11 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired.
FDA Enforcement
Class I
·Terminated·Codman & Shurtleff, Inc.·January 29, 2014
TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. The system is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (AVMs) via superselective catheter delivery.
FDA Enforcement
Class I
·Terminated·Codman & Shurtleff, Inc.·January 29, 2014
TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023
TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023
TruSignal Ear Sensor, REF TS-E-D; Oximeter
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023
TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023
TruSignal Wrap Sensor, REF TS-W-D; Oximeter
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms)
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023
TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023
TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023