BEUDAMED
    16 results · 20ms · Sources: EU EUDAMED, US FDA

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    T-32;T-40;T-44;T-52;T-72;TT-50

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

    DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169523951·TRIAL 2152412 SMALL 12 DEGREES 12MM

    Eagle Derma2 Nitrile Examination Gloves

    FDA UDI
    Eagle Protect Pbc·09421024254650·Derma2 Nitrile Examination Gloves, Black, Powde...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528127551·2.4 X 12mm Cannulated Headless Screw, T7

    1.5 LACTOSORB SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036055462·

    VISTA DIGITAL OPTHALMOSCOPE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ

    FDA 510(k)
    FDA Class 2 ·Radiology

    INNOVA 4100

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS·Product code MQB·April 4, 2011

    INNOVA 4100

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS·Product code MQB·May 6, 2011

    LACTOSOR PLATES AND SCREWS

    FDA Adverse Event
    BIOMET MICROFIXATION·Product code HRS·January 25, 2011

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 7, 2013

    SYNVISC (SYNVISC)

    FDA Adverse Event
    Injury ·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·August 4, 2014

    STENOSCOP

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 28, 2011

    Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207, PSS2412(B, PSS2798, PSS2798(A, PSS2798(B, PSS3054, PSS3463, TVS4011NI(J, TVS4028(A, and TVS4070. convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024