BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    ABBOTT ACCLAIM ENCORE, MODEL 12237

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040013663·Zirlux 16+ B4 98.5X16

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K01109T0·Cervical Trial, 14 x 11, 9mm, 7 Degree, Tapered

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K01109N0·Cervical Trial, 14 x 11, 9mm, 0 Degree, No Taper

    BURR HOLE COVER, MODEL XX

    FDA 510(k)
    FDA Class 2 ·Neurology

    MULTI CARE THERAPEUTIC VIBRATOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    BD PLASTIPAK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·October 29, 2021

    XMAX MOTOR

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code ERL·March 14, 2013

    SACRAL CANNULATED POLYAXIAL SCREW 6.5MM X 35MM, TI

    FDA Adverse Event
    Injury ·ALPHATEC SPINE INC·Product code KWP·March 8, 2011

    TENDRIL SDX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL AB·Product code DTB·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

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021