BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE

    FDA 510(k)
    FDA Class 2 ·Neurology

    9 SECOND DIGITAL THERMOMETER, MODEL BT-S09

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SONOVISION

    FDA 510(k)
    FDA Class 2 ·Radiology

    AMISTEM H, HA COATED STEM SIZE 3 LAT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 13, 2017

    AMISTEM H FEMORAL STEM SIZE 3 LAT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·September 25, 2015

    AMISTEM H HA COATED LAT STEM SIZE 3

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 25, 2018

    STEM: AMISTEM H HA COATED LAT STEM SIZE 3

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·January 20, 2022

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 18, 2011

    INTERSTIM

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code EZW·May 29, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·August 22, 2008

    VASO VIEW HEMOPRO

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 15, 2019

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015