BEUDAMED
    11 results · 18ms · Sources: EU EUDAMED, US FDA

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    S & S ORTHOPEDIC WIRE DRIVER 701

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    KALTOSTAT WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·August 11, 2021

    EYE SURGERY STRETCHER OBS 3/07

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·February 5, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·December 28, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 18, 2014

    HF-RESECTION ELECTRODE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023

    HF-RESECTION ELECTRODE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023

    UNKNOWN

    FDA Adverse Event
    Injury ·OLYMPUS WINTER & IBE GMBH·Product code KNS·October 21, 2022

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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