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

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    P4000 PHACOEMULSIFIER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    EBI OMEGA21 SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RENOVIS BIPOLAR HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNKNOWN ORTHOSIS

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code MNI·January 6, 2017

    TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HRX·May 23, 2023

    TPRLC XR T1 PPS 17X154MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LPH·December 26, 2018

    TPRLC XR T1 PPS 15X150MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LPH·December 26, 2018

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·January 28, 2013

    AML PLUS 50MM GR2

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDL·December 15, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 14, 2014

    TPRLC XR T1 PPS 15X150MM MM T1

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LPH·April 2, 2020

    TELESCOPE "TRUEVIEW II", 4 MM, 70°, AUTOCLAVABLE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code HRX·April 24, 2023

    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024