BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    MINIMUS I; MINIMUS III, SANAPHON

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Progressive Orthopedic Total Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BATH TUB TRANSFER CHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    5.2MM TI CLICK'X® PEDICLE SCR PREASSEMBLED 40MM THRD LENGTH

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code HWC·May 26, 2017

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·February 4, 2013

    OCTRODE LEAD KIT, 60 CM LENGTH

    FDA Adverse Event
    Injury ·SJM NEUROMODULATION DIVISION·Product code LGW·December 13, 2010

    UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·July 17, 2014

    ORTHOSIS, PEDICLE SPINAL FIXATION, FOR DDD

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·August 1, 2017

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024