FDA.reportPublic FDA data

Dina Justice

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80100262828Dina Justice1N2026-01-01950 Elkton Blvd. Elkton MD US 21921
96814133001570557Dina 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
88891480356812P140002MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEMNIP2015-05-22
88931480356812P140002MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEMNIP2015-05-22
88891989381630K992051RADIFOCUS OPTITORQUEDQO1999-08-10
88931989381630K992051RADIFOCUS OPTITORQUEDQO1999-08-10
88891760146173K991406TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETERFOZ1999-06-16
1224741164273969K984576K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK II NEEDLE (HYPODERMIC NEEDLE) 25G X 1, MODEL KN-2525RB, KFMI1999-06-14
88891623404593K983490TERUMO VENOJECT,LUER ADAPTERJKA1998-11-30
88891159022741K982467CAPIOX CARDIOPLEGIADTR1999-06-23
88931159022741K982467CAPIOX CARDIOPLEGIADTR1999-06-23
88892044490868K973516CAPIOX HEMOCONCENTRATORKDI1998-01-30
88932044490868K973516CAPIOX HEMOCONCENTRATORKDI1998-01-30
88891158717837K962981CAPIOX SP PUMP HEADKFM1997-02-25
88931158717837K962981CAPIOX SP PUMP HEADKFM1997-02-25
88891673915703K955801RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLDDQX1996-02-02
88931673915703K955801RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLDDQX1996-02-02
88891429281864K943917CAPIOX ARTERIAL FILTERDTM1995-07-25
88931429281864K943917CAPIOX ARTERIAL FILTERDTM1995-07-25
88891647232998K943861CAPIOX SP PUMP HEADKFM1995-08-15
88931647232998K943861CAPIOX SP PUMP HEADKFM1995-08-15
88891653739568K926214GUIDE WIRE FOR LAPOROSCOPIC USEGCJ1993-04-29
88931653739568K926214GUIDE WIRE FOR LAPOROSCOPIC USEGCJ1993-04-29
88891698850536K924202RADIFOCUS(R) (CATHETER) GUIDE WIREDQX1992-11-23
88931698850536K924202RADIFOCUS(R) (CATHETER) GUIDE WIREDQX1992-11-23
88891178150778K923607RADIFOCUS GUIDE WIRE MKOD1992-10-02
88931178150778K923607RADIFOCUS GUIDE WIRE MKOD1992-10-02
88891878297552K915414TERUMO ANGIOGTAPHIC CATHETERDQO1992-02-04
88931878297552K915414TERUMO ANGIOGTAPHIC CATHETERDQO1992-02-04
88891848010959K9130740.016 GUIDE WIRE FOR NEUROLOGICAL ENDOSCOPEDQX1991-11-05
88931848010959K9130740.016 GUIDE WIRE FOR NEUROLOGICAL ENDOSCOPEDQX1991-11-05
88891058589076K911632CAPIOX(R) BUBBLE TRAPKRL1991-07-09
88931058589076K911632CAPIOX(R) BUBBLE TRAPKRL1991-07-09
88891005996969K910969TORQUE DEVICE FOR A GUIDE WIREDQX1991-05-16
88931005996969K910969TORQUE DEVICE FOR A GUIDE WIREDQX1991-05-16
88891261957338K863138TERUMO RADIFOCUS GUIDE WIREDQX1986-11-20
88931261957338K863138TERUMO RADIFOCUS GUIDE WIREDQX1986-11-20
88891198094022K852087CAPIOX LUER DESIGN THERMISTORS & CAPIOX CONNECTORSFLL1985-06-27
88931198094022K852087CAPIOX LUER DESIGN THERMISTORS & CAPIOX CONNECTORSFLL1985-06-27
88951198094022K852087CAPIOX LUER DESIGN THERMISTORS & CAPIOX CONNECTORSFLL1985-06-27
2104991198094022K852087CAPIOX LUER DESIGN THERMISTORS & CAPIOX CONNECTORSFLL1985-06-27
88892066137295K812659TERUMO HOLLOW OXYGENATOR CIRCUITDTM1981-12-14
88932066137295K812659TERUMO HOLLOW OXYGENATOR CIRCUITDTM1981-12-14
88891809451363K771204SURFLO WINGED INFUSION SETFPA1977-07-14
88891492541046K252295RyureiLOX2026-03-27
88931492541046K252295RyureiLOX2026-03-27
1224741491173437K251447K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)FMI2025-07-08
88892047813818K250751DualView CatheterDQO2025-07-17
88932047813818K250751DualView CatheterDQO2025-07-17
1224741301650657K243581K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)FMI2025-04-04
1224741956631707K24330927G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)FMI2025-05-29
88891371281825K240859Glidewire GT-RDQX2024-08-21
88931371281825K240859Glidewire GT-RDQX2024-08-21
88891371660832K240818R2P Radifocus Glidewire AdvantageDQX2024-11-26
88931371660832K240818R2P Radifocus Glidewire AdvantageDQX2024-11-26
1224741876607111K230951Terumo Injection Filter Needle (NF-3013RBKE05M)QYM2023-10-18
1224741686730407K212095SurGuard3 Safety Hypodermic NeedleFMI2022-08-22
1378121851985086K211078Progreat LambdaDQO2021-12-21
88891385028951K203521FineCross M3DQY2021-03-03
88931385028951K203521FineCross M3DQY2021-03-03
1224741968850549K192057K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin Wall, K-Pack II Needle - 30G x 1/2” Extra Thin Wall, K-Pack II Needle - 30G x 1/2” Ultra Thin WallFMI2019-10-11
88891248316198K190427ImmuciseFMF2019-07-18
88891359239741K173799NaviCross 0.018DQY2018-03-29
88931359239741K173799NaviCross 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
1224742067070859K161606Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSHFMF2017-02-10
88891705480940K161546R2P SlenGuideDQY2016-10-14
88931705480940K161546R2P SlenGuideDQY2016-10-14
88891598461188K152740Radifocus GlidewireDQX2015-11-16
88931598461188K152740Radifocus GlidewireDQX2015-11-16
1224741676043412K152362Terumo SurGuard 3 Safety Hypodermic NeedleFMI2015-10-16
88891123899681K151471Radifocus Glidewire Endoscopic WireOCY2015-09-17
88931123899681K151471Radifocus Glidewire Endoscopic WireOCY2015-09-17
1224741206760858K151398K-Pack II Needle - 29G x 5/16 Thin WallFMI2015-06-25
1224741969075110K150263K-Pack II Needle-21G x 2FMI2015-04-01
88891550697722K150232Radifocus Optitorque Angiographic CatheterDQO2015-10-19
88931550697722K150232Radifocus Optitorque Angiographic CatheterDQO2015-10-19
88891580129202K142183GLIDESHEATH SLENDERDYB2014-11-21
88931580129202K142183GLIDESHEATH SLENDERDYB2014-11-21
1224741712144220K133894SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD)FPA2014-03-18
1224741750502050K133867SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)FPA2014-02-05
1224742020623443K132233K-PACK II NEEDLE - 27G X 3/4 THIN WALLFMI2013-09-06
1224741395048330K130520CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIRDTZ2013-03-13
88891961549968K130520CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIRDTZ2013-03-13
88931961549968K130520CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIRDTZ2013-03-13
88891836165555K130493CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIRDTZ2013-03-13
88931836165555K130493CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIRDTZ2013-03-13
88891905088636K130280CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIRDTZ2013-03-13
88931905088636K130280CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIRDTZ2013-03-13
88891570278470K122590RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGEDQX2013-03-01
88931570278470K122590RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGEDQX2013-03-01
1224741230356597K122249TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLEFMI2012-08-28
1224741728475147K113422TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLEFMI2012-03-05
88891333478912K113335HEARTRAIL III GUIDING CATHETERDQO2012-07-16
88931333478912K113335HEARTRAIL III GUIDING CATHETERDQO2012-07-16
1378121057426525K112382TERUMO ASPRIATION CATHETERQEZ2011-12-14
1224741983876283K11179727 G X 1/2 K-PACK SURSHIELD NEEDLEFMI2011-09-22
1224741904682070K110850K-PACK II NEEDLE- 27G & 30G THIN WALLFMI2011-06-09
88891248849197K110540TERUMO SUPPORT CATHETERDQY2011-05-13
88931248849197K110540TERUMO SUPPORT CATHETERDQY2011-05-13
1224741845967739K110527K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USEFMI2011-06-06
1224741053178809K100946INTRAVSCULAR ADMINISTRATION SETFPA2010-08-02
88891956625362K100282TERUMO SURSHIELD- PUR SAFETY I.V. CATHETERFOZ2010-02-26
88891262810076K093647TRAXCESS DOCKING WIREDQX2010-02-24
88891549721095K093397TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIREDQX2009-12-17
88892073715314K092372HEARTRAIL III GUIDING CATHETERDQO2009-09-11
88932073715314K092372HEARTRAIL III GUIDING CATHETERDQO2009-09-11
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
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
88891696081132K090040RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)DQO2009-02-06
88931696081132K090040RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)DQO2009-02-06
1224741204982085K082820K-PACK II NEEDLE - 29G THIN WALLFMI2008-10-23
88891394723483K082736RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETERDQO2008-09-24
88931394723483K082736RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETERDQO2008-09-24
88891672590030K082644GLIDESHEATHDYB2008-09-18
88931672590030K082644GLIDESHEATHDYB2008-09-18
88891858022477K082519FINECROSS MG CORONARY MICRO-GUIDE CATHETERKRA2008-09-26

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQX312024-11-26
DQO212025-07-17
DTZ182013-03-13
FMI172025-07-08
DQY92021-03-03
KFM62008-04-17
DTM62005-09-12
FPA52014-03-18
OCY42015-09-17
DYB42014-11-21
KRA42008-09-26
FLL41985-06-27
FMF32019-07-18
LOX22026-03-27
NIP22015-05-22
FOZ22010-02-26
DXC22007-03-28
DTN22004-02-10
DTR21999-06-23
KDI21998-01-30
GCJ21993-04-29
KOD21992-10-02
KRL21991-07-09
QYM12023-10-18
QEZ12011-12-14
MEG12005-09-27
JKA11998-11-30