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

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    EAGLE EYE PLATINUM DIGITAL IVUS CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09

    FDA 510(k)
    FDA Unclassified ·Unknown

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIQ·May 3, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·September 8, 2014

    LEAD MODEL 304

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·May 9, 2011

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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