BEUDAMED
    21 results · 22ms · Sources: EU EUDAMED, US FDA

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    Radiance V3

    FDA 510(k)
    FDA Class 2 ·Radiology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517575500·CoRoent Ant TLIF Ti, 15x13x36mm 8°

    GEN4 Direct Access

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828103374·GEN4 Direct Access

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111060427·SKLHN POTTS-SMITH 60 DEG 7"

    AGC KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304222144·

    BINAXNOW COVID-19 ANTIGEN SELF TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC·Product code QKP·July 12, 2021

    BINAXNOW¿ COVID-19 ANTIGEN SELF TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 11, 2021

    BINAXNOW COVID-19 AG SELF TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·July 30, 2021

    BINAXNOW COVID-19 AG SELF TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·July 12, 2021

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCABOROUGH·Product code QKP·August 20, 2021

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 15, 2021

    HAIRMAX LASERCOMB

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    INTERPROXIMAL REDUCTION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Dental

    NIM

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code ETN·August 4, 2021

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 8, 2013

    GORE INTERING® VASCULAR GRAFT

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code DSY·October 8, 2014

    WALLSTENT BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·August 21, 2008

    NIM® EMG ELECTRODE

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code GXZ·August 10, 2017

    3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Product Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·June 1, 2016

    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