FDA.reportPublic FDA data

Joni Anderson

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96175923002468371Joni Anderson1N2026-01-011 Becton Dr Franklin Lakes NJ US 07417
96814423002806368Joni 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
360971759294480P180037Venovo Venous Stent SystemQAN2019-03-13
360971489855055P170042Covera™ Vascular Covered StentPFV2018-07-30
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
361011373844132K954422PER-Q-CATH MID-LINELJS1995-12-15
361011275020994K954104PER-Q-CATH & PER-Q-CATH DUAL MUMEN CATHETERS, TRAYS & ACCESSORY DEVICESLJS1995-11-21
361011951885520K950300BARD FLEXIBLE TIP URETERAL CATHETEREYB1995-04-27
361011145183933K943663NAVARRE 600 ML DRAINAGE BAGEXF1994-09-08
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
361011433732099K910622GESCO PER-Q-CATH REPAIR KITLJS1991-03-29
361011347228780K903530PERCUTANEOUS INTRODUCERSDYB1990-10-22
361011748241025K903390MEDRAD MARK V-PLUS INJECTORDXT1990-09-26
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
361011994827074K830233NON-STERILE,SINGLE/SOUBLE LUMEN-CATHLJS1983-02-28
361011086868116K213203Provena(TM) Midline CatheterPND2022-05-13
361011017765497K171735PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle SetPTI2017-08-08
361012064834153K163458Zenysis Short-Term Dialysis CatheterMPB2017-04-04
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
361011767740942K121485GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSINGQSY2012-08-21
361011516664828K121073POWERGLIDE MIDLINE CATHETERFOZ2012-06-01
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
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
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
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
361011241535430K001901POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135LJS2000-09-19
361011024308192
361011251507258
360971628780223
361011005362573
361011008564765
361011025498031
361011028576120
361011043475507
361011043927615
361011058038920
361011064586181
361011082372179
361011091242211
361011098722451
361011114285335
361011127403173
361011132596808
361011140095247
361011155861243
361011188913735
361011189516440
361011192890628
361011205175991
361011220565067
361011224489251
361011239152177
361011247749627
361011250810394
361011257442453
361011260873380

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LJS202010-11-17
MSD62009-05-28
LJT52015-11-20
FGE52013-08-30
JAQ52009-08-19
DYB52007-10-31
MPB42017-04-04
FOZ42016-06-02
FPA32011-07-21
KNT32010-12-22
LFJ31988-06-23
PFV22018-07-30
NIE22015-06-01
DQX22015-02-20
DWM22011-05-11
NFK22006-12-05
GAA21984-09-05
PND12022-05-13
QAN12019-03-13
PTI12017-08-08
QSY12012-08-21
PNG12011-05-06
NIP12009-02-13
NIO12008-12-04
ITX12004-10-19
KNW11996-07-30
EYB11995-04-27
EXF11994-09-08
FCG11994-03-11
DXT11990-09-26
DQY11987-08-12
FMI11986-12-18