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

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    ViziShot FLEX

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690124672·Modular Offset Stem 9mm x 125mm 2mm

    BINAXNOW¿ COVID-19 ANTIGEN SELF TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCABOROUGH·Product code QKP·May 31, 2021

    GREAT GLOVE POWDERED VINYL EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    HARDYCHROM MRSA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·October 8, 2014

    SPRINT QUATTRO

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 8, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 17, 2011

    SPYSCOPE DS II ACCESS & DELIVERY CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 30, 2020

    SPYSCOPE DS II ACCESS & DELIVERY CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 23, 2020

    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022