BEUDAMED
    20 results · 26ms · Sources: EU EUDAMED, US FDA

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    SOMAVAC Device

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

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486000721·MCK Onlay Tibia Baseplate

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481121456·LOCATOR R-Tx Abutment for 4.2mm Platform Intern...

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481121395·LOCATOR F-Tx Abutment for 4.2mm Platform Intern...

    MAKO UKR X3 ONLAY INSERT SIZE 6 - 8 MM

    FDA Adverse Event
    Injury ·MAKO SURGICAL CORP.·Product code NPJ·April 17, 2024

    VATEA ENDONTIC IRRIGATION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Dental

    ALATECH POWDERED LATEX PATIENT EXAMINATION GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    UNKNOWN CEMENT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·July 26, 2018

    MAKO 6 UNI BASEPLATE

    FDA Adverse Event
    Injury ·MAKO SURGICAL CORP.·Product code NPJ·July 26, 2018

    MAKO UKR X3 ONLAY INSERT SIZE 6 - 8 MM

    FDA Adverse Event
    Injury ·MAKO SURGICAL CORP.·Product code NPJ·August 1, 2023

    MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 6 - 8 MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code NPJ·July 30, 2021

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 17, 2014

    DECKER RONGEUR'S - METREX

    FDA Adverse Event
    Malfunction ·MEDTRONIC·Product code HTX·July 12, 2011

    ANTHEM RF

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·June 20, 2013

    MAKO UKR X3 ONLAY INSERT SIZE 6 - 8 MM

    FDA Adverse Event
    Injury ·MAKO SURGICAL CORP.·Product code NPJ·October 24, 2024

    MCK TIBIAL BASEPLATE-LM/RL-SZ 6

    FDA Adverse Event
    Injury ·MAKO SURGICAL CORP.·Product code NPJ·January 26, 2023

    MCK FEMORAL-LM-RL-SZ 5

    FDA Adverse Event
    Injury ·MAKO SURGICAL CORP.·Product code NPJ·August 16, 2016

    MCK TIBIAL ONLAY INSERT-SZ 6-8MM

    FDA Adverse Event
    Injury ·MAKO SURGICAL CORP.·Product code NPJ·August 7, 2017

    MCK TIBIAL ONLAY INSERT-SZ 6-8MM

    FDA Adverse Event
    Injury ·MAKO SURGICAL CORP.·Product code NPJ·November 24, 2015

    Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.

    FDA Enforcement
    Class II ·Terminated·Mako Surgical Corporation·March 9, 2016