BEUDAMED
    13 results · 30ms · Sources: EU EUDAMED, US FDA

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    SVED WOUND TREATMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HAKIM PROGRAMMER AND TRANSMITTER

    FDA 510(k)
    FDA Class 2 ·Neurology

    EDWARDS ESHEATH INTRODUCER SET

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·December 6, 2021

    EDWARDS TF SHEATH UNKNOWN

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·October 30, 2021

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code HET·May 6, 2013

    ZURICH MAXDRIVE SCREW

    FDA Adverse Event
    Injury ·KARL LEIBINGER MEDIZINTECHNIK GMBH U. CO. KG·Product code MQN·September 3, 2014

    VASOVIEW HEMOPRO EVH SYSTEM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR·Product code GEI·April 6, 2011

    SHELL POROUS WITH CLUSTER HOLES

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code LPH·May 26, 2017

    INCLUSIVE TAPERED IMPLANT 4.7MMD X 11.5 MML X 4.5 MMP

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·June 22, 2022

    GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016

    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

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024