Terumo Medical Corp
Terumo Medical Corp appears in FDA public data with 20 recalls, 143 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-2337-2018, Class II) was initiated on April 9, 2018. Its most recent 510(k) clearance was granted on October 3, 2011.
Summary
- Total Recalls
- 20
- 510(k) Clearances
- 143
- Inspections
- 1
- Compliance Actions
- 0
Known Names
terumo medical, terumo medical corporation
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2337-2018 | Class II | Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135 | April 9, 2018 |
| Z-0229-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*RS | June 7, 2017 |
| Z-0217-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.021), REF/Product Code | June 7, 2017 |
| Z-0220-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021), REF/Product Code | June 7, 2017 |
| Z-0218-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0.021), REF/Product Code | June 7, 2017 |
| Z-0227-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 16CM (0.021), REF/Product Code RM*RS | June 7, 2017 |
| Z-0230-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021), REF/Product Code RM*RS | June 7, 2017 |
| Z-0226-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS | June 7, 2017 |
| Z-0219-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.025), REF/Product Code | June 7, 2017 |
| Z-0216-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*CS | June 7, 2017 |
| Z-0221-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0.021), REF/Product Code | June 7, 2017 |
| Z-0225-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025), REF/Product Code RM*RS | June 7, 2017 |
| Z-0214-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*CS | June 7, 2017 |
| Z-0215-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*CS | June 7, 2017 |
| Z-0222-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.025), REF/Product Code | June 7, 2017 |
| Z-0224-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 16CM (0.021), REF/Product Code RM*RS | June 7, 2017 |
| Z-0223-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*RS | June 7, 2017 |
| Z-0228-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025), REF/Product Code RM*RS | June 7, 2017 |
| Z-0669-2017 | Class II | MISAGO RX Self Expanding Peripheral Stem | August 4, 2016 |
| Z-0551-2016 | Class II | Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S2 | November 23, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K111606 | PINNACLE PRECISION ACCESS SYSTEM | October 3, 2011 |
| K111556 | GLIDECROSS SUPPORT CATHETER | July 29, 2011 |
| K110540 | TERUMO SUPPORT CATHETER | May 13, 2011 |
| K102008 | GLIDESHEATH | July 21, 2010 |
| K091329 | PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH | May 29, 2009 |
| K082997 | TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER | April 15, 2009 |
| K090040 | RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) | February 6, 2009 |
| K082847 | PINNACLE ROII INTRODUCER SHEATH | October 29, 2008 |
| K082519 | FINECROSS MG CORONARY MICRO-GUIDE CATHETER | September 26, 2008 |
| K082736 | RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER | September 24, 2008 |
| K082644 | GLIDESHEATH | September 18, 2008 |
| K082362 | SURSHIELD SAFETY I.V. CATHETER | September 17, 2008 |
| K081045 | DESTINATION RENAL GUIDING SHEATH | May 28, 2008 |
| K081046 | PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH | May 21, 2008 |
| K080563 | RUNTHROUGH NS EXTENSION WIRE | March 20, 2008 |
| K080415 | DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH | March 7, 2008 |
| K071630 | TERUMO 31G THINPRO INSULIN SYRINGE | July 11, 2007 |
| K063695 | RUNTHROUGH NS | April 27, 2007 |
| K070423 | TR BAND | March 28, 2007 |
| K063372 | RADIFOCUS GLIDEWIRE ADVANTAGE | January 19, 2007 |