Terumo Medical Corp.
Terumo Medical Corp. holds FDA 510(k) medical device clearances, first cleared 1980, most recent 2011, with 20 FDA device recalls on record.
Top product codes for Terumo Medical Corp.
FDA recalls by Terumo Medical Corp.
10 most recent of 20- Z-2337-2018 — Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135
- Z-0218-2018 — Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0.021), REF/Product Code RM*ES5F16HAU, STERILE, Rx ONLY
- Z-0227-2018 — Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 16CM (0.021), REF/Product Code RM*RS6F16PA, STERILE, Rx ONLY
- Z-0230-2018 — Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021), REF/Product Code RM*RS7F16PA, STERILE, Rx ONLY
- Z-0226-2018 — Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY
- Z-0219-2018 — Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.025), REF/Product Code RM*ES5J10HAT, STERILE, Rx ONLY
- Z-0216-2018 — Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*CS7F10NA, STERILE, Rx ONLY
- Z-0221-2018 — Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0.021), REF/Product Code RM*ES6F16HAU, STERILE, Rx ONLY
- Z-0225-2018 — Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025), REF/Product Code RM*RS5J10PA, STERILE, Rx ONLY
- Z-0222-2018 — Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.025), REF/Product Code RM*ES6J10HAT, STERILE, Rx ONLY
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Terumo Medical Corp.
1–100 of 143- K111606 — PINNACLE PRECISION ACCESS SYSTEM
- K111556 — GLIDECROSS SUPPORT CATHETER
- K110540 — TERUMO SUPPORT CATHETER
- K102008 — GLIDESHEATH
- K091329 — PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
- K082997 — TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER
- K090040 — RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)
- K082847 — PINNACLE ROII INTRODUCER SHEATH
- K082519 — FINECROSS MG CORONARY MICRO-GUIDE CATHETER
- K082736 — RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER
- K082644 — GLIDESHEATH
- K082362 — SURSHIELD SAFETY I.V. CATHETER
- K081045 — DESTINATION RENAL GUIDING SHEATH
- K081046 — PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
- K080563 — RUNTHROUGH NS EXTENSION WIRE
- K080415 — DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
- K071630 — TERUMO 31G THINPRO INSULIN SYRINGE
- K063695 — RUNTHROUGH NS
- K070423 — TR BAND
- K063372 — RADIFOCUS GLIDEWIRE ADVANTAGE
- K063613 — MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE
- K062446 — MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH
- K062858 — MODIFICATION TO GLIDESHEATH
- K060666 — CAROTID ACCESS KIT
- K051865 — TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR
- K052185 — DESTINATION CAROTID GUIDING SHEATH
- K052034 — TERUMO SYRINGE WITH/WITHOUT NEEDLE
- K051601 — PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
- K040531 — TERUMO SURGUARD2 SAFETY NEEDLE
- K033913 — PROGREAT
- K033583 — PROGREAT
- K031453 — TERUMO SURGUARD 2 SAFETY NEEDLE
- K024249 — TERUMO SURGUARD SAFETY SYRINGE
- K023271 — TERUMO SYRINGE WITH/WITHOUT NEEDLE
- K012854 — RENAL GUIDING SHEATH
- K013550 — CLIRANS E-SERIES DIALYZER
- K012812 — CAROTID GUIDING SHEATH
- K013164 — SURSHIELD SAFETY WINGED BLOOD COLLECTION SET
- K012646 — TERUMO 30 GAUGE HYPODERMIC NEEDLE
- K010103 — SURSHIELD WINGED INFUSION SET
- K003571 — SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE
- K003425 — CLIRANS E-SERIES HOLLOW FIBER DIALYZERS
- K003424 — PINNACLE R/O II OR RADIFOCUS INTRODUCER II
- K002026 — CAPIOX ARTERIAL FILTER
- K001474 — TERUMO U-100 INSULIN SYRING
- K993772 — X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR
- K000387 — TERUMO NEEDLE WITH LOCKING SHEATH
- K992802 — TERUMO U-100 INSULIN SYRINGE
- K991973 — CAPIOX SX10 HARDSHELL RESEVOIR
- K992051 — RADIFOCUS OPTITORQUE
- K982467 — CAPIOX CARDIOPLEGIA
- K991406 — TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETER
- K981359 — GT LEGGIERO
- K984260 — PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR)
- K982223 — CAPIOX SX HARDSHELL RESEVOIR
- K980935 — CAPIOX SX HARDSHELL RESERVOIR
- K980181 — TERUMO DISPOSABLE HYPODERMC SYRINGE
- K973516 — CAPIOX HEMOCONCENTRATOR
- K970708 — CLIRANS T-SERIES HOLLOW FIBER DIALYZERS
- K971937 — CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE
- K961734 — CAPIOX 308 HOLLOW FIBER OXYGENATOR W/INTEGRATED HEAT EXCHANGE
- K970463 — CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL RESERVOIR
- K962981 — CAPIOX SP PUMP HEAD
- K960074 — CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL VENOUS RESERVOIR
- K962667 — CAPIOX SX25 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR
- K961000 — CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIR
- K961445 — RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL
- K953940 — TERUMO RETRACTABLE NEEDLE (RN) SYRINGE
- K955801 — RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD
- K954234 — RADIFOCUS INTRODUCER II KIT
- K953533 — RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL
- K943917 — CAPIOX ARTERIAL FILTER
- K930503 — CLIRANS WET PACK HOLLOW FIBER DIALYZER
- K922799 — CAPIOX SX HOLLOW FIBER OXYGENATOR
- K926217 — TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE
- K925852 — TERUMO CORONARY GUIDE WIRE
- K926214 — GUIDE WIRE FOR LAPOROSCOPIC USE
- K924202 — RADIFOCUS(R) (CATHETER) GUIDE WIRE
- K923607 — RADIFOCUS GUIDE WIRE M
- K915337 — CAPIOX LEVEL ALARM
- K915414 — TERUMO ANGIOGTAPHIC CATHETER
- K913074 — 0.016 GUIDE WIRE FOR NEUROLOGICAL ENDOSCOPE
- K910558 — TERUMO(R) ARTERIAL AND VENOUS BLOOD LINE SET
- K911632 — CAPIOX(R) BUBBLE TRAP
- K894664 — CAPIOX HARDSHELL VENOUS RESERVOIR
- K900309 — VENOJECT II BLOOD COLLECTION TUBES
- K891234 — TERUFUSION THREE WAY STOPCOCK
- K891063 — SURFLO(R) WINGED INFUSION SET
- K891087 — TERUMO SURFLO(R) I.V. CATHETER
- K891146 — TERUMO SURFLO(R) INJECTION PLUG
- K891062 — TERUMO AV FISTULA NEEDLE SET
- K891477 — CLIRANS HOLLOW FIBER HEMODIALYZER (WET)
- K882501 — ACCUFIBRIN(TM) BLOOD COLLECTION SYSTEM AF100
- K882343 — TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT
- K881693 — TERUMO SENSIBEAD EIA PROGESTERONE KIT
- K864970 — TERUMO DENTAL NEEDLES
- K864285 — TERUMO OVATION SPECTROPHOTOMETER
- K863928 — TERUMO SENSIBEAD EIA FSH KIT
- K863138 — TERUMO RADIFOCUS GUIDE WIRE
- K863929 — TERUMO SENSIBEAD(TM) EIA HLH KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.