BEUDAMED
    227 results · 11ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class I × Status: Terminated × Clear all

    Ventstar Coax 180, MP03374

    FDA Enforcement
    Class I ·Terminated·Draeger Medical, Inc.·May 24, 2023

    Anesthesia Circuit Kit Coax HEPA, MP17102

    FDA Enforcement
    Class I ·Terminated·Draeger Medical, Inc.·May 24, 2023

    Anesthesia Set Coax 180, MP03384

    FDA Enforcement
    Class I ·Terminated·Draeger Medical, Inc.·May 24, 2023

    VentStar Watertrap (N) 180, MP00363

    FDA Enforcement
    Class I ·Terminated·Draeger Medical, Inc.·May 24, 2023

    VentStar Bag Set (N) 110, MP00383

    FDA Enforcement
    Class I ·Terminated·Draeger Medical, Inc.·May 24, 2023

    Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

    FDA Enforcement
    Class I ·Terminated·TELEFLEX MEDICAL INC·February 23, 2022

    Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is used with the Dr¿ger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators.

    FDA Enforcement
    Class I ·Terminated·Draeger Medical, Inc.·August 10, 2016

    PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.

    FDA Enforcement
    Class I ·Terminated·Draeger Medical, Inc.·August 26, 2015

    HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics

    FDA Enforcement
    Class I ·Terminated·Hamilton Medical Inc·February 6, 2013

    PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition.

    FDA Enforcement
    Class I ·Terminated·Tytek Medical Inc·February 19, 2020

    HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit

    FDA Enforcement
    Class I ·Terminated·TELEFLEX MEDICAL INC·February 19, 2020

    HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port, REF 2416, humidifier nebulizer kit

    FDA Enforcement
    Class I ·Terminated·TELEFLEX MEDICAL INC·February 19, 2020

    HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit

    FDA Enforcement
    Class I ·Terminated·TELEFLEX MEDICAL INC·February 19, 2020

    HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, REF 2414, humidifier nebulizer kit

    FDA Enforcement
    Class I ·Terminated·TELEFLEX MEDICAL INC·February 19, 2020

    Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel port that are secured by a spring-loaded latch. Each device allows for the gentle retraction of tissue, visualization of the surgical site and for the smooth manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes.

    FDA Enforcement
    Class I ·Terminated·Vycor Medical, Inc.·January 23, 2013

    83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer, Item No. B9897. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

    FDA Enforcement
    Class I ·Terminated·ICU Medical, Inc.·October 1, 2014

    98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

    FDA Enforcement
    Class I ·Terminated·ICU Medical, Inc.·October 1, 2014

    Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.

    FDA Enforcement
    Class I ·Terminated·Bryan Medical Inc·July 17, 2013

    Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients during surgical procedures.

    FDA Enforcement
    Class I ·Terminated·Draeger Medical, Inc.·October 16, 2013

    STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9801. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

    FDA Enforcement
    Class I ·Terminated·ICU Medical, Inc.·October 1, 2014