FDA.reportPublic FDA data

Dina Justice

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30041020313004102031Dina Justice1N2027-01-01950 Elkton Blvd. Elkton MD US 21921
80100262828Dina Justice1N2026-01-01950 Elkton Blvd. Elkton MD US 21921
96818343002808327Dina Justice1N2026-01-01950 Elkton Blvd. Elkton MD US 21921
96818373003753439Dina Justice1N2026-01-01950 Elkton Blvd. Elkton MD US 21921
30095009723009500972Dina Justice1N2026-01-01950 Elkton Blvd. Elkton MD US 21921
30138742913013874291Dina Justice1N2026-01-01950 Elkton Blvd. Elkton MD US 21921

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
88931480356812P140002MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEMNIP2015-05-22
88891480356812P140002MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEMNIP2015-05-22
88931989381630K992051RADIFOCUS OPTITORQUEDQO1999-08-10
88891989381630K992051RADIFOCUS OPTITORQUEDQO1999-08-10
88891760146173K991406TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETERFOZ1999-06-16
88891623404593K983490TERUMO VENOJECT,LUER ADAPTERJKA1998-11-30
88891159022741K982467CAPIOX CARDIOPLEGIADTR1999-06-23
88931159022741K982467CAPIOX CARDIOPLEGIADTR1999-06-23
88932044490868K973516CAPIOX HEMOCONCENTRATORKDI1998-01-30
88892044490868K973516CAPIOX HEMOCONCENTRATORKDI1998-01-30
88931158717837K962981CAPIOX SP PUMP HEADKFM1997-02-25
88891158717837K962981CAPIOX SP PUMP HEADKFM1997-02-25
88931673915703K955801RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLDDQX1996-02-02
88891673915703K955801RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLDDQX1996-02-02
88931429281864K943917CAPIOX ARTERIAL FILTERDTM1995-07-25
88891429281864K943917CAPIOX ARTERIAL FILTERDTM1995-07-25
88931647232998K943861CAPIOX SP PUMP HEADKFM1995-08-15
88891647232998K943861CAPIOX SP PUMP HEADKFM1995-08-15
88931653739568K926214GUIDE WIRE FOR LAPOROSCOPIC USEGCJ1993-04-29
88891653739568K926214GUIDE WIRE FOR LAPOROSCOPIC USEGCJ1993-04-29
88931698850536K924202RADIFOCUS(R) (CATHETER) GUIDE WIREDQX1992-11-23
88891698850536K924202RADIFOCUS(R) (CATHETER) GUIDE WIREDQX1992-11-23
88931178150778K923607RADIFOCUS GUIDE WIRE MKOD1992-10-02
88891178150778K923607RADIFOCUS GUIDE WIRE MKOD1992-10-02
88931878297552K915414TERUMO ANGIOGTAPHIC CATHETERDQO1992-02-04
88891878297552K915414TERUMO ANGIOGTAPHIC CATHETERDQO1992-02-04
88931848010959K9130740.016 GUIDE WIRE FOR NEUROLOGICAL ENDOSCOPEDQX1991-11-05
88891848010959K9130740.016 GUIDE WIRE FOR NEUROLOGICAL ENDOSCOPEDQX1991-11-05
88931058589076K911632CAPIOX(R) BUBBLE TRAPKRL1991-07-09
88891058589076K911632CAPIOX(R) BUBBLE TRAPKRL1991-07-09
88931005996969K910969TORQUE DEVICE FOR A GUIDE WIREDQX1991-05-16
88891005996969K910969TORQUE DEVICE FOR A GUIDE WIREDQX1991-05-16
88931261957338K863138TERUMO RADIFOCUS GUIDE WIREDQX1986-11-20
88891261957338K863138TERUMO RADIFOCUS GUIDE WIREDQX1986-11-20
88931198094022K852087CAPIOX LUER DESIGN THERMISTORS & CAPIOX CONNECTORSFLL1985-06-27
88951198094022K852087CAPIOX LUER DESIGN THERMISTORS & CAPIOX CONNECTORSFLL1985-06-27
88891198094022K852087CAPIOX LUER DESIGN THERMISTORS & CAPIOX CONNECTORSFLL1985-06-27
2104991198094022K852087CAPIOX LUER DESIGN THERMISTORS & CAPIOX CONNECTORSFLL1985-06-27
88932066137295K812659TERUMO HOLLOW OXYGENATOR CIRCUITDTM1981-12-14
88892066137295K812659TERUMO HOLLOW OXYGENATOR CIRCUITDTM1981-12-14
88891809451363K771204SURFLO WINGED INFUSION SETFPA1977-07-14
1220971676032664K252402Midline CatheterPND2025-12-18
1220971572721126K252398SURFLO Hybria Closed System Safety IV CatheterFOZ2025-12-17
88891492541046K252295RyureiLOX2026-03-27
88931492541046K252295RyureiLOX2026-03-27
88932047813818K250751DualView CatheterDQO2025-07-17
88892047813818K250751DualView CatheterDQO2025-07-17
88931371281825K240859Glidewire GT-RDQX2024-08-21
88891371281825K240859Glidewire GT-RDQX2024-08-21
88931371660832K240818R2P Radifocus Glidewire AdvantageDQX2024-11-26
88891371660832K240818R2P Radifocus Glidewire AdvantageDQX2024-11-26
1220971002120272K221411Surflo Winged Infusion SetFPA2023-06-23
1220971395220110K220934RADIFOCUS Torque DeviceMOF2022-06-29
1378121851985086K211078Progreat LambdaDQO2021-12-21
88931385028951K203521FineCross M3DQY2021-03-03
88891385028951K203521FineCross M3DQY2021-03-03
88891248316198K190427ImmuciseFMF2019-07-18
88931359239741K173799NaviCross 0.018DQY2018-03-29
88891359239741K173799NaviCross 0.018DQY2018-03-29
88892024213229K170417Glidewire GTDQX2017-09-15
88932024213229K170417Glidewire GTDQX2017-09-15
88891449074395K170223ProgreatDQO2017-07-21
88931449074395K170223ProgreatDQO2017-07-21
88891303659111K163004Radifocus Glidewire Advantage TrackDQX2017-01-30
88931303659111K163004Radifocus Glidewire Advantage TrackDQX2017-01-30
88931705480940K161546R2P SlenGuideDQY2016-10-14
88891705480940K161546R2P SlenGuideDQY2016-10-14
88931598461188K152740Radifocus GlidewireDQX2015-11-16
88891598461188K152740Radifocus GlidewireDQX2015-11-16
88931123899681K151471Radifocus Glidewire Endoscopic WireOCY2015-09-17
88891123899681K151471Radifocus Glidewire Endoscopic WireOCY2015-09-17
88931550697722K150232Radifocus Optitorque Angiographic CatheterDQO2015-10-19
88891550697722K150232Radifocus Optitorque Angiographic CatheterDQO2015-10-19
88931580129202K142183GLIDESHEATH SLENDERDYB2014-11-21
88891580129202K142183GLIDESHEATH SLENDERDYB2014-11-21
88931961549968K130520CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIRDTZ2013-03-13
88891961549968K130520CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIRDTZ2013-03-13
88931836165555K130493CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIRDTZ2013-03-13
88891836165555K130493CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIRDTZ2013-03-13
88931905088636K130280CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIRDTZ2013-03-13
88891905088636K130280CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIRDTZ2013-03-13
88931570278470K122590RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGEDQX2013-03-01
88891570278470K122590RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGEDQX2013-03-01
88931333478912K113335HEARTRAIL III GUIDING CATHETERDQO2012-07-16
88891333478912K113335HEARTRAIL III GUIDING CATHETERDQO2012-07-16
1378121057426525K112382TERUMO ASPRIATION CATHETERQEZ2011-12-14
88931248849197K110540TERUMO SUPPORT CATHETERDQY2011-05-13
88891248849197K110540TERUMO SUPPORT CATHETERDQY2011-05-13
88891956625362K100282TERUMO SURSHIELD- PUR SAFETY I.V. CATHETERFOZ2010-02-26
88891262810076K093647TRAXCESS DOCKING WIREDQX2010-02-24
88891549721095K093397TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIREDQX2009-12-17
88932073715314K092372HEARTRAIL III GUIDING CATHETERDQO2009-09-11
88892073715314K092372HEARTRAIL III GUIDING CATHETERDQO2009-09-11
88931198807322K091417SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527AOCY2009-05-22
88891198807322K091417SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527AOCY2009-05-22
88931696081132K090040RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)DQO2009-02-06
88891696081132K090040RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)DQO2009-02-06
88931394723483K082736RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETERDQO2008-09-24
88891394723483K082736RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETERDQO2008-09-24
88931672590030K082644GLIDESHEATHDYB2008-09-18
88891672590030K082644GLIDESHEATHDYB2008-09-18
88931858022477K082519FINECROSS MG CORONARY MICRO-GUIDE CATHETERKRA2008-09-26
88891858022477K082519FINECROSS MG CORONARY MICRO-GUIDE CATHETERKRA2008-09-26
88891308730229K082385CHAPERON GUIDING CATHETERDQY2008-12-11
88891078784715K080863TRAXCESS 0.014 HYDROPHILIC GUIDEWIREDQX2008-04-17
88931952954308K080774CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)KFM2008-04-17
88891952954308K080774CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)KFM2008-04-17
88931002155936K080563RUNTHROUGH NS EXTENSION WIREDQX2008-03-20
88891002155936K080563RUNTHROUGH NS EXTENSION WIREDQX2008-03-20
88931078640536K071572CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTERDTZ2007-07-23
88891078640536K071572CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTERDTZ2007-07-23
88931648907720K071494CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTERDTZ2007-07-16
88891648907720K071494CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTERDTZ2007-07-16
88931690080282K070423TR BANDDXC2007-03-28
88891690080282K070423TR BANDDXC2007-03-28
88931898282588K063695RUNTHROUGH NSDQX2007-04-27
88891898282588K063695RUNTHROUGH NSDQX2007-04-27
88931948830099K063372RADIFOCUS GLIDEWIRE ADVANTAGEDQX2007-01-19
88891948830099K063372RADIFOCUS GLIDEWIRE ADVANTAGEDQX2007-01-19
88931142026412K052205CAPIOX AF125X ARTERIAL FILTERDTM2005-09-12

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQX312024-11-26
DQO212025-07-17
DTZ162013-03-13
DQY92021-03-03
KFM62008-04-17
DTM62005-09-12
FPA42023-06-23
OCY42015-09-17
DYB42014-11-21
KRA42008-09-26
FLL41985-06-27
FOZ32025-12-17
LOX22026-03-27
NIP22015-05-22
DXC22007-03-28
DTN22004-02-10
DTR21999-06-23
KDI21998-01-30
GCJ21993-04-29
KOD21992-10-02
KRL21991-07-09
PND12025-12-18
MOF12022-06-29
FMF12019-07-18
QEZ12011-12-14
JKA11998-11-30