BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    LED PRO SEAL

    FDA 510(k)
    FDA Class 2 ·Dental

    COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SIEMENS INFINITY MODULAR MONITORS MODEL SC 8000; SC 7000; SC 9000XL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 30, 2022

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·April 6, 2011

    ISERT ASPHERIC INTRAOCULAR LENS

    FDA Adverse Event
    Malfunction ·HOYA SURGICAL OPTICS INC.·Product code HQL·June 20, 2014

    SYNERGY?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·April 23, 2013

    TENDRIL SDX

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

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·February 18, 2011

    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