BEUDAMED
    18 results · 31ms · Sources: EU EUDAMED, US FDA

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    BENEVIEW T SERIES PATIENT MONITORS, MODELS T8, T6 AND T5

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VARIANT II TOTAL GHB

    FDA 510(k)
    FDA Class 2 ·Hematology

    STERILOX LIQUID CHEMICAL STERILANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FR CLERMONT FERRAND

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·October 3, 2012

    MERCY HSP PITTSBURGH PA 1

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DWE·May 7, 2009

    ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·July 17, 2014

    ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·July 17, 2014

    HCSG/HENDRICK MED/ABLNE TX 1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code DWE·February 16, 2010

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·November 24, 2017

    DIDECO COMPACTFLO EVO

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·January 16, 2013

    DIDECO COMPACTFLO EVO

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code KFM·December 13, 2012

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·November 15, 2016

    DIDECO COMPACTFLO EVO

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·October 18, 2012

    ASR ACETABULAR CUPS 48

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·April 23, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 1, 2011

    VICTORY XL DR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·July 11, 2008

    Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·February 26, 2020

    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