BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    ACCIN HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRIO LX SMALL CONNECTOR

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code MNI·March 23, 2011

    SAVINA

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BIOSCANNER 2000

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    V500, SAVINA AND VENTILATORS OF EVITA FAMILY

    FDA Adverse Event
    Other ·DRAGER MEDICAL GMBH·Product code CBK·February 18, 2011

    GRAFTYS BCP (510K NUMBER: K073064)

    FDA Adverse Event
    Injury ·GRAFTYS·Product code MQV·July 11, 2013

    VERCISE GEVIA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·April 29, 2020

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 8, 2013

    M2A 38MM ONE-PIECE CUP 38MM X 52 O.D.

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·April 29, 2011

    CURRENT RF DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

    Product Name: AVEA Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

    FDA Recall
    Terminated ·Carefusion 211 Inc dba Carefusion·Product code CBK·September 5, 2013

    Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

    FDA Enforcement
    Class I ·Terminated·Carefusion 211 Inc dba Carefusion·October 9, 2013

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012