BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Gentle Threads

    FDA UDI
    Biomet Orthopedics, LLC·00880304006676·

    Pyramesh® Implant System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000856564·MESH 905-608 PYRM 16MM X 8MM ROUND

    Pyramesh® Implant System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00673978081069·MESH 905-608 PYRM 16MM X 8MM ROUND

    SHEPPERD LUMBAR DISCECTOMY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HPI POWDER FREE NON-STERILE EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    GENTLE THREAD 9X25MM ROUND HD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HWC·January 11, 2023

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 9, 2013

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·November 19, 2010

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NIK·July 1, 2014

    Gentle Threads, Interference Screw; Model No. 905608, for soft tissue reattachment procedures in the ankle/foot and knee.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·May 16, 2018

    GENTLE THREAD 8X25MM FULL THRD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HWC·January 23, 2023

    GENTLE THREAD 8X25MM FULL THRD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HWC·July 20, 2022

    GENTLE THREAD 9X25MM ROUND HD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HWC·January 18, 2023

    Gentle Threads, Interference Screw; Model No. 905608, for soft tissue reattachment procedures in the ankle/foot and knee.

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code HWC·March 28, 2018

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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