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

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    MEDISTOR II

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SMARTSCREENER-PLUS2

    FDA 510(k)
    FDA Class 2 ·Neurology

    TD-4183 Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 5, 2014

    SPRINT

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·October 15, 2012

    MIH MODULAR CUP INSERTER

    FDA Adverse Event
    Malfunction ·BIOMET ORTHOPEDICS·Product code LXH·August 10, 2010

    NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600618011, REF/Catalog No. 60061801, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

    FDA Enforcement
    Class II ·Terminated·Navilyst Medical, Inc·March 4, 2015

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018