BEUDAMED
    16 results · 29ms · Sources: EU EUDAMED, US FDA

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    Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LINA XCISE MODEL MOR-1515

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PROVEN STEM EXTENDER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC 12/14 Ø 28 SIZE L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 14, 2021

    MPACT DM DOUBLE MOBILITY HC LINER Ø 50/28

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·July 30, 2019

    LINER: MPACT DM DOUBLE MOBILITY HC LINER 22.2/DMC

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·December 7, 2020

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

    RESTORE ADVANCED RECHARGEABLE

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 5, 2011

    UNKNOWN COVIDIEN RFA PRODUCT

    FDA Adverse Event
    Injury ·COVIDIEN·Product code GEI·June 14, 2013

    LINER: MPACT DM DM CONVERTER TIN COATED D/DMB

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·June 27, 2024

    STEM: M-VIZION PROXIMAL BODY Ø20MM L 90MM STD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 9, 2024

    EPIQ 7C ULTRASOUND CHINA LOCAL

    FDA Adverse Event
    Malfunction ·PHILIPS ULTRASOUND (SHANGHAI) CO., LTD·Product code IYN·June 2, 2023

    CUP: MPACT ACETABULAR SHELL Ø56 MULTI-HOLE

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·March 1, 2022

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 13, 2022

    MPACT DOUBLE MOBILITY SHELLS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·February 21, 2024

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021