FDA.report

TERUMO MEDICAL CORP.

Matched from indexed company URL: TERUMO CORPORATION

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
11188801118880TERUMO MEDICAL CORP.1Y2026-01-01950 ELKTON BLVD. ELKTON MD US 21921
11248413000204839TERUMO CARDIOVASCULAR SYSTEMS CORPORATION1Y2026-01-01125 BLUE BALL RD ELKTON MD US 21921
17220281000117351Terumo BCT, Inc..1Y2026-01-0110811 W COLLINS AVE Lakewood CO US 80215
17244743003094851Terumo BCT STERILIZATION SERVICES, Inc.1N2026-01-0111308 W Collins Ave LAKEWOOD CO US 80215
18281001828100TERUMO CARDIOVASCULAR SYSTEMS CORPORATION1N2026-01-016200 Jackson Road ANN ARBOR MI US 48103
22434412243441TERUMO MEDICAL CORP.1N2026-01-01265 Davidson Ave Suite 320 Somerset NJ US 08873
96818393002808337Terumo Corporation Fujinomiya Factory1N2026-01-01818, MISONODAIRA FUJINOMIYA-SHI Shizuoka JP 418-0004
30037060123003706012TERUMO LATIN AMERICA CORPORATION1Y2026-01-01121 Alhambra Plaza Suite 1120 Coral Gables FL US 33134
30039029553003902955TERUMO (PHILIPPINES) CORPORATION1N2026-01-01No. 124 EAST MAIN AVE. LAGUNA TECHNOPARK BINAN Laguna PH 4024
30041020313004102031TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD.1N2026-01-01M4-9-5,HANGZHOU ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE HANGZHOU Zhejiang CN 310018
30052288723005228872TERUMO CARDIOVASCULAR SYSTEMS THI PLANT1N2026-01-016190 JACKSON ROAD Ann Arbor MI US 48103
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
30133949703013394970Terumo Puerto Rico LLC1N2026-01-01Innovacion Street Lot 21 Caguas West Industrial Park Caguas PR US 00725
30136117633013611763Terumo Yamaguchi Corporation1N2026-01-013-22 Sayama-Aza-Murayama, Yamaguchi-shi JP 754-0894
30165218333016521833TERUMO VIETNAM CO., LTD1N2026-01-01Lot 44A-44B-44C, Quang Minh Industrial Zone, Chi Dong Town, Me L Hanoi City Ha Noi VN 100000
30175812843017581284TERUMO BCT, INC.- Littleton1N2026-01-013525 Carder Ct Highlands Ranch CO US 80129
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
12121221000149028TERUMO CARDIOVASCULAR SYSTEMS CORPORATION1N2020-04-2528 Howe St ASHLAND MA US 01721
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 GUDIDProductPhoneEmail
04987350740601GLIDEWIRE GT-R - Glidewire GT-R Guide Wire+1(800)283-7866tmccustomer.admin@terumomedical.com
04987350740625GLIDEWIRE GT-R - Glidewire GT-R Guide Wire+1(800)283-7866tmccustomer.admin@terumomedical.com
04987350740649GLIDEWIRE GT-R - Glidewire GT-R Guide Wire+1(800)283-7866tmccustomer.admin@terumomedical.com
04987350740687GLIDEWIRE GT-R - Glidewire GT-R Guide Wire+1(800)283-7866tmccustomer.admin@terumomedical.com
04987350740700GLIDEWIRE GT-R - Glidewire GT-R Guide Wire+1(800)283-7866tmccustomer.admin@terumomedical.com
04987350745422GLIDEWIRE GT-R - Glidewire GT-R Guide Wire+1(800)283-7866tmccustomer.admin@terumomedical.com
54987350740668GLIDEWIRE GT-R - Glidewire GT-R Guide Wire+1(800)283-7866tmccustomer.admin@terumomedical.com
54987350740699GLIDEWIRE GT-R - Glidewire GT-R Guide Wire+1(800)283-7866tmccustomer.admin@terumomedical.com

Registered Device Listings

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
39951020133362K993772X-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
125551567601058K991430SMARTPREP CENTRIFUGE SYSTEMJQC1999-05-28
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
39951592440478K9729623M CDI BLOOD PARAMETER MONITORING SYSTEM 500DRY1997-11-06
1249251952174702K962667CAPIOX SX25 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIRDTZ1996-10-07
39951638551855K961000CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIRDTZ1996-10-02
1249252070184441K961000CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIRDTZ1996-10-02
1363621190534002K960916SAMS 8000 CARDIOPLEGIA MONITORDSJ1996-06-04
1249251557772803K955801RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLDDQX1996-02-02
129381938955840K954234RADIFOCUS INTRODUCER II KITDYB1995-11-27
1249251938955840K954234RADIFOCUS INTRODUCER II KITDYB1995-11-27
1363621784110343K953904SARNS 9000 UNIVERSAL ROLLER PUMPDWB1996-04-19
1363621684708248K953901SARNS 800 ROLLER PUMPDWB1996-04-19
1363621074749498K9507393M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEMDWA1995-11-17
1249251620264270K943917CAPIOX ARTERIAL FILTERDTM1995-07-25
1363621841199121K940651SARNS ULTRASONIC AIR SENSORKRL1994-05-24
1363621512313268K935391SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACKGFA1994-02-24
125571764255057K933084CHECK VALVE (FITTING)DTL1994-03-23
39951304262079K923982OLYMPUS OES LAPAROSCOPY SYSTEMGCJ1993-03-15
1249252055170580K923607RADIFOCUS GUIDE WIRE MKOD1992-10-02
39951209334972K922992CONDUCER CARDIOPLEGIA SET SITH MP4DWF1992-09-18
1249251884388658K915414TERUMO ANGIOGTAPHIC CATHETERDQO1992-02-04
39951952549695K915363SARNS 7850 CENTRIFUGAL PUMP (MODIFIED)KFM1993-07-28
39951412237249K915265CDI(TM) H/S CUVETTE, MODIFICATIONDRY1992-01-15
1363622070393591K915183SARNS 8000 MODULAR PERFUSION SYSTEMDTQ1992-07-08
1249251942554467K9130740.016 GUIDE WIRE FOR NEUROLOGICAL ENDOSCOPEDQX1991-11-05
1249251317569021K911632CAPIOX(R) BUBBLE TRAPKRL1991-07-09
1249251828459438K910969TORQUE DEVICE FOR A GUIDE WIREDQX1991-05-16
1363621294056715K905686SARNS TEMPERATURE PROBE AND CONNECTORDWE1991-02-25
1363621872795141K902654CDI (TM) SYSTEM 100 MONITORING SYSTEMDTY1990-11-05
1363621338225006K902198SARNS DELPHIN BASE ADAPTER WITH BATTERYKFM1990-07-13
1363621474595259K900815SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVELDTW1990-05-09
39951312259685K900640MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDUDTR1990-04-20
129381079271861K900309VENOJECT II BLOOD COLLECTION TUBESJKA1990-03-15
1249251079271861K900309VENOJECT II BLOOD COLLECTION TUBESJKA1990-03-15
125551767730244K900105COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTICLKN1991-03-22
39952056644843K897039SARNS MINIPRIME CARDIOPLEGIA SET W/CONDUCER(TM)DTR1990-03-16
125551585209618K893962COBE 2991 SUPPLEMENTARY DISPOSABLE SETSLKN1989-10-18
129381521344620K891146TERUMO SURFLO(R) INJECTION PLUGFPA1989-06-23
1363621306132950K883603SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)DWC1988-11-03
1363621257512415K882758CENTRIFUGAL PUMP SYSTEM LX/DX VERSIONKFM1988-10-13
1363621381061950K871131SARNS 9000 HEART-LUNG CONSOLEDTQ1987-05-21
129381337921803K863138TERUMO RADIFOCUS GUIDE WIREDQX1986-11-20
1249251337921803K863138TERUMO RADIFOCUS GUIDE WIREDQX1986-11-20
125551415199556K854446TERUMO TERUFUSION BLOOD & Y-TYPE ADMIN. SETFPA1986-01-09
1249251472311754K852087CAPIOX LUER DESIGN THERMISTORS & CAPIOX CONNECTORSFLL1985-06-27
129381999165661K851834MANAN GWI GUIDE WIRE INTRODUCERDWS1985-07-11
1363621965117643K841402TEMPERATURE CONTROL & MONITORDWC1984-06-11
129381974988898K833475CAPIJECT SYS CAPILLARY BLOOD COLLECTJKA1983-12-08
1249251974988898K833475CAPIJECT SYS CAPILLARY BLOOD COLLECTJKA1983-12-08
125551389045681K831004AUTOMATED 8400 BLOOD CELL SEPARATORLKN1983-09-12
39951629624892K823451CLEAR CARDIOPLEJIA DELIVERY SYSTEMDTR1983-01-14
125572056057475K823331PC-204 TUNNELORFKX1983-01-26
125571241734021K823330DIALATORS PC-203 & 202FKX1983-01-26
125571347886894K823303QUILL CATHETER GUIDEFKX1983-01-26
129381635541442K822083U-100 INSULIN SYRINGEFMF1982-08-16
1249251635541442K822083U-100 INSULIN SYRINGEFMF1982-08-16
1363621841101347K820638PEDIATRIC SUCKERKDC1982-04-09
39951829944899K820297WM. HARVEY OVERPRESSURE SAFETY VALVEDTL1982-03-12
1249251575102394K812659TERUMO HOLLOW OXYGENATOR CIRCUITDTM1981-12-14
1363621544180820K810416SARNS MINI-SUCKERGCY1981-03-05
39951870134000K810079SARNS INTEGRATED CARDIOPLEGIA DELIV. SYSKRI1981-01-30
125551913810067K801082GAMBRO HEMOFREEZE-BAGKSR1980-10-31
125551249052046K790105TERUMO IMUGARDGKT1979-05-24
1249251469938633K771204SURFLO WINGED INFUSION SETFPA1977-07-14
125551996515740K760856BLOOD CELL PROCESSOR MODEL 2 IBM 2991GKT1977-01-10
1220971676032664K252402Midline CatheterPND2025-12-18
1220971572721126K252398SURFLO Hybria Closed System Safety IV CatheterFOZ2025-12-17
743071906486859K250684OPUSWAVE Dual Sensor Imaging SystemNQQ2025-07-02
1249251483252360K240859Glidewire GT-RDQX2024-08-21
1363621230032799K234065CDI OneView Monitoring SystemDRY2024-04-25
129381866982757K231044R2P NavicrossDQY2023-07-27
1249251866982757K231044R2P NavicrossDQY2023-07-27
1363621158301107K221895Terumo Advanced Perfusion System 1DTQ2023-04-18
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
39951805100120K200091Capiox iCP Centrifugal PumpKFM2021-11-18
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

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
DYB462020-01-06
DTZ292018-06-22
FMF202014-10-17
FMI172015-10-16
DQX162024-08-21
DTQ162023-04-18
HCG152016-08-31
LKN142019-02-05
DRY122024-04-25
DQY122023-07-27
FPA122023-06-23
KFM112021-11-18
KRD102017-03-03
DTM102012-05-08
DQO92021-12-21
DWB82016-11-17
DTN82015-12-02
DTL82010-05-19
GCJ62010-05-12
FOZ52025-12-17
DWF52015-05-05
DWC52007-11-21
JKA51998-11-30
GEI42016-04-21
DWE32015-05-01
JQC32010-12-06
MGB31996-09-30
KRL31994-05-24
DTR31990-04-20
FKX31983-01-26
DXC22021-12-20
OCY22015-09-17
KRA22008-09-26
JCT22007-09-19
MEG22005-09-27
DPW22003-05-14
DSJ21996-06-04
DWA21995-11-17
GFA21994-02-24
DTY21990-11-05

NDC

ACD

Terumo BCT, Ltd.

Citric Acid Monohydrate, Dextrose Monohydrate, and Trisodium Citrate Dihydrate

ACD

Terumo BCT, Ltd.

Citric Acid Monohydrate, Dextrose Monohydrate, and Trisodium Citrate Dihydrate

Additive Formula 3

Terumo BCT, Ltd

Dextrose Monohydrate, TRISODIUM CITRATE DIHYDRATE, Sodium Chloride, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, Citric Acid Monohydrate, and Adenine

Additive Formula 3

Terumo BCT, Ltd

Dextrose Monohydrate, TRISODIUM CITRATE DIHYDRATE, Sodium Chloride, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, Citric Acid Monohydrate, and Adenine

ACD

Terumo BCT Ltd

Dextrose Monohydrate, Sodium Citrate, and Citric Acid Monohydrate

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

200 records. Showing 1-40. Next

GUDID

200 records. Showing 1-40. Next