BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    XIDF-100A/B1 IMAGE PROCESSOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    PORTABLE NON-CONTACT TONOMETER, MODEL PT100

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PROMUS ELEMENT¿ PLUS

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

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 9, 2014

    TENDRIL SDX

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

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024