BEUDAMED
    11 results · 27ms · Sources: EU EUDAMED, US FDA

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    SCI-PHARM POST SECURE

    FDA 510(k)
    FDA Class 2 ·Dental

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033510728·

    Cortium Universal OCT Spinal Fixation System

    FDA UDI
    Ulrich Medical Usa, Inc.·00810076339368·Cortium Screw Gauge

    SOLO-SAFE SAFETY SYRINGE, SIZE-3CC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    JAX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 12, 2012

    TI COLLAR WITH GROOVES

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code MNH·March 20, 2013

    DEFINIUM 8000

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS, LLC·Product code KPR·February 3, 2011

    KAPPA 700 DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·March 10, 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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014