BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575172320·Knee femur prosthesis trial - Megasystem-C Tumo...

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575180288·Knee femur prosthesis trial - Megasystem-C Tumo...

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575172351·Knee femur prosthesis trial - Megasystem-C Tumo...

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575180295·Knee femur prosthesis trial - Megasystem-C Tumo...

    GM HELIX ACQUA IMPLANT,TI,5.0X16

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·May 16, 2018

    MODIFICATION TO BIOMARC TISSUE MARKER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DOSEVIEW 3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    GM HELIX IMPLANT 4.3X13

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·June 6, 2018

    GM HELIX IMPLANT 4.3X13

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·June 22, 2018

    GM DRIVE ACQUA IMPLANT 3.5X8 MM

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·August 29, 2018

    GM HELIX ACQUA IMPLANT 3.75X11.5

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·April 24, 2018

    SLEEPSTYLE AUTO

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·January 2, 2025

    SLEEPSTYLE AUTO

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·February 18, 2025

    GM HELIX IMPLANT 3.5X10

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·June 29, 2018

    SLEEPSTYLE AUTO

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·September 12, 2024

    GM HELIX ACQUA IMPLANT 3.5X11.5

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·April 24, 2018

    GM DRIVE IMPLANT 3.5X10

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·April 20, 2018

    SLEEPSTYLE AUTO

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·November 14, 2024

    STARKEY

    FDA UDI
    Starkey Laboratories, Inc.·00842318179340·