BEUDAMED
    12 results · 27ms · Sources: EU EUDAMED, US FDA

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    VISI-STAPH

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Gentle Threads

    FDA UDI
    Biomet Orthopedics, LLC·00880304006669·

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111122927·RECAMIER CURETTE SH 12.5 #6

    SERATEST ENA [SSA] KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (ECTR)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GENTLE THREAD 9X30MM FULL THRD

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

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·May 28, 2014

    DARCO(R) BOW II PLATE

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC·Product code HRS·January 9, 2013

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORP.·Product code MKJ·November 12, 2010

    Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment procedures in the ankle/foot and knee.

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

    Monoject Blunt Cannula, 19 G x 1-1/2" (1.067 mm x 3.8 cm) Item code: 8881202355

    FDA Enforcement
    Class II ·Completed·Cardinal Health 200, LLC·July 31, 2019

    Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment procedures in the ankle/foot and knee.

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