BEUDAMED
    39 results · 12ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    Neoligaments Staple Impactor, 6 mm Staple Impactor: 202-3001

    FDA Recall
    Terminated ·Xiros Plc 28-30 Blenheim Terrace Leeds United Kingdom·Product code HXJ·May 17, 2006

    Neoligaments Staple Impactor, 8 mm Staple Impactor: 202-3010

    FDA Recall
    Terminated ·Xiros Plc 28-30 Blenheim Terrace Leeds United Kingdom·Product code HXJ·May 17, 2006

    Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·February 25, 2015

    HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·November 21, 2012

    HX2" Temperature Management Systems; The Terumo¿ HX2" Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery. The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels (Left and Right).The system has the capacity to circulate water at a rate of up to 6.5 gal.min (25 L/min) with no load connected. The system is capable of heating and cooling for a single channel or for both channels. Product Usage: HX2 Temperature Management Systems is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·July 27, 2016

    Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·November 21, 2012

    HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWC·October 16, 2012

    Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·April 25, 2018

    The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery. The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels (Left and Right). The system has the capacity to circulate water at a rate of up to 6.5 gal./min (25 L/min) with no load connected. The system is capable of heating and cooling for a single channel or for both channels. Device Name / Model Number: HX2 Temperature Management System (P/N 809810) Catalog Number: 809810

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWC·April 16, 2021

    The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery. The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels (Left and Right). The system has the capacity to circulate water at a rate of up to 6.5 gal./min (25 L/min) with no load connected. The system is capable of heating and cooling for a single channel or for both channels. Device Name / Model Number: HX2 Temperature Management System (P/N 809810) Catalog Number: 809810

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·June 9, 2021

    Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWC·March 16, 2018

    Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWC·October 16, 2012

    HX2" Temperature Management Systems; The Terumo HX2" Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery. The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels (Left and Right).The system has the capacity to circulate water at a rate of up to 6.5 gal.min (25 L/min) with no load connected. The system is capable of heating and cooling for a single channel or for both channels. Product Usage: HX2 Temperature Management Systems is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWC·June 8, 2016

    Terumo HX2 Temperature Management System 120V, 50/60 Hz catalog number 809810, Terumo Cardiovascular Systems Corp., Ann Arbor MI. The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly control the temperature of the patients blood and cardioplegia solution during cardiovascular bypass surgery. The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWC·June 11, 2010

    The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. The TCM with options will also supply water for cardioplegia, freeze water for an ice supply, monitor temperatures in the patient and extracorporeal circuit, and allow gradient rewarming relative to a venous blood temperature. Device Name / Model Number: TCM II TUV, 115V (P/N 4415), TCM II TUV, 220V (P/N 4416), Catalog Number: 4416, 164940

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWC·April 16, 2021

    The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. It also freezes water for an ice supply, monitors temperatures in the patient and extracorporeal circuit, and allows gradient rewarming relative to a venous blood temperature. The Sarns" TCM II also features a Cardioplegia System which will supply cooling water for cardioplegia. Device Name / Model Number: TCM II, with Cardioplegia, 110V/60Hz (P/N 164925) TCM II, without Cardioplegia, 110V/60Hz (P/N 164930) TCM II, with Cardioplegia, 220V/50Hz (P/N 164935) TCM II, without Cardioplegia, 220V/50Hz (P/N 164940) TCM (P/N 15747) Catalog Number: 4415, 164925, 164930, 164935, 15747

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWC·April 16, 2021

    Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWC·February 6, 2015

    Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft, and Synthes 2.0mm Milling Bit with Flat Coupling. Spinal surgical instrument: The Synthes ProDisc-C 2.0mm Milling Bits are used as a part of the milling option for keel preparation of the vertebral bodies. The milling bits are coupled to a power tool and interface with the milling guide, which is connected to a trial implant for the keel preparation step.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·June 4, 2014

    The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. The TCM with options will also supply water for cardioplegia, freeze water for an ice supply, monitor temperatures in the patient and extracorporeal circuit, and allow gradient rewarming relative to a venous blood temperature. Device Name / Model Number: TCM II TUV, 115V (P/N 4415), TCM II TUV, 220V (P/N 4416), Catalog Number: 4416, 164940

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·June 9, 2021

    Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft, and Synthes 2.0mm Milling Bit with Flat Coupling. Spinal surgical instrument: The Synthes ProDisc-C 2.0mm Milling Bits are used as a part of the milling option for keel preparation of the vertebral bodies. The milling bits are coupled to a power tool and interface with the milling guide, which is connected to a trial implant for the keel preparation step.

    FDA Recall
    Terminated ·Synthes, Inc.·Product code GFG·April 29, 2014