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

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    S-LIF INTERVERTEBRAL BODY FUSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450307670·

    GOLD CORE HF PRE SOLDER

    FDA 510(k)
    FDA Class 2 ·Dental

    SAFESKIN HEALTHTOUCH POWDER-FREE EXAM GLOVE WITH VITAMIN E AND ALOE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DIDECO COMPACTFLO EVOLUTION OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·January 15, 2016

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Death ·AV-TEMECULA-CT·Product code MGB·May 3, 2013

    SERVO-I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·August 20, 2014

    8800

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD.·Product code JAA·May 5, 2011

    SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR

    FDA Adverse Event
    Death ·SORIN GROUP ITALIA SRL·Product code DTN·October 3, 2016

    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