITMSD2009-05-28
361011590887778K090512POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETERLJT2009-03-27
361011940665351K090102NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERSMPB2009-02-12
361011509761218K082264CONTURA LUMEN MARKERJAQ2008-09-12
361011337759969K081079CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPYJAQ2008-05-02
361011334274897K080791CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45JAQ2008-04-30
1366071384561573K072947SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERSLIT2008-02-08
361011711997316K072230POWERPICC SOLOLJS2007-10-05
361011426347073K072130PTFE PEEL AWAY MICROINTRODUCERDYB2007-10-31
361012067710867K071229SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPYJAQ2007-05-18
361011626968462K071095ASPIRA PLEURAL DRAINAGE SYSTEMDWM2007-05-18
361011158432733K0709964 FR SINGLE LUMEN (SL) POWERPICC CATHETERLJS2007-05-08
361011705326836K063848POWERGROSHONG PICC CATHETERLJS2007-04-04
360971912208786K063532BARD E LUMINEXX BILIARY STENTFGE2008-05-30
361011938649450K063240SHERLOCK TLS STYLET, SHERLOCK TLS DETECTORLJS2006-11-21
361011651265994K062435REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERSNFK2006-12-05
360971467465479K060487LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEMFGE2006-03-23
361011759125280K060341SHERLOCK TIP LOCATION SYSTEM (TLS)FOZ2006-04-14
361011053755260K053589LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATINGMSD2006-04-13
361011635774305K053501POWERPICCLJS2006-01-13
360971992171367K053404LIFESTENT FLEXSTART BILIARY STENT SYSTEMFGE2005-12-21
361011844001452K051991POWERPICC, POLY PER-Q-CATH, 6 FR TL POLY PER-Q-CATH, POWER HOHN AND POWER LINELJS2005-10-20
361012071451596K051748HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERSMSD2005-08-12
361011618611354K051672POWERPICCLJS2005-11-23
361011505420543K0509316 FR DL POWERPICC CATHETERLJS2005-06-15
361011725470855K050600MINILOC SAFETY INFUSION SETFPA2005-05-12
361011516319409K050023SECURELOC; ADVANCINTRODUCERDYB2005-02-18
361011772637393K042445SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KITITX2004-10-19
361011521385874K034065MODIFICATION TO X-PORT DUO PORTLJT2004-01-15
361011009469630K034020GROSHONG NXT PICC CATHETERSLJS2004-01-21
361011670406251K034019POLY PER-Q-CATH PICC CATHETERSLJS2004-01-21
361001766336389K033477HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KITMJC2004-06-10
361011001515279K033389POWERPICC CATHETERS, MODELS 3175155, 3175135LJS2004-03-19
360971257830152K031186LUMINEXX ENDOSCOPIC BILIARY STENTFGE2003-05-06
361011648388231K030277SOFT-CELL DUAL LUMEN CATHETERSMSD2003-08-06
361011661153663K030268NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETERSMPB2003-07-30
361011656944101K023374GROSHONG NXT DUAL LUMEN PICC CATHETERSLJS2002-12-18
361011191788632K022644RETRO REPAIR KIT, MODEL PRRK5NFK2002-11-06
361011994739567K022000POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES)MSD2002-07-19
361011160416845K010778NIAGARA SLIM-CATHMPB2001-04-13
361011698490980K010567OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETRMSD2001-03-28
361001269767395K003790DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005GCJ2000-12-22
361011241535430K001901POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135LJS2000-09-19
361001111648043K001143RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETERMJC2000-07-07
361001861667305K000723HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)KOD2000-05-19

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LJS202010-11-17
DYB72021-09-23
MSD62009-05-28
LJT52015-11-20
FGE52013-08-30
JAQ52009-08-19
MPB42017-04-04
FOZ42016-06-02
GCJ42000-12-22
HET41994-06-14
DQX32015-02-20
LIT32013-05-03
FPA32011-07-21
KNT32010-12-22
LFJ31988-06-23
GEI22022-10-17
PFV22018-07-30
NIE22015-06-01
DWM22011-05-11
NFK22006-12-05
MJC22004-06-10
KOD22000-05-19
FQH21994-07-19
CAC21993-02-25
GAA21984-09-05
PND12022-05-13
KRD12020-02-04
PQK12019-10-17
QAN12019-03-13
PTI12017-08-08
PRL12017-04-24
EZD12013-05-14
QSY12012-08-21
LKB12012-02-24
PNG12011-05-06
NIP12009-02-13
NIO12008-12-04
ITX12004-10-19
KNW11996-07-30
EYB11995-04-27