Dina Justice

FDA Filings

This page includes the latest FDA filings for Dina Justice. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number9681834
FEI Number3002808327
NameDina Justice
Owner & OperatorTERUMO CORP.
Contact Address44-1, 2-CHOME, HATAGAYA --
SHIBUYA-KU, TOKYO JP-NOTA 151-0072 JP
US Agent
Importing Logistics Registration
ImporterISLALAB Products Corp
AddressDiana Street Lot 13 Amelia Industrial Park
Guaynabo, PR 00968 UNITED STATES
Phone1 787 7922222
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address950 ELKTON BLVD.
ELKTON, MD 21921 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number9681835
FEI Number3003752255
NameDina Justice
Owner & OperatorTERUMO CORP.
Contact Address44-1, 2-CHOME, HATAGAYA --
SHIBUYA-KU, TOKYO JP-NOTA 151-0072 JP
US Agent
Importing Logistics Registration
ImporterISLALAB Products Corp
AddressDiana Street Lot 13 Amelia Industrial Park
Guaynabo, PR 00968 UNITED STATES
Phone1 787 7922222
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address950 ELKTON BLVD.
ELKTON, MD 21921 US
Establishment TypeManufacture Medical Device

Registration Number8010026
FEI Number2828
NameDina Justice
Owner & OperatorTERUMO CORP.
Contact Address44-1, 2-CHOME, HATAGAYA --
SHIBUYA-KU, TOKYO JP-NOTA 151-0072 JP
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address950 Elkton Blvd
Elkton, 21921 US
Establishment TypeExport Device to the United States But Perform No Other Operation on Device

Registration Number9681839
FEI Number3002808337
NameDina Justice
Owner & OperatorTERUMO CORP.
Contact Address44-1, 2-CHOME, HATAGAYA --
SHIBUYA-KU, TOKYO JP-NOTA 151-0072 JP
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address950 ELKTON BLVD.
ELKTON, MD 21921 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
Dina Justice [TERUMO CORP.]
NaviCross 0.018"2018-04-05
Dina Justice [TERUMO CORP.]
NaviCross 0.018"2018-04-05
Dina Justice [TERUMO CORP.]
Glidewire GT2017-09-20
Dina Justice [TERUMO CORP.]
Glidewire GT2017-09-20
Dina Justice [TERUMO CORP.]
Progreat2017-09-08
Dina Justice [TERUMO CORP.]
Progreat2017-09-08
Dina Justice [TERUMO CORP.]
Radifocus Glidewire Advantage Track2017-02-03
Dina Justice [TERUMO CORP.]
Radifocus Glidewire Advantage Track2017-02-03
Dina Justice [TERUMO CORP.]
R2P SlenGuide2016-12-16
Dina Justice [TERUMO CORP.]
R2P SlenGuide2016-12-16
Dina Justice [TERUMO CORP.]
Radifocus Glidewire2015-11-17
Dina Justice [TERUMO CORP.]
Radifocus Glidewire2015-11-17
Dina Justice [TERUMO CORP.]
Radifocus? Optitorque? Angiographic Catheter2015-10-23
Dina Justice [TERUMO CORP.]
Radifocus? Optitorque? Angiographic Catheter2015-10-23
Dina Justice [TERUMO CORP.]
Radifocus Glidewire? Endoscopic Wire2015-09-18
Dina Justice [TERUMO CORP.]
Radifocus Glidewire? Endoscopic Wire2015-09-18
Dina Justice [TERUMO CORP.]
MISAGO RX Self-expanding Peripheral Stent2015-05-27
Dina Justice [TERUMO CORP.]
MISAGO RX Self-expanding Peripheral Stent2015-05-27
Dina Justice [TERUMO CORP.]
CAPIOX SP Pump Head2015-04-24
Dina Justice [TERUMO CORP.]
CAPIOX SP Pump Head2015-04-24
Dina Justice [TERUMO CORP.]
CAPIOX SP Pump (With or Without X-Coating)2015-04-24
Dina Justice [TERUMO CORP.]
CAPIOX SP Pump (With or Without X-Coating)2015-04-24
Dina Justice [TERUMO CORP.]
Glidesheath Slender2014-12-04
Dina Justice [TERUMO CORP.]
Glidesheath Slender2014-12-04
Dina Justice [TERUMO CORP.]
Radifocus Glidewire Advantage 0.0142013-04-04
Dina Justice [TERUMO CORP.]
Radifocus Glidewire Advantage 0.0142013-04-04
Dina Justice [TERUMO CORP.]
CAPIOX FX15 and FX25 Hollow Fiber Oxygenator/Reservoir with Integrated Arterial Filter (with X-Coating)2013-03-20
Dina Justice [TERUMO CORP.]
CAPIOX FX15 and FX25 Hollow Fiber Oxygenator/Reservoir with Integrated Arterial Filter (with X-Coating)2013-03-20
Dina Justice [TERUMO CORP.]
CAPIOX RX05 Hollow Fiber Oxygenator/Reservoir (with X-Coating)2013-03-20
Dina Justice [TERUMO CORP.]
CAPIOX RX05 Hollow Fiber Oxygenator/Reservoir (with X-Coating)2013-03-20
Dina Justice [TERUMO CORP.]
CAPIOX FX05 Hollow Fiber Oxygenators/Reservoirs with Integrated Arterial Filter (with X-Coating)2013-03-20
Dina Justice [TERUMO CORP.]
CAPIOX FX05 Hollow Fiber Oxygenators/Reservoirs with Integrated Arterial Filter (with X-Coating)2013-03-20
Dina Justice [TERUMO CORP.]
Heartrail III 5Fr Guiding Catheter2012-07-18
Dina Justice [TERUMO CORP.]
Heartrail III 5Fr Guiding Catheter2012-07-18
Dina Justice [TERUMO CORP.]
Terumo NaviCross Support Catheter2011-05-27
Dina Justice [TERUMO CORP.]
Terumo NaviCross Support Catheter2011-05-27
Dina Justice [TERUMO CORP.]
TRAXCESS DOCKING WIRE2010-03-01
Dina Justice [TERUMO CORP.]
TRAXCESS DOCKING WIRE2010-03-01
Dina Justice [TERUMO CORP.]
TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE2009-12-18
Dina Justice [TERUMO CORP.]
TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE2009-12-18
Dina Justice [TERUMO CORP.]
Heartrail III Coronary Guiding Catheter2009-09-15
Dina Justice [TERUMO CORP.]
Heartrail III Coronary Guiding Catheter2009-09-15
Dina Justice [TERUMO CORP.]
Single Use Guidewire G-240-2527S2009-05-26
Dina Justice [TERUMO CORP.]
Single Use Guidewire G-240-2527S2009-05-26
Dina Justice [TERUMO CORP.]
G-240-3545S2009-05-26
Dina Justice [TERUMO CORP.]
G-240-3545S2009-05-26
Dina Justice [TERUMO CORP.]
G-240-3545A VisiGlide Single Use Guidewire2009-05-26
Dina Justice [TERUMO CORP.]
G-240-3545A VisiGlide Single Use Guidewire2009-05-26
Dina Justice [TERUMO CORP.]
G-240-3527S2009-05-26
Dina Justice [TERUMO CORP.]
G-240-3527S2009-05-26
Dina Justice [TERUMO CORP.]
G-240-3527A2009-05-26
Dina Justice [TERUMO CORP.]
G-240-3527A2009-05-26
Dina Justice [TERUMO CORP.]
G-240-2545S2009-05-26
Dina Justice [TERUMO CORP.]
G-240-2545S2009-05-26
Dina Justice [TERUMO CORP.]
G-240-2545A2009-05-26
Dina Justice [TERUMO CORP.]
G-240-2545A2009-05-26
Dina Justice [TERUMO CORP.]
G-240-2527A2009-05-26
Dina Justice [TERUMO CORP.]
G-240-2527A2009-05-26
Dina Justice [TERUMO CORP.]
Radifocus Glidecath2009-02-10
Dina Justice [TERUMO CORP.]
Radifocus Glidecath2009-02-10
Dina Justice [TERUMO CORP.]
CHAPERON GUIDING CATHETER2008-12-11
Dina Justice [TERUMO CORP.]
CHAPERON GUIDING CATHETER2008-12-11
Dina Justice [TERUMO CORP.]
Radifocus Optitorque Angiographic Catheter2008-10-06
Dina Justice [TERUMO CORP.]
Radifocus Optitorque Angiographic Catheter2008-10-06
Dina Justice [TERUMO CORP.]
Optitorque2008-10-06
Dina Justice [TERUMO CORP.]
Optitorque2008-10-06
Dina Justice [TERUMO CORP.]
Obturator2008-10-06
Dina Justice [TERUMO CORP.]
Obturator2008-10-06
Dina Justice [TERUMO CORP.]
Glidesheath2008-10-06
Dina Justice [TERUMO CORP.]
Glidesheath2008-10-06
Dina Justice [TERUMO CORP.]
Finecross MG Coronary Micro-Guide Catheter2008-10-06
Dina Justice [TERUMO CORP.]
Finecross MG Coronary Micro-Guide Catheter2008-10-06
Dina Justice [TERUMO CORP.]
with Integrated Arterial Filter2008-07-25
Dina Justice [TERUMO CORP.]
with Integrated Arterial Filter2008-07-25
Dina Justice [TERUMO CORP.]
CAPIOX FX05 Hollow Fiber Oxygenator2008-07-25
Dina Justice [TERUMO CORP.]
CAPIOX FX05 Hollow Fiber Oxygenator2008-07-25
Dina Justice [TERUMO CORP.]
with Integrated Arterial Filter2008-07-25
Dina Justice [TERUMO CORP.]
with Integrated Arterial Filter2008-07-25
Dina Justice [TERUMO CORP.]
CAPIOX FX Hollow Fiber Oxygenator2008-07-25
Dina Justice [TERUMO CORP.]
CAPIOX FX Hollow Fiber Oxygenator2008-07-25
Dina Justice [TERUMO CORP.]
TRAXCESS 0.014" HYDROPHILIC GUIDEWIRE2008-05-05
Dina Justice [TERUMO CORP.]
TRAXCESS 0.014" HYDROPHILIC GUIDEWIRE2008-05-05
Dina Justice [TERUMO CORP.]
Runthrough NS Extension Wire2008-03-24
Dina Justice [TERUMO CORP.]
Runthrough NS Extension Wire2008-03-24
Dina Justice [TERUMO CORP.]
Radifocus Optitorque Angiographic Catheter2007-11-30
Dina Justice [TERUMO CORP.]
Radifocus Optitorque Angiographic Catheter2007-11-30
Dina Justice [TERUMO CORP.]
CAPIOX Cardioplegia2007-11-30
Dina Justice [TERUMO CORP.]
CAPIOX Cardioplegia2007-11-30
Dina Justice [TERUMO CORP.]
Capiox Hemoconcentrator2007-11-30
Dina Justice [TERUMO CORP.]
Capiox Hemoconcentrator2007-11-30
Dina Justice [TERUMO CORP.]
Headliner Hydrophilic Coated Guidewire2007-11-30
Dina Justice [TERUMO CORP.]
Headliner Hydrophilic Coated Guidewire2007-11-30
Dina Justice [TERUMO CORP.]
Glidewire Gold Neuro Neuro Glidewires2007-11-30
Dina Justice [TERUMO CORP.]
Glidewire Gold Neuro Neuro Glidewires2007-11-30
Dina Justice [TERUMO CORP.]
CAPIOX Arterial Filter2007-11-30
Dina Justice [TERUMO CORP.]
CAPIOX Arterial Filter2007-11-30
Dina Justice [TERUMO CORP.]
Capiox SP Pump2007-11-30
Dina Justice [TERUMO CORP.]
Capiox SP Pump2007-11-30
Dina Justice [TERUMO CORP.]
Radifocus Guide Wire for laparoscopic use2007-11-30
Dina Justice [TERUMO CORP.]
Radifocus Guide Wire for laparoscopic use2007-11-30
Dina Justice [TERUMO CORP.]
Glidewire2007-11-30
Dina Justice [TERUMO CORP.]
Glidewire2007-11-30
Dina Justice [TERUMO CORP.]
and Tapered Glidewire Gold2007-11-30
Dina Justice [TERUMO CORP.]
and Tapered Glidewire Gold2007-11-30
Dina Justice [TERUMO CORP.]
Radifocus Guide Wire2007-11-30
Dina Justice [TERUMO CORP.]
Radifocus Guide Wire2007-11-30
Dina Justice [TERUMO CORP.]
Guide Wire M2007-11-30
Dina Justice [TERUMO CORP.]
Guide Wire M2007-11-30
Dina Justice [TERUMO CORP.]
Radifocus Guide Wire M2007-11-30
Dina Justice [TERUMO CORP.]
Radifocus Guide Wire M2007-11-30
Dina Justice [TERUMO CORP.]
Glidewire2007-11-30
Dina Justice [TERUMO CORP.]
Glidewire2007-11-30
Dina Justice [TERUMO CORP.]
Radifocus Glidecath Hydrophilic Coated Catheter2007-11-30
Dina Justice [TERUMO CORP.]
Radifocus Glidecath Hydrophilic Coated Catheter2007-11-30
Dina Justice [TERUMO CORP.]
Glidewire Gold Neuro2007-11-30
Dina Justice [TERUMO CORP.]
Glidewire Gold Neuro2007-11-30
Dina Justice [TERUMO CORP.]
CAPIOX Bubble Trap2007-11-30
Dina Justice [TERUMO CORP.]
CAPIOX Bubble Trap2007-11-30
Dina Justice [TERUMO CORP.]
Radifocus Torque Device2007-11-30
Dina Justice [TERUMO CORP.]
Radifocus Torque Device2007-11-30
Dina Justice [TERUMO CORP.]
Radifocus Glidewire2007-11-30
Dina Justice [TERUMO CORP.]
Radifocus Glidewire2007-11-30
Dina Justice [TERUMO CORP.]
Glidewire Gold2007-11-30
Dina Justice [TERUMO CORP.]
Glidewire Gold2007-11-30
Dina Justice [TERUMO CORP.]
Glidewire GT2007-11-30
Dina Justice [TERUMO CORP.]
Glidewire GT2007-11-30
Dina Justice [TERUMO CORP.]
Terumo Hollow Fiber Oxygenator Circuit2007-11-30
Dina Justice [TERUMO CORP.]
Terumo Hollow Fiber Oxygenator Circuit2007-11-30
Dina Justice [TERUMO CORP.]
Runthrough NS PTCA Guide Wire2007-11-30
Dina Justice [TERUMO CORP.]
Runthrough NS PTCA Guide Wire2007-11-30
Dina Justice [TERUMO CORP.]
Radifocus Glidewire Advantage2007-11-30
Dina Justice [TERUMO CORP.]
Radifocus Glidewire Advantage2007-11-30
Dina Justice [TERUMO CORP.]
CAPIOX? AF125X Arterial Filter2007-11-30
Dina Justice [TERUMO CORP.]
CAPIOX? AF125X Arterial Filter2007-11-30
Dina Justice [TERUMO CORP.]
Reservoir2007-11-30
Dina Justice [TERUMO CORP.]
Reservoir2007-11-30
Dina Justice [TERUMO CORP.]
CAPIOX? RX15 Hollow Fiber Oxygenator w/without Hardshell2007-11-30
Dina Justice [TERUMO CORP.]
CAPIOX? RX15 Hollow Fiber Oxygenator w/without Hardshell2007-11-30
Dina Justice [TERUMO CORP.]
Reservoir2007-11-30
Dina Justice [TERUMO CORP.]
Reservoir2007-11-30
Dina Justice [TERUMO CORP.]
CAPIOX? RX25 Hollow Fiber Oxygenator with/without Hardshell2007-11-30
Dina Justice [TERUMO CORP.]
CAPIOX? RX25 Hollow Fiber Oxygenator with/without Hardshell2007-11-30
Dina Justice [TERUMO CORP.]
Progreat2007-11-30
Dina Justice [TERUMO CORP.]
Progreat2007-11-30
Dina Justice [TERUMO CORP.]
Progreat Coaxial Microcatheter System2007-11-30
Dina Justice [TERUMO CORP.]
Progreat Coaxial Microcatheter System2007-11-30
Dina Justice [TERUMO CORP.]
CAPIOX? Cardiotomy Reservoir2007-11-30
Dina Justice [TERUMO CORP.]
CAPIOX? Cardiotomy Reservoir2007-11-30
Dina Justice [TERUMO CORP.]
Progreat2007-11-30
Dina Justice [TERUMO CORP.]
Progreat2007-11-30
Dina Justice [TERUMO CORP.]
Progreat Coaxial Microcatheter System2007-11-30
Dina Justice [TERUMO CORP.]
Progreat Coaxial Microcatheter System2007-11-30
Dina Justice [TERUMO CORP.]
Reservoir2007-11-30
Dina Justice [TERUMO CORP.]
Reservoir2007-11-30
Dina Justice [TERUMO CORP.]
CAPIOX? RX05 Hollow Fiber Oxygenator with/without Hardshell2007-11-30
Dina Justice [TERUMO CORP.]
CAPIOX? RX05 Hollow Fiber Oxygenator with/without Hardshell2007-11-30
Dina Justice [TERUMO CORP.]
Surflash IV Catheter2007-11-29
Dina Justice [TERUMO CORP.]
Surflash IV Catheter2007-11-29
Dina Justice [TERUMO CORP.]
Surflash I.V. Catheter2007-11-29
Dina Justice [TERUMO CORP.]
Surflash I.V. Catheter2007-11-29
Dina Justice [TERUMO CORP.]
Venoject Luer Adaptor2007-11-29
Dina Justice [TERUMO CORP.]
Venoject Luer Adaptor2007-11-29
Dina Justice [TERUMO CORP.]
Venoject Luer Adapter2007-11-29
Dina Justice [TERUMO CORP.]
Venoject Luer Adapter2007-11-29
Dina Justice [TERUMO CORP.]
CAPIOX Luer Thermistor2007-11-29
Dina Justice [TERUMO CORP.]
CAPIOX Luer Thermistor2007-11-29
Dina Justice [TERUMO CORP.]
CAPIOX Luer Thermistor Wire Red Cable (ME Center)2007-11-29
Dina Justice [TERUMO CORP.]
CAPIOX Luer Thermistor Wire Red Cable (ME Center)2007-11-29
Dina Justice [TERUMO CORP.]
CAPIOX Luer Thermistor Wire Blue Cable (ME Center)2007-11-29
Dina Justice [TERUMO CORP.]
CAPIOX Luer Thermistor Wire Blue Cable (ME Center)2007-11-29
Dina Justice [TERUMO CORP.]
Surflo Winged Infusion Set2007-11-29
Dina Justice [TERUMO CORP.]
Surflo Winged Infusion Set2007-11-29
Dina Justice [TERUMO CORP.]
Terumo Sampling Site Coupler2007-11-29
Dina Justice [TERUMO CORP.]
Terumo Sampling Site Coupler2007-11-29
Dina Justice [TERUMO CORP.]
Tubing Clip2007-11-29
Dina Justice [TERUMO CORP.]
Tubing Clip2007-11-29
Dina Justice [TERUMO CORP.]
Teruflex Dry Collection Bag2007-11-29
Dina Justice [TERUMO CORP.]
Teruflex Dry Collection Bag2007-11-29
Dina Justice [TERUMO CORP.]
Slide Clamp2007-11-29
Dina Justice [TERUMO CORP.]
Slide Clamp2007-11-29
Dina Justice [TERUMO CORP.]
Teruflex Terumo Transfer Bags2007-11-29
Dina Justice [TERUMO CORP.]
Teruflex Terumo Transfer Bags2007-11-29
Dina Justice [TERUMO CORP.]
Terumo Teruflex Separation Stand2007-11-29
Dina Justice [TERUMO CORP.]
Terumo Teruflex Separation Stand2007-11-29
Dina Justice [TERUMO CORP.]
Terumo Hand-Sealer2006-04-11
Dina Justice [TERUMO CORP.]
Terumo Hand-Sealer2006-04-11
Dina Justice [TERUMO CORP.]
Holder for CAPIOX? Sampling Manifold2002-02-12
Dina Justice [TERUMO CORP.]
Holder for CAPIOX? Sampling Manifold2002-02-12
Dina Justice [TERUMO CORP.]
Holder for CAPIOX? SX18R2002-02-12
Dina Justice [TERUMO CORP.]
Holder for CAPIOX? SX18R2002-02-12
Dina Justice [TERUMO CORP.]
Holder for CAPIOX? SX182002-02-12
Dina Justice [TERUMO CORP.]
Holder for CAPIOX? SX182002-02-12
Dina Justice [TERUMO CORP.]
Holder for CAPIOX? RX/FX 15 & 25 Oxygenators2002-02-12
Dina Justice [TERUMO CORP.]
Holder for CAPIOX? RX/FX 15 & 25 Oxygenators2002-02-12
Dina Justice [TERUMO CORP.]
Holder for CAPIOX? Oxygenator2002-02-12
Dina Justice [TERUMO CORP.]
Holder for CAPIOX? Oxygenator2002-02-12
Dina Justice [TERUMO CORP.]
Holder for CAPIOX? Oxygenator with Reservoir2002-02-12
Dina Justice [TERUMO CORP.]
Holder for CAPIOX? Oxygenator with Reservoir2002-02-12
Dina Justice [TERUMO CORP.]
Holder for CAPIOX? Filters and Bubble Traps2002-02-12
Dina Justice [TERUMO CORP.]
Holder for CAPIOX? Filters and Bubble Traps2002-02-12
Dina Justice [TERUMO CORP.]
CAPIOX? FX Holder2002-02-12
Dina Justice [TERUMO CORP.]
CAPIOX? FX Holder2002-02-12
Dina Justice [TERUMO CORP.]
CAPIOX? Cardiotomy Reservoir Holder2002-02-12
Dina Justice [TERUMO CORP.]
CAPIOX? Cardiotomy Reservoir Holder2002-02-12
Dina Justice [TERUMO CORP.]
CAPIOX? CR Holder2002-02-12
Dina Justice [TERUMO CORP.]
CAPIOX? CR Holder2002-02-12
Dina Justice [TERUMO CORP.]
Terumo Sterile Tubing Welder (TSCD)1996-08-21
Dina Justice [TERUMO CORP.]
Terumo Sterile Tubing Welder (TSCD)1996-08-21
Dina Justice [TERUMO CORP.]
TSCD Wafers1996-08-21
Dina Justice [TERUMO CORP.]
TSCD Wafers1996-08-21
Dina Justice [TERUMO CORP.]
Terumo Blood Collection Scale1996-08-20
Dina Justice [TERUMO CORP.]
Terumo Blood Collection Scale1996-08-20
Dina Justice [TERUMO CORP.]
Radifocus Angiographic Catheter1996-08-19
Dina Justice [TERUMO CORP.]
Radifocus Angiographic Catheter1996-08-19

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