BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127

    FDA 510(k)
    FDA Class 2 ·Hematology

    BARD ALL-SILICONE 3-WAY FOLEY CATHETER; BARD LUBRI-SIL 3-WAY FOLEY CATHETER; BARD LUBRI-SIL I.C. 3-WAY FOLEY CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MICROMEDICS FIBRIJET AEROSOL APPLICATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RAD-8

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·July 15, 2015

    DA VINCI SI SURGICAL SYSTEM

    FDA Adverse Event
    Death ·INTUITIVE SURGICAL,INC.·Product code NAY·May 3, 2013

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·September 16, 2014

    UNK

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL- NEUROMODULATION·Product code LGW·May 11, 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