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

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    SEPRAGEL ENT BIORESORBABLE PACKING/STENT

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    APOLLO Ankle Fracture Plating System

    FDA UDI
    Glw, Inc.·18435711004150·APOLLO Ankle Fracture Plates / 4.3mm / Non-Lock...

    Valkyrie Thoracic Fixation System

    FDA UDI
    J.M. Longyear Manufacturing, LLC·00810071390135·Driver Bit, Short

    CLARREN HELMET

    FDA 510(k)
    FDA Class 2 ·Neurology

    GUARDIAN LIMB SALVAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYSTEM CONSOLE

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·March 7, 2013

    THERMOPHORE ARTHRITIS PAD

    FDA Adverse Event
    Malfunction ·BATTLE CREEK EQUIPMENT COMPANY·Product code IRT·March 15, 2011

    FLEXTEND IS-1 BI POSITIVE FIX

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code NVN·May 8, 2008

    BD¿ BULK, NON-STERILE NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·July 16, 2019

    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

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018