Terumo Medical Corp

FDA Regulatory Profile

Summary

Total Recalls
20
510(k) Clearances
143
Inspections
1
Compliance Actions
0

Known Names

terumo medical, terumo medical corporation

Recent Recalls

NumberClassProductDate
Z-2337-2018Class IIAngio-Seal Evolution Vascular Closure Device, Cat. No. C610135April 9, 2018
Z-0214-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*CSJune 7, 2017
Z-0224-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 16CM (0.021), REF/Product Code RM*RSJune 7, 2017
Z-0221-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0.021), REF/Product CodeJune 7, 2017
Z-0222-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.025), REF/Product CodeJune 7, 2017
Z-0227-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 16CM (0.021), REF/Product Code RM*RSJune 7, 2017
Z-0226-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RSJune 7, 2017
Z-0219-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.025), REF/Product CodeJune 7, 2017
Z-0216-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*CSJune 7, 2017
Z-0218-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0.021), REF/Product CodeJune 7, 2017
Z-0230-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021), REF/Product Code RM*RSJune 7, 2017
Z-0225-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025), REF/Product Code RM*RSJune 7, 2017
Z-0228-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025), REF/Product Code RM*RSJune 7, 2017
Z-0217-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.021), REF/Product CodeJune 7, 2017
Z-0223-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*RSJune 7, 2017
Z-0229-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*RSJune 7, 2017
Z-0220-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021), REF/Product CodeJune 7, 2017
Z-0215-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*CSJune 7, 2017
Z-0669-2017Class IIMISAGO RX Self Expanding Peripheral StemAugust 4, 2016
Z-0551-2016Class IITerumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S2November 23, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K111606PINNACLE PRECISION ACCESS SYSTEMOctober 3, 2011
K111556GLIDECROSS SUPPORT CATHETERJuly 29, 2011
K110540TERUMO SUPPORT CATHETERMay 13, 2011
K102008GLIDESHEATHJuly 21, 2010
K091329PINNACLE DESTINATION PERIPHERAL GUIDING SHEATHMay 29, 2009
K082997TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETERApril 15, 2009
K090040RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)February 6, 2009
K082847PINNACLE ROII INTRODUCER SHEATHOctober 29, 2008
K082519FINECROSS MG CORONARY MICRO-GUIDE CATHETERSeptember 26, 2008
K082736RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETERSeptember 24, 2008
K082644GLIDESHEATHSeptember 18, 2008
K082362SURSHIELD SAFETY I.V. CATHETERSeptember 17, 2008
K081045DESTINATION RENAL GUIDING SHEATHMay 28, 2008
K081046PINNACLE DESTINATION PERIPHERAL GUIDING SHEATHMay 21, 2008
K080563RUNTHROUGH NS EXTENSION WIREMarch 20, 2008
K080415DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATHMarch 7, 2008
K071630TERUMO 31G THINPRO INSULIN SYRINGEJuly 11, 2007
K063695RUNTHROUGH NSApril 27, 2007
K070423TR BANDMarch 28, 2007
K063372RADIFOCUS GLIDEWIRE ADVANTAGEJanuary 19, 2007