BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    Haymaker® Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EVA15

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

    TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CFR03, 5X100 KII OPT ADVFIX 6/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL·Product code GCJ·February 23, 2015

    BOLT CUTTER HEAD FOR 5.0MM FIXATION PINS XL

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code FZT·November 4, 2014

    ACCESS

    FDA Adverse Event
    Malfunction ·BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS·Product code FPA·August 25, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 12, 2013

    MENTOR SILTEX ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·March 2, 2018

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018