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

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Spirit One A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·May 4, 2016

    Spirit One A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·May 4, 2016

    Powered stretcher chair used during facial and eye surgeries. One chair per package.

    FDA Enforcement
    Class II ·Terminated·TransMotion Medical Inc·January 28, 2015

    CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one chair wrapped in a blanket if delivered in person. Recliner provides heat and massage after surgery.

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·August 28, 2013

    Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position.

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·October 2, 2013

    Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333 -6900.

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·August 19, 2015

    Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities. Additionally, angiographic procedures can be performed in the operating room, image guided surgery by x-ray, by image fusion, and by navigation systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·February 25, 2015

    PORT-A-CATH¿ II POWER P.A.C. Low Profile" system.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·July 15, 2020

    BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·February 16, 2022

    Canon Aquilion One Vision, Model TSX-301C

    FDA Enforcement
    Class II ·Ongoing·Canon Medical System, USA, INC.·April 22, 2020

    Canon Aquilion One, Model TSX-301A

    FDA Enforcement
    Class II ·Ongoing·Canon Medical System, USA, INC.·April 22, 2020

    Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (TA-UB1) is a rechargeable power source for the Thermal Angel Blood and IV Fluid Infusion Warmer. The TA-UB1 battery was designed to provide sufficient power for the Thermal Angel to warm and deliver one liter of blood or IV fluid infusion to a trauma patient.

    FDA Enforcement
    Class II ·Terminated·Estill Medical Technologies, Inc·October 29, 2014

    MyLab Seven, Model 6400

    FDA Enforcement
    Class II ·Terminated·ESAOTE S.P.A.·October 31, 2018

    MyLab Gamma, Model 7410

    FDA Enforcement
    Class II ·Terminated·ESAOTE S.P.A.·October 31, 2018

    MyLab Alpha, Model 7400

    FDA Enforcement
    Class II ·Terminated·ESAOTE S.P.A.·October 31, 2018

    Giraffe OmniBed Ohmeda Medical Giraffe OmniBed- The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperatures controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

    FDA Enforcement
    Class II ·Terminated·Ohmeda Medical·March 29, 2017

    Natus Warmette Blanket Cabinet and Warmette Dual Cabinet The Natus Warmette Blanket Cabinet is designed to store and warm blankets and hospital linens; while, the Natus Warmette Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment and fluids (irrigation and/or injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items

    FDA Enforcement
    Class II ·Terminated·Natus Manufacturing Limited·January 18, 2017

    SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack, which is an external battery pack used to power one MED-EL SONNET control unit. It can be worn on the upper body or the hip using different SONNET Mini Battery Pack Cable lengths to connect the SONNET Mini Battery Pack to one processor unit.

    FDA Enforcement
    Class II ·Terminated·MED-EL Elektromedizinische Gereate, Gmbh·March 8, 2017

    Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1

    FDA Enforcement
    Class II ·Ongoing·Canon Medical System, USA, INC.·April 22, 2020

    System 1 Base, 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·July 25, 2012