BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    MTG - MINITUB HEATED STAGE SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ISOLA SPINAL SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AMI

    FDA Adverse Event
    Other ·AIRWAY MANAGEMENT INC.·Product code LRK·July 10, 2013

    5.0MM FLEXIBLE SHAFT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTO·April 17, 2013

    ISERT ASPHERIC INTRAOCULAR LENS

    FDA Adverse Event
    Malfunction ·HOYA SURGICAL OPTICS, INC.·Product code HQL·March 21, 2011

    SURGAIRTOME TWO HANDPIECE

    FDA Adverse Event
    Malfunction ·CONMED LINVATEC·Product code GET·June 16, 2008

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015