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

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    Filters Regulation: Us FDA ×

    UNIVERSAL EYESHIELD

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    NEMECTRODYN MODEL 2 & ENDOVAC 2 POWER MUSCLE STIM.

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PARADYM

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA S.R.L. - CRM FACILITY·Product code MRM·June 25, 2014

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Injury ·HEARTWARE, INC·Product code DSQ·July 7, 2015

    M2A 38MMX54MM CUP

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·January 3, 2013

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020