FDA.reportPublic FDA data

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
30061191443006119144TERUMO MEDICAL CORP.1Y2026-01-018655 COMMERCE DR., SUITE 105 STATE LINE BUSINESS PARK SOUTHAVEN MS US 38671
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

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
129382022678997K992802TERUMO U-100 INSULIN SYRINGEFMF1999-09-09
129381922095630K990705MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SETDYB1999-06-28
129381470360105K980796TERUMO ALLERGY SYRINGEFMF1998-04-02
129381938955840K954234RADIFOCUS INTRODUCER II KITDYB1995-11-27
129381079271861K900309VENOJECT II BLOOD COLLECTION TUBESJKA1990-03-15
129381521344620K891146TERUMO SURFLO(R) INJECTION PLUGFPA1989-06-23
129381337921803K863138TERUMO RADIFOCUS GUIDE WIREDQX1986-11-20
129381999165661K851834MANAN GWI GUIDE WIRE INTRODUCERDWS1985-07-11
129381974988898K833475CAPIJECT SYS CAPILLARY BLOOD COLLECTJKA1983-12-08
129381635541442K822083U-100 INSULIN SYRINGEFMF1982-08-16
129381866982757K231044R2P NavicrossDQY2023-07-27
129381878742899K213531TR BAND Radial Compression DeviceDXC2021-12-20
129381827325854K193160Glidesheath Slender Tibial Pedal KitDYB2019-12-03
129381809472855K193125R2P Destination Slender Guiding SheathDYB2020-01-06
129381661759538K181237Glidesheath Slender Tibial Pedal KitDYB2018-08-03
129381942355202K173831Glidesheath SlenderDYB2018-05-08
129381901547770K172995Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding SheathDYB2017-11-21
129381305080642K171491R2P Destination Slender Guiding SheathDYB2017-10-05
129382000976385K162427Vado Bi-Directional Steerable SheathDYB2017-01-27
129381305247207K152525TR BAND Radial Compression DeviceDXC2015-11-10
129381151338646K152173GlidesheathDYB2015-12-01
129381621581733K111606PINNACLE PRECISION ACCESS SYSTEMDYB2011-10-03
129381170895619K102008GLIDESHEATHDYB2010-07-21
129381280220515K091329PINNACLE DESTINATION PERIPHERAL GUIDING SHEATHDYB2009-05-29
129382009077751K082847PINNACLE ROII INTRODUCER SHEATHDYB2008-10-29
129381995143681K081046PINNACLE DESTINATION PERIPHERAL GUIDING SHEATHDYB2008-05-21
129381870483124K081045DESTINATION RENAL GUIDING SHEATHDYB2008-05-28
129381181264026K080415DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATHDYB2008-03-07
129381996129252K071630TERUMO 31G THINPRO INSULIN SYRINGEFMF2007-07-11
129381547736550K062446MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATHDYB2006-10-23
129381322146908K052185DESTINATION CAROTID GUIDING SHEATHDYB2005-09-06
129381525538752K051601PINNACLE DESTINATION PERIPHERAL GUIDING SHEATHDYB2005-08-04
129381354692034K012854RENAL GUIDING SHEATHDYB2001-11-21
129381672803994K012812CAROTID GUIDING SHEATHDYB2001-11-14
129381448349270K011084MANDREL GUIDEWIRE ASSEMBLYDQX2001-05-10
129381971459600K003571SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGEFMF2001-02-12
129382070628250K003424PINNACLE R/O II OR RADIFOCUS INTRODUCER IIDYB2000-11-21
129381136226532K001474TERUMO U-100 INSULIN SYRINGFMF2000-06-09
129381853965894BK920040
1224711039882068
129381591626930
129381954532134

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DYB232020-01-06
FMF62007-07-11
DXC22021-12-20
DQX22001-05-10
MGB21996-09-30
JKA21990-03-15
DQY12023-07-27
FPA11989-06-23
DWS11985-07-11

PMN#

142 records. Showing 1-40. Next