BEUDAMED
    9 results · 32ms · Sources: EU EUDAMED, US FDA

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    GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE

    FDA 510(k)
    FDA Class 2 ·Dental

    RANDOX GLUCOSE (GOD/PAP)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    POLYFLUX 17L

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER·Product code KDI·January 14, 2020

    INGENIO

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 9, 2013

    EASYPUMP

    FDA Adverse Event
    Malfunction ·I-FLOW CORP.·Product code MEB·February 25, 2011

    CONTAK RENEWAL 3

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 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,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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