Company ยท US
Terumo Medical Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 2023. Name variants (Inc, Corp, punctuation) are merged.
157510(k) clearances (0 in 12 months)
44recalls (1 in 12 months)
42recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DYB | Introducer, Catheter | 56 |
| FMI | Needle, Hypodermic, Single Lumen | 14 |
| DQX | Wire, Guide, Catheter | 12 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 10 |
| FMF | Syringe, Piston | 10 |
| DQO | Catheter, Intravascular, Diagnostic | 6 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 6 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 6 |
| FPA | Set, Administration, Intravascular | 6 |
| DQY | Catheter, Percutaneous | 4 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 4 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 4 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 3 |
| DXC | Clamp, Vascular | 3 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 3 |
| MEG | Syringe, Antistick | 3 |
| FLL | Continuous Measurement Thermometer | 2 |
| FMG | Stopcock, I.V. Set | 2 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 2 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 27, 2023 | K231044 | R2P Navicross Terumo Medical Corporation | DQY |
| Dec 20, 2021 | K213531 | TR BAND Radial Compression Device Terumo Medical Corporation | DXC |
| Jan 6, 2020 | K193125 | R2P Destination Slender Guiding Sheath Terumo Medical Corporation | DYB |
| Aug 3, 2018 | K181237 | Glidesheath Slender Tibial Pedal Kit Terumo Medical Corporation | DYB |
| May 8, 2018 | K173831 | Glidesheath Slender Terumo Medical Corporation | DYB |
| Nov 21, 2017 | K172995 | Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath Terumo Medical Corporation | DYB |
| Oct 5, 2017 | K171491 | R2P Destination Slender Guiding Sheath Terumo Medical Corporation | DYB |
| Dec 1, 2015 | K152173 | Glidesheath Terumo Medical Corporation | DYB |
| Nov 10, 2015 | K152525 | TR BAND Radial Compression Device Terumo Medical Corporation | DXC |
| Sep 17, 2015 | K151471 | Radifocus Glidewire Endoscopic Wire Terumo Medical Corporation | OCY |
| Nov 21, 2014 | K142183 | GLIDESHEATH SLENDER Terumo Medical Corporation | DYB |
| Mar 1, 2013 | K122590 | RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE Terumo Medical Corporation | DQX |
| Dec 11, 2012 | K122980 | GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ Terumo Medical Corporation | DYB |
| Dec 14, 2011 | K112382 | TERUMO ASPRIATION CATHETER Terumo Medical Corporation | QEZ |
| Oct 3, 2011 | K111606 | PINNACLE PRECISION ACCESS SYSTEM Terumo Medical Corp. | DYB |
| Jul 29, 2011 | K111556 | GLIDECROSS SUPPORT CATHETER Terumo Medical Corp. | DQY |
| May 13, 2011 | K110540 | TERUMO SUPPORT CATHETER Terumo Medical Corp. | DQY |
| Jul 21, 2010 | K102008 | GLIDESHEATH Terumo Medical Corp. | DYB |
| May 29, 2009 | K091329 | PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH Terumo Medical Corp. | DYB |
| Apr 15, 2009 | K082997 | TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER Terumo Medical Corp. | FOZ |
| Feb 6, 2009 | K090040 | RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) Terumo Medical Corp. | DQO |
| Oct 29, 2008 | K082847 | PINNACLE ROII INTRODUCER SHEATH Terumo Medical Corp. | DYB |
| Sep 26, 2008 | K082519 | FINECROSS MG CORONARY MICRO-GUIDE CATHETER Terumo Medical Corp. | KRA |
| Sep 24, 2008 | K082736 | RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER Terumo Medical Corp. | DQO |
| Sep 18, 2008 | K082644 | GLIDESHEATH Terumo Medical Corp. | DYB |
| Sep 17, 2008 | K082362 | SURSHIELD SAFETY I.V. CATHETER Terumo Medical Corp. | FOZ |
| May 28, 2008 | K081045 | DESTINATION RENAL GUIDING SHEATH Terumo Medical Corp. | DYB |
| May 21, 2008 | K081046 | PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH Terumo Medical Corp. | DYB |
| Mar 20, 2008 | K080563 | RUNTHROUGH NS EXTENSION WIRE Terumo Medical Corp. | DQX |
| Mar 7, 2008 | K080415 | DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH Terumo Medical Corp. | DYB |
| Jul 11, 2007 | K071630 | TERUMO 31G THINPRO INSULIN SYRINGE Terumo Medical Corp. | FMF |
| Apr 27, 2007 | K063695 | RUNTHROUGH NS Terumo Medical Corp. | DQX |
| Mar 28, 2007 | K070423 | TR BAND Terumo Medical Corp. | DXC |
| Jan 19, 2007 | K063372 | RADIFOCUS GLIDEWIRE ADVANTAGE Terumo Medical Corp. | DQX |
| Dec 26, 2006 | K063613 | MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE Terumo Medical Corp. | FMF |
| Oct 23, 2006 | K062446 | MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH Terumo Medical Corp. | DYB |
| Oct 20, 2006 | K062858 | MODIFICATION TO GLIDESHEATH Terumo Medical Corp. | DYB |
| Jun 29, 2006 | K060666 | CAROTID ACCESS KIT Terumo Medical Corp. | DYB |
| Sep 27, 2005 | K051865 | TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR Terumo Medical Corp. | MEG |
| Sep 6, 2005 | K052185 | DESTINATION CAROTID GUIDING SHEATH Terumo Medical Corp. | DYB |
| Aug 16, 2005 | K052034 | TERUMO SYRINGE WITH/WITHOUT NEEDLE Terumo Medical Corp. | FMF |
| Aug 4, 2005 | K051601 | PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH Terumo Medical Corp. | DYB |
| Mar 23, 2004 | K040531 | TERUMO SURGUARD2 SAFETY NEEDLE Terumo Medical Corp. | FMI |
| Mar 11, 2004 | K033913 | PROGREAT Terumo Medical Corp. | KRA |
| Dec 12, 2003 | K033583 | PROGREAT Terumo Medical Corp. | DQO |
| Jul 8, 2003 | K031453 | TERUMO SURGUARD 2 SAFETY NEEDLE Terumo Medical Corp. | FMI |
| Feb 21, 2003 | K024249 | TERUMO SURGUARD SAFETY SYRINGE Terumo Medical Corp. | MEG |
| Dec 18, 2002 | K023271 | TERUMO SYRINGE WITH/WITHOUT NEEDLE Terumo Medical Corp. | FMF |
| Nov 21, 2001 | K012854 | RENAL GUIDING SHEATH Terumo Medical Corp. | DYB |
| Nov 20, 2001 | K013550 | CLIRANS E-SERIES DIALYZER Terumo Medical Corp. | KDI |
Newest 50 of 157.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 10, 2026 | Terumo Medical Corporation GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060.
The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery. Open, Classified |
DYB | K173831 |
| May 28, 2019 | Terumo Medical Corporation Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19,
PRTSOLO-20 Terminated |
DYB | K152498 |
| May 28, 2019 | Terumo Medical Corporation SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925,
SR-1935,
SR-2025,
SR-2035,
SR-2225,
SR-2235,
SR-2425,
SR-2435 Terminated |
DYB | K152498 |
| May 28, 2019 | Terumo Medical Corporation SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425,
STFI-1435,
STFI-1625,
STFI-1635,
STFI-1825,
STFI-1835,
STFI-1925,
STFI-1935,
STFI-2125,
STFI-2135
Product Usage:
The Terminated |
DYB | K100819 |
| Feb 8, 2019 | Terumo Medical Corporation Terumo Needle, 30G x 1/2", Product Code NN3013R Terminated |
FMI | K121607 |
| Feb 8, 2019 | Terumo Medical Corporation Terumo Needle, 23G x 1", Product Code NN2325R Terminated |
FMI | K121607 |
| Feb 8, 2019 | Terumo Medical Corporation Terumo Needle, 18G x 1", Product Code NN1825R Terminated |
FMI | K121607 |
| Feb 8, 2019 | Terumo Medical Corporation Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280 Terminated |
FMI | K121607 |
| Feb 8, 2019 | Terumo Medical Corporation Terumo Sur-vet Needle, 22G x 3/4", Product Code 100279 Terminated |
FMI | K121607 |
| Feb 8, 2019 | Terumo Medical Corporation Terumo Sur-vet Needle, 25G x 5/8", Product Code 100220 Terminated |
FMI | K121607 |
| Feb 8, 2019 | Terumo Medical Corporation Terumo Sur-vet Needle, 22G x 3/4", Product Code 100215 Terminated |
FMI | K121607 |
| Feb 8, 2019 | Terumo Medical Corporation Terumo Sur-vet Needle, 22G x 1", Product Code 100211 Terminated |
FMI | K121607 |
| Feb 8, 2019 | Terumo Medical Corporation Terumo Sur-vet Needle, 20G x 1", Product Code 100204 Terminated |
FMI | K121607 |
| Apr 9, 2018 | Terumo Medical Corp Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135 Terminated |
MGB | None listed |
| Sep 12, 2017 | Terumo Medical Corporation Destination Guiding Sheath catheter introducer, Catalog Number: RSR06
Product Usage:
The Destination Guiding Sheath is designed to be used for the introduction of interventional and diagnostic device Terminated |
DYB | K012584 |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021), REF/Product Code RM*RS7F16PA, STERILE, Rx ONLY Terminated |
DYB | K142183 |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*RS7F10PA, STERILE, Rx ONLY Terminated |
DYB | K142183 |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025), REF/Product Code RM*RS6J10PA, STERILE, Rx ONLY Terminated |
DYB | K142183 |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 16CM (0.021), REF/Product Code RM*RS6F16PA, STERILE, Rx ONLY Terminated |
DYB | K142183 |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY Terminated |
DYB | K142183 |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025), REF/Product Code RM*RS5J10PA, STERILE, Rx ONLY Terminated |
DYB | K142183 |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 16CM (0.021), REF/Product Code RM*RS5F16PA, STERILE, Rx ONLY Terminated |
DYB | K142183 |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*RS5F10PA, STERILE, Rx ONLY Terminated |
DYB | K142183 |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.025), REF/Product Code RM*ES6J10HAT, STERILE, Rx ONLY Terminated |
DYB | K142183 |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0.021), REF/Product Code RM*ES6F16HAU, STERILE, Rx ONLY Terminated |
DYB | K142183 |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021), REF/Product Code RM*ES6F10HAU, STERILE, Rx ONLY Terminated |
DYB | K142183 |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.025), REF/Product Code RM*ES5J10HAT, STERILE, Rx ONLY Terminated |
DYB | K142183 |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0.021), REF/Product Code RM*ES5F16HAU, STERILE, Rx ONLY Terminated |
DYB | K142183 |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.021), REF/Product Code RM*ES5F10HAU, STERILE, Rx ONLY Terminated |
DYB | K142183 |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*CS7F10NA, STERILE, Rx ONLY Terminated |
DYB | K142183 |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*CS6F10NA, STERILE, Rx ONLY Terminated |
DYB | K142183 |
| Jun 7, 2017 | Terumo Medical Corp Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*CS5F10NA, STERILE, Rx ONLY Terminated |
DYB | K142183 |
| May 4, 2017 | Terumo Medical Corporation Destination Renal Guiding Sheath
Intended for the introduction of interventional and diagnostic devices into the human vasculature. Terminated |
DYB | K012854 |
| Sep 6, 2016 | Terumo Medical Corporation PINNACLE Introducer Sheath
PINNACLE PRECISION ACCESS SYSTEM Sheath
PINNACLE TIF TIP" Introducer Sheath
PINNACLE R/O II Radiopaque Marker Introducer Sheath Terminated |
DYB | K111606 |
| Aug 4, 2016 | Terumo Medical Corp MISAGO RX Self Expanding Peripheral Stem Terminated |
NIP | None listed |
| Dec 24, 2015 | Terumo Medical Corp Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35. Terminated |
MEG | K133894 |
| Aug 5, 2015 | Terumo Medical Corporation SurFlo IV Catheter Terminated |
FOZ | K891087 |
| Jun 27, 2013 | Terumo Medical Corporation Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060.
Used to facilitate placing a catheter through the skin into a vein or artery. Terminated |
DYB | K102008 |
| Jun 27, 2013 | Terumo Medical Corporation Pinnacle Destination Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve.
Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human Terminated |
DYB | K091329 |
| Jul 20, 2011 | Terumo Medical Corporation Runthrough NS Tapered PTCA Guidewire, item code number TW*DP418FH
Product Usage The Runthrough NS guidewire is used to facilitate placement of balloon dilation catheters for Percutaneous Translumina Terminated |
DQX | K063695 |
| Jul 13, 2011 | Terumo Medical Corporation Terumo(tm) Hypodermic Needle, sterile, individually packaged into a "blister-pack" flexible plastic bottom-web thermo-formed to create a pocket, heat-sealed with paper top-web,1,000 needles per case. Terminated |
FMI | K771203 |
| Jun 6, 2011 | Terumo Medical Corporation Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot MD24, MD31, ME07, & ME14. 510(k) K012812
Guiding Sheath is used to facilitate the introduction of interven Terminated |
DYB | K012812 |
| Jun 6, 2011 | Terumo Medical Corporation Pinnacle Destination Guiding Sheath, 6 French, 45 cm, Hockey Stick Tip, Tuohy-Borst Valve, Lot ME07, 510 (K) K012854
Guiding Sheath is used to facilitate the introduction of interventional and diagno Terminated |
DYB | K012854 |
| Jun 6, 2011 | Terumo Medical Corporation Pinnacle Destination Guiding Sheath, 7 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lots ME07 & MF12, 510(k) K052185
Guiding Sheath is used to facilitate the introduction of interventional and dia Terminated |
DYB | K052185 |