FDA.reportPublic FDA data

TERUMO MEDICAL CORP.

Matched from indexed company URL: Terumo Medical Corp.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
11188801118880TERUMO MEDICAL CORP.1Y2026-01-01950 ELKTON BLVD. ELKTON MD US 21921
22434412243441TERUMO MEDICAL CORP.1N2026-01-01265 Davidson Ave Suite 320 Somerset NJ US 08873
30041020313004102031TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD.1N2026-01-01M4-9-5,HANGZHOU ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE HANGZHOU Zhejiang CN 310018
30061191443006119144TERUMO MEDICAL CORP.1Y2026-01-018655 COMMERCE DR., SUITE 105 STATE LINE BUSINESS PARK SOUTHAVEN MS US 38671
30083077053008307705Terumo Medical Canada, Inc.1N2026-01-0110911 Keele Street Units 2-4 Vaughan Ontario CA L6A 5A6
30235175873023517587Terumo Medical Corp.1Y2026-01-018250 Industrial Blvd Breinigsville PA US 18031
30276860823027686082Terumo Medical Corp.1Y2026-01-018590 West Buckeye Road Suite 101 Tolleson AZ US 85353
20809852080985TERUMO MEDICAL CORP.1Y2020-04-254550 W. Van Buren Street Suite B-103 PHOENIX AZ US 85043

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00389701006178DESTINATION - DESTINATION Renal Guiding Sheath+1(800)283-7866tmccustomer.admin@terumomedical.com
00389701006208DESTINATION - DESTINATION Renal Guiding Sheath+1(800)283-7866tmccustomer.admin@terumomedical.com
00389701007830DESTINATION - DESTINATION Carotid Guiding Sheath+1(800)283-7866tmccustomer.admin@terumomedical.com
00389701007847DESTINATION - DESTINATION Carotid Guiding Sheath+1(800)283-7866tmccustomer.admin@terumomedical.com
00389701007854DESTINATION - DESTINATION Carotid Guiding Sheath+1(800)283-7866tmccustomer.admin@terumomedical.com
00389701007861DESTINATION - DESTINATION Carotid Guiding Sheath+1(800)283-7866tmccustomer.admin@terumomedical.com
00389701007878DESTINATION - DESTINATION Carotid Guiding Sheath+1(800)283-7866tmccustomer.admin@terumomedical.com
00389701009391PINNACLE - PINNACLE R/O II Introducer Sheath with Radiopaque Marker+1(800)283-7866tmccustomer.admin@terumomedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
129381532508410P930038Angio Seal Vascular Closure DeviceMGB1996-09-30
1224711532508410P930038Angio Seal Vascular Closure DeviceMGB1996-09-30
1249251532508410P930038Angio Seal Vascular Closure DeviceMGB1996-09-30
1249251560845907P200045RelayPro Thoracic Stent-Graft SystemMIH2021-08-05
1249251905552753P190015TREO® Abdominal Stent-Graft SystemMIH2020-05-04
1249251527763770P180027Flow Re-Direction Endoluminal Device (FRED®) SystemOUT2019-12-16
1249251947861739P170032Woven EndoBridge (WEB) Aneurysm Embolization SystemOPR2018-12-31
1249251998233270P170013Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.QCA2018-05-30
1249251010277791K993772X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIRDTZ2000-06-05
129382022678997K992802TERUMO U-100 INSULIN SYRINGEFMF1999-09-09
1249252022678997K992802TERUMO U-100 INSULIN SYRINGEFMF1999-09-09
1249251172482564K992051RADIFOCUS OPTITORQUEDQO1999-08-10
1249251593201976K991406TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETERFOZ1999-06-16
129381922095630K990705MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SETDYB1999-06-28
1249251799907172K984576K-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
1249251173367066K983490TERUMO VENOJECT,LUER ADAPTERJKA1998-11-30
129381470360105K980796TERUMO ALLERGY SYRINGEFMF1998-04-02
1249251192639990K973516CAPIOX HEMOCONCENTRATORKDI1998-01-30
1249251952174702K962667CAPIOX SX25 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIRDTZ1996-10-07
1249252070184441K961000CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIRDTZ1996-10-02
1249251557772803K955801RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLDDQX1996-02-02
129381938955840K954234RADIFOCUS INTRODUCER II KITDYB1995-11-27
1249251938955840K954234RADIFOCUS INTRODUCER II KITDYB1995-11-27
1249251620264270K943917CAPIOX ARTERIAL FILTERDTM1995-07-25
1249252055170580K923607RADIFOCUS GUIDE WIRE MKOD1992-10-02
1249251884388658K915414TERUMO ANGIOGTAPHIC CATHETERDQO1992-02-04
1249251942554467K9130740.016 GUIDE WIRE FOR NEUROLOGICAL ENDOSCOPEDQX1991-11-05
1249251317569021K911632CAPIOX(R) BUBBLE TRAPKRL1991-07-09
1249251828459438K910969TORQUE DEVICE FOR A GUIDE WIREDQX1991-05-16
129381079271861K900309VENOJECT II BLOOD COLLECTION TUBESJKA1990-03-15
1249251079271861K900309VENOJECT II BLOOD COLLECTION TUBESJKA1990-03-15
129381521344620K891146TERUMO SURFLO(R) INJECTION PLUGFPA1989-06-23
129381337921803K863138TERUMO RADIFOCUS GUIDE WIREDQX1986-11-20
1249251337921803K863138TERUMO RADIFOCUS GUIDE WIREDQX1986-11-20
1249251472311754K852087CAPIOX LUER DESIGN THERMISTORS & CAPIOX CONNECTORSFLL1985-06-27
129381999165661K851834MANAN GWI GUIDE WIRE INTRODUCERDWS1985-07-11
129381974988898K833475CAPIJECT SYS CAPILLARY BLOOD COLLECTJKA1983-12-08
1249251974988898K833475CAPIJECT SYS CAPILLARY BLOOD COLLECTJKA1983-12-08
129381635541442K822083U-100 INSULIN SYRINGEFMF1982-08-16
1249251635541442K822083U-100 INSULIN SYRINGEFMF1982-08-16
1249251575102394K812659TERUMO HOLLOW OXYGENATOR CIRCUITDTM1981-12-14
1249251469938633K771204SURFLO WINGED INFUSION SETFPA1977-07-14
1220971676032664K252402Midline CatheterPND2025-12-18
1220971572721126K252398SURFLO Hybria Closed System Safety IV CatheterFOZ2025-12-17
1249251483252360K240859Glidewire GT-RDQX2024-08-21
129381866982757K231044R2P NavicrossDQY2023-07-27
1249251866982757K231044R2P NavicrossDQY2023-07-27
1220971002120272K221411Surflo Winged Infusion SetFPA2023-06-23
1249251166345422K221411Surflo Winged Infusion SetFPA2023-06-23
1220971395220110K220934RADIFOCUS Torque DeviceMOF2022-06-29
129381878742899K213531TR BAND Radial Compression DeviceDXC2021-12-20
1249251372315966K211078Progreat LambdaDQO2021-12-21
1249251395443375K203521FineCross M3DQY2021-03-03
129381827325854K193160Glidesheath Slender Tibial Pedal KitDYB2019-12-03
1249251827325854K193160Glidesheath Slender Tibial Pedal KitDYB2019-12-03
129381809472855K193125R2P Destination Slender Guiding SheathDYB2020-01-06
1249251809472855K193125R2P Destination Slender Guiding SheathDYB2020-01-06
1249251040602401K192135VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)DQY2019-12-24
1249251871792292K182829Scepter Mini Occlusion Balloon CatheterDQY2019-07-10
129381661759538K181237Glidesheath Slender Tibial Pedal KitDYB2018-08-03
1249251661759538K181237Glidesheath Slender Tibial Pedal KitDYB2018-08-03
129381942355202K173831Glidesheath SlenderDYB2018-05-08
1249251942355202K173831Glidesheath SlenderDYB2018-05-08
1249251054208485K173799NaviCross 0.018DQY2018-03-29
129381901547770K172995Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding SheathDYB2017-11-21
1249251901547770K172995Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding SheathDYB2017-11-21
129381305080642K171491R2P Destination Slender Guiding SheathDYB2017-10-05
1249251305080642K171491R2P Destination Slender Guiding SheathDYB2017-10-05
1249251816061982K170417Glidewire GTDQX2017-09-15
1249251373521573K170223ProgreatDQO2017-07-21
1249251287466419K163004Radifocus Glidewire Advantage TrackDQX2017-01-30
1249252030847581K162524AZUR CX Detachable 18 Peripheral Coil SystemKRD2017-03-03
129382000976385K162427Vado Bi-Directional Steerable SheathDYB2017-01-27
1249251101674400K161367HydroCoil Embolic System (HES)HCG2016-08-31
1249251038880259K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)HCG2016-01-22
1249251713937389K152740Radifocus GlidewireDQX2015-11-16
129381305247207K152525TR BAND Radial Compression DeviceDXC2015-11-10
1249251398457495K152362Terumo SurGuard 3 Safety Hypodermic NeedleFMI2015-10-16
129381151338646K152173GlidesheathDYB2015-12-01
1249251151338646K152173GlidesheathDYB2015-12-01
1249251944773319K151471Radifocus Glidewire Endoscopic WireOCY2015-09-17
1249251576412225K151398K-Pack II Needle - 29G x 5/16 Thin WallFMI2015-06-25
1249251960300952K151358AZUR CX Detachable 35 CoilsKRD2015-09-25
1249251440679098K150366SOFIA 6F CatheterDQY2015-03-27
1249251947360336K150263K-Pack II Needle-21G x 2FMI2015-04-01
1249251872217981K150232Radifocus Optitorque Angiographic CatheterDQO2015-10-19
1249251089577564K142449Headway 27 MicrocatheterDQY2015-03-26
1249251690919257K142183GLIDESHEATH SLENDERDYB2014-11-21
1249251700367634K133894SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD)FPA2014-03-18
1249251921130289K133867SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)FPA2014-02-05
1249251606994854K133626AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35KRD2013-12-20
1249251332139134K133280TERUMO SURFLO I.V. CATHETERFOZ2014-06-12
1249251033326854K132233K-PACK II NEEDLE - 27G X 3/4 THIN WALLFMI2013-09-06
1249251275652189K132083AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35KRD2013-10-28
1249251729546132K131948MICROPLEX COIL SYSTEM (MCS)HCG2013-10-04
1249251984849993K130577AZUR PUSHABLE 18 & 35 SYSTEMKRD2013-06-17
1249251905038066K123384AZUR CX DETACHABLE 18KRD2012-11-28
1249251285346578K122590RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGEDQX2013-03-01
1249251777808665K122316AZUR DETACHABLE 35KRD2012-08-29
1249251456715771K122249TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLEFMI2012-08-28
1249251043516336K121607TERUMO(R) NEEDLEFMI2012-11-08
1249252052491155K120630AZUR DETACHABLE 18KRD2012-03-28
1249251865304035K113457HYDROCOIL EMBOLIC SYSTEM (HES)HCG2011-12-16
1249251288712429K113422TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLEFMI2012-03-05
1249251911801227K113335HEARTRAIL III GUIDING CATHETERDQO2012-07-16
1249251081976857K112382TERUMO ASPRIATION CATHETERQEZ2011-12-14
1249251150529896K112226HYDROCOIL EMBOLIC SYSTEM (HES)HCG2011-09-29
1249251942908332K11179727 G X 1/2 K-PACK SURSHIELD NEEDLEFMI2011-09-22
129381621581733K111606PINNACLE PRECISION ACCESS SYSTEMDYB2011-10-03
1249251621581733K111606PINNACLE PRECISION ACCESS SYSTEMDYB2011-10-03
1249251854613773K111451MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XXHCG2011-09-20
1249251739417823K111307AZUR DETACHABLE 35 PLATINUM COIL SYSTEMKRD2011-06-15
1249251258654704K110850K-PACK II NEEDLE- 27G & 30G THIN WALLFMI2011-06-09
1249251711803064K110540TERUMO SUPPORT CATHETERDQY2011-05-13
1249251102675414K110527K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USEFMI2011-06-06
1249251857077418K103758MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10HCG2011-04-28
129381170895619K102008GLIDESHEATHDYB2010-07-21
1249251170895619K102008GLIDESHEATHDYB2010-07-21
1249251882406727K100454HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-VHCG2010-04-22
1249251447085957K100282TERUMO SURSHIELD- PUR SAFETY I.V. CATHETERFOZ2010-02-26

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DYB452020-01-06
DQX162024-08-21
HCG152016-08-31
FMI132015-10-16
FMF132007-07-11
DQY122023-07-27
FPA112023-06-23
KRD102017-03-03
DQO92021-12-21
DTZ92007-07-23
JKA51998-11-30
FOZ42025-12-17
DTM42005-09-12
MGB31996-09-30
DXC22021-12-20
OCY22015-09-17
KRA22008-09-26
DTN22004-03-01
PND12025-12-18
MOF12022-06-29
MIH 12021-08-05
OUT 12019-12-16
OPR12018-12-31
QCA12018-05-30
QEZ12011-12-14
MEG12005-09-27
KDI11998-01-30
KOD11992-10-02
KRL11991-07-09
DWS11985-07-11
FLL11985-06-27

PMA#

MISAGO® RX Self-expanding Peripheral Stent

2022-11-18

TERUMO MEDICAL CORPORATION950 Elkton Blvdelkton, MD 21921 PMA NumberP140002 Supplement NumberS023 Date Received10/26/2022 Decision Date11/18/2022 Product Code NIP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chan...

MISAGO® RX Self-expanding Peripheral Stent

2022-10-21

TERUMO MEDICAL CORPORATION950 Elkton Blvdelkton, MD 21921 PMA NumberP140002 Supplement NumberS022 Date Received09/21/2022 Decision Date10/21/2022 Product Code NIP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Chan...

ANGIO-SEAL VIP Vascular Closure

2022-08-26

TERUMO MEDICAL CORPORATION950 Elkton Blvd.elkton, MD 21921 PMA NumberP930038 Supplement NumberS100 Date Received07/28/2022 Decision Date08/26/2022 Product Code MGB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Cha...

115 records. Showing 1-40. Next

PMN#

TR BAND

2007-03-28

TERUMO MEDICAL CORP.

165 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next