Terumo Medical Corp.
Elkton, MD, US
TERUMO MEDICAL CORP. appears in FDA device records in Elkton, MD. FDA records list 157 510(k) clearances between and , 133 PMA records and 5 registered establishments. As of , FDA records show 44 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 157FDA records hold 157 510(k) clearances for Terumo Medical Corp. between 1980 and 2023. The busiest year on record is 1986, with 11. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1981 | 7 |
| 1982 | 9 |
| 1983 | 7 |
| 1984 | 5 |
| 1985 | 6 |
| 1986 | 11 |
| 1987 | 2 |
| 1988 | 3 |
| 1989 | 6 |
| 1990 | 2 |
| 1991 | 3 |
| 1992 | 4 |
| 1993 | 4 |
| 1995 | 4 |
| 1996 | 6 |
| 1997 | 5 |
| 1998 | 4 |
| 1999 | 7 |
| 2000 | 5 |
| 2001 | 8 |
| 2002 | 1 |
| 2003 | 3 |
| 2004 | 2 |
| 2005 | 4 |
| 2006 | 4 |
| 2007 | 4 |
| 2008 | 9 |
| 2009 | 3 |
| 2010 | 1 |
| 2011 | 4 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 3 |
| 2017 | 2 |
| 2018 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231044 | R2P Navicross | DQY | Substantially Equivalent | |
| K213531 | TR BAND Radial Compression Device | DXC | Substantially Equivalent | |
| K193125 | R2P Destination Slender Guiding Sheath | DYB | Substantially Equivalent | |
| K181237 | Glidesheath Slender Tibial Pedal Kit | DYB | Substantially Equivalent | |
| K173831 | Glidesheath Slender | DYB | Substantially Equivalent | |
| K172995 | Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath | DYB | Substantially Equivalent | |
| K171491 | R2P Destination Slender Guiding Sheath | DYB | Substantially Equivalent | |
| K152173 | Glidesheath | DYB | Substantially Equivalent | |
| K152525 | TR BAND Radial Compression Device | DXC | Substantially Equivalent | |
| K151471 | Radifocus Glidewire Endoscopic Wire | OCY | Substantially Equivalent | |
| K142183 | GLIDESHEATH SLENDER | DYB | Substantially Equivalent | |
| K122590 | RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE | DQX | Substantially Equivalent | |
| K122980 | GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ | DYB | Substantially Equivalent | |
| K112382 | TERUMO ASPRIATION CATHETER | QEZ | Substantially Equivalent | |
| K111606 | PINNACLE PRECISION ACCESS SYSTEM | DYB | Substantially Equivalent | |
| K111556 | GLIDECROSS SUPPORT CATHETER | DQY | Substantially Equivalent | |
| K110540 | TERUMO SUPPORT CATHETER | DQY | Substantially Equivalent | |
| K102008 | GLIDESHEATH | DYB | Substantially Equivalent | |
| K091329 | PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH | DYB | Substantially Equivalent | |
| K082997 | TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER | FOZ | Substantially Equivalent | |
| K090040 | RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) | DQO | Substantially Equivalent | |
| K082847 | PINNACLE ROII INTRODUCER SHEATH | DYB | Substantially Equivalent | |
| K082519 | FINECROSS MG CORONARY MICRO-GUIDE CATHETER | KRA | Substantially Equivalent | |
| K082736 | RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER | DQO | Substantially Equivalent | |
| K082644 | GLIDESHEATH | DYB | Substantially Equivalent | |
| K082362 | SURSHIELD SAFETY I.V. CATHETER | FOZ | Substantially Equivalent | |
| K081045 | DESTINATION RENAL GUIDING SHEATH | DYB | Substantially Equivalent | |
| K081046 | PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH | DYB | Substantially Equivalent | |
| K080563 | RUNTHROUGH NS EXTENSION WIRE | DQX | Substantially Equivalent | |
| K080415 | DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH | DYB | Substantially Equivalent | |
| K071630 | TERUMO 31G THINPRO INSULIN SYRINGE | FMF | Substantially Equivalent | |
| K063695 | RUNTHROUGH NS | DQX | Substantially Equivalent | |
| K070423 | TR BAND | DXC | Substantially Equivalent | |
| K063372 | RADIFOCUS GLIDEWIRE ADVANTAGE | DQX | Substantially Equivalent | |
| K063613 | MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE | FMF | Substantially Equivalent | |
| K062446 | MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH | DYB | Substantially Equivalent | |
| K062858 | MODIFICATION TO GLIDESHEATH | DYB | Substantially Equivalent | |
| K060666 | CAROTID ACCESS KIT | DYB | Substantially Equivalent | |
| K051865 | TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR | MEG | Substantially Equivalent | |
| K052185 | DESTINATION CAROTID GUIDING SHEATH | DYB | Substantially Equivalent | |
| K052034 | TERUMO SYRINGE WITH/WITHOUT NEEDLE | FMF | Substantially Equivalent | |
| K051601 | PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH | DYB | Substantially Equivalent | |
| K040531 | TERUMO SURGUARD2 SAFETY NEEDLE | FMI | Substantially Equivalent | |
| K033913 | PROGREAT | KRA | Substantially Equivalent | |
| K033583 | PROGREAT | DQO | Substantially Equivalent | |
| K031453 | TERUMO SURGUARD 2 SAFETY NEEDLE | FMI | Substantially Equivalent | |
| K024249 | TERUMO SURGUARD SAFETY SYRINGE | MEG | Substantially Equivalent | |
| K023271 | TERUMO SYRINGE WITH/WITHOUT NEEDLE | FMF | Substantially Equivalent | |
| K012854 | RENAL GUIDING SHEATH | DYB | Substantially Equivalent | |
| K013550 | CLIRANS E-SERIES DIALYZER | KDI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1118880 | 1118880 | TERUMO MEDICAL CORP. | 950 ELKTON BLVD., ELKTON, MD 21921 US | 2026 | |
| 2243441 | 2243441 | TERUMO MEDICAL CORP. | 265 Davidson Ave, Somerset, NJ 08873 US | 2026 | |
| 3006119144 | 3006119144 | TERUMO MEDICAL CORP. | 8655 COMMERCE DR., SUITE 105, SOUTHAVEN, MS 38671 US | 2026 | No device listings on this registration |
| 3023517587 | 3023517587 | Terumo Medical Corp. | 8250 Industrial Blvd, Breinigsville, PA 18031 US | 2026 | No device listings on this registration |
| 3027686082 | 3027686082 | Terumo Medical Corp. | 8590 West Buckeye Road, Tolleson, AZ 85353 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KOCAccessories, Blood Circuit, Hemodialysis
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- JHJAgglutination Method, Human Chorionic Gonadotropin
- CBTArterial Blood Sampling Kit
- JISCalibrator, Primary
- GBZCatheter, Cholangiography
- BSOCatheter, Conduction, Anesthetic
- KRACatheter, Continuous Flush
- DQOCatheter, Intravascular, Diagnostic
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- DQYCatheter, Percutaneous
- KODCatheter, Urological
- DXCClamp, Vascular
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- FLLContinuous Measurement Thermometer
- DTPDefoamer, Cardiopulmonary Bypass
- KRLDetector, Bubble, Cardiopulmonary Bypass
- MGBDevice, Hemostasis, Vascular
- FJIDialyzer, Capillary, Hollow Fiber
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System
- KXTEnzyme Immunoassay, Digoxin
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line
- FPBFilter, Infusion Line
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- DGCIge, Antigen, Antiserum, Control
- DWSInstruments, Surgical, Cardiovascular
- DYBIntroducer, Catheter
- GCJLaparoscope, General & Plastic Surgery
- DTWMonitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
- DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- DZMNeedle, Dental
- FIENeedle, Fistula
- FMINeedle, Hypodermic, Single Lumen
- DTZOxygenator, Cardiopulmonary Bypass
- KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- FRNPump, Infusion
- KHQRadioassay, Triiodothyronine Uptake
- CHPRadioimmunoassay, Estradiol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CFLRadioimmunoassay, Human Growth Hormone
- CEPRadioimmunoassay, Luteinizing Hormone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- DTNReservoir, Blood, Cardiopulmonary Bypass
- FPASet, Administration, Intravascular
- LBWSet, Dialysis, Single Needle (Co-Axial Flow)
- FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve
- MWSStabilizer, Heart
- FMGStopcock, I.V. Set
- MEGSyringe, Antistick
- FMFSyringe, Piston
- HGMSystem, Monitoring, Perinatal
- BTRTube, Tracheal (W/Wo Connector)
- GIMTubes, Vacuum Sample, With Anticoagulant
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
- FPKTubing, Fluid Delivery
- HRNUnit, Cryophthalmic, Ac-Powered
- DQXWire, Guide, Catheter
Recall records
Showing 25 of 44| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2930-2026 | 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. | Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire. | Class II | Open, Classified | |
| Z-1376-2019 | Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20 | There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath. | Class I | Terminated | |
| Z-1375-2019 | SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435 | There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath. | Class I | Terminated | |
| Z-1374-2019 | 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 SoloPath Balloon Expandable TransFemoral Introducer System (STFI) and the SoloPath Re-Collapsible Access System are sterile, single use devices designed for low profile, large bore vessel access. Both SoloPath products are inserted percutaneously into the femoral artery, over a guidewire, and once expanded, provide a guide for catheters and/or devices introduced into the femoral/iliac arteries. The devices are designed such that surface friction is reduced during insertion while minimizing access trauma and vessel trauma throughout the procedure. | There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath. | Class I | Terminated | |
| Z-2006-2019 | Terumo Needle, 30G x 1/2", Product Code NN3013R | There is a potential for a loss of package integrity that may compromise the sterility of the product. | Class II | Terminated | |
| Z-2005-2019 | Terumo Needle, 23G x 1", Product Code NN2325R | There is a potential for a loss of package integrity that may compromise the sterility of the product. | Class II | Terminated | |
| Z-2004-2019 | Terumo Needle, 18G x 1", Product Code NN1825R | There is a potential for a loss of package integrity that may compromise the sterility of the product. | Class II | Terminated | |
| Z-2003-2019 | Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280 | There is a potential for a loss of package integrity that may compromise the sterility of the product. | Class II | Terminated | |
| Z-2002-2019 | Terumo Sur-vet Needle, 22G x 3/4", Product Code 100279 | There is a potential for a loss of package integrity that may compromise the sterility of the product. | Class II | Terminated | |
| Z-2001-2019 | Terumo Sur-vet Needle, 25G x 5/8", Product Code 100220 | There is a potential for a loss of package integrity that may compromise the sterility of the product. | Class II | Terminated | |
| Z-2000-2019 | Terumo Sur-vet Needle, 22G x 3/4", Product Code 100215 | There is a potential for a loss of package integrity that may compromise the sterility of the product. | Class II | Terminated | |
| Z-1999-2019 | Terumo Sur-vet Needle, 22G x 1", Product Code 100211 | There is a potential for a loss of package integrity that may compromise the sterility of the product. | Class II | Terminated | |
| Z-1998-2019 | Terumo Sur-vet Needle, 20G x 1", Product Code 100204 | There is a potential for a loss of package integrity that may compromise the sterility of the product. | Class II | Terminated | |
| Z-2337-2018 | Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135 | Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Although sterile, products from these lots may not function as intended and therefore should not be used. | Class II | Terminated | |
| Z-0725-2018 | 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 devices into the human vasculature, including but not limited to the renal, carotid, and peripheral arteries. | The tucking depth feature of this catheter introducer is marginally outside the upper specification. | Class II | Terminated | |
| Z-0230-2018 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021), REF/Product Code RM*RS7F16PA, STERILE, Rx ONLY | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath. | Class II | Terminated | |
| Z-0229-2018 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*RS7F10PA, STERILE, Rx ONLY | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath. | Class II | Terminated | |
| Z-0228-2018 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025), REF/Product Code RM*RS6J10PA, STERILE, Rx ONLY | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath. | Class II | Terminated | |
| Z-0227-2018 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 16CM (0.021), REF/Product Code RM*RS6F16PA, STERILE, Rx ONLY | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath. | Class II | Terminated | |
| Z-0226-2018 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath. | Class II | Terminated | |
| Z-0225-2018 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025), REF/Product Code RM*RS5J10PA, STERILE, Rx ONLY | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath. | Class II | Terminated | |
| Z-0224-2018 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 16CM (0.021), REF/Product Code RM*RS5F16PA, STERILE, Rx ONLY | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath. | Class II | Terminated | |
| Z-0223-2018 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*RS5F10PA, STERILE, Rx ONLY | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath. | Class II | Terminated | |
| Z-0222-2018 | Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.025), REF/Product Code RM*ES6J10HAT, STERILE, Rx ONLY | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath. | Class II | Terminated | |
| Z-0221-2018 | Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0.021), REF/Product Code RM*ES6F16HAU, STERILE, Rx ONLY | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain