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

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    Automatic Digital Blood Pressure Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SMITH & NEPHEW HIP SYSTEMS WITH HA

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIGITAL EYE-FUNDUS CAMERA

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·June 21, 2013

    PARADYM

    FDA Adverse Event
    Injury ·SORIN CRM S.R.L.·Product code MRM·July 29, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 21, 2014

    Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·April 27, 2016