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

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    KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·July 24, 2021

    Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    I-STYLE BONE MARROW ASPIRATION NEEDLE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TERUMO STERNAL SAW II

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code GFA·February 11, 2013

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2014

    GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA

    FDA Adverse Event
    Malfunction ·OBTECH MEDICAL SARL_·Product code LTI·January 14, 2011

    Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 6, 2016