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

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    APEX MEDICAL DIGITAL TENS TS1211, TS1212

    FDA 510(k)
    FDA Class 2 ·Neurology

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074034546·BONE SCREW 7021755 10 DEG ILC 7.5X55 SS

    STRYKER T4 HYTREL (R) TOGAS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MPW HEMODIALYSIS WATER PURIFICATION SYSTEM

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

    RADIESSE DERMAL FILLER

    FDA Adverse Event
    Injury ·MERZ AESTHETICS, INC·Product code LMH·May 2, 2011

    RENU WITH MOISTURELOC MULTIPURPOSE SOLUTION

    FDA Adverse Event
    Injury ·BAUSCH & LOMB INCORPORATED·Product code LPN·February 18, 2020

    COBAS 6000 C501 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·March 26, 2013

    NC QUANTUM APEX PTCA DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·March 17, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·March 19, 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