BEUDAMED
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    PIO ROOT CANAL INDICATOR

    FDA 510(k)
    FDA Class 1 ·Dental

    ALLURA XPER FD

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·June 13, 2023

    KII PIOS FIRST ENTRY 5X100

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL·Product code GCJ·December 20, 2016

    640G INSULIN PUMP MMT-1712K

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·September 9, 2021

    BARD

    FDA Adverse Event
    Malfunction ·BARD P.V.·Product code DTK·March 22, 2006

    670G INSULIN PUMP MMT-1780KL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·July 9, 2024

    PUMP MMT-1782KL 670G MM RPL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·March 25, 2024

    PUMP MMT-1781K 670G V4.11 MG

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·November 20, 2023

    IMPLANTABLE COLLAMER LENS (ICL)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code MTA·October 11, 2021

    IMPLANTABLE COLLAMER LENS (ICL)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code MTA·April 18, 2022

    IMPLANTABLE COLLAMER LENS (ICL)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code QCB·February 23, 2024

    IMPLANTABLE COLLAMER LENS (ICL)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code QCB·February 23, 2024

    Duceram® Kiss

    FDA UDI
    DeguDent GmbH·EDD153609035600·

    630G INSULIN PUMP MMT-1715K 630G BLACK MG

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·April 26, 2019

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·March 13, 2019

    Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.

    FDA Enforcement
    Class II ·Ongoing·LeMaitre Vascular, Inc.·May 21, 2025

    IMPLANTABLE COLLAMER LENS (ICL)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code QCB·April 5, 2021

    IMPLANTABLE COLLAMER LENS (ICL)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code QCB·April 12, 2021

    640G INSULIN PUMP MMT-1712K

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 23, 2018

    IMPLANTABLE COLLAMER LENS (ICL)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code QCB·October 1, 2024