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

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    BOSTON BAND

    FDA 510(k)
    FDA Class 2 ·Neurology

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213026162·microSelectron Transfer Tube for 4F Flexibles (27)

    Specials

    FDA UDI
    Seaspine Orthopedics Corporation·10889981319779·16x14x09 Trial Rasp, w/ Depth Stop

    SELF RETAINING SOFT TISSUE RETRACTOR

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    LIVESURE AMPHETAMINE SCREEN TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Ascendant

    FDA UDI
    Choice Spine, LP·10885862260819·

    STEM: AMISTEM P AMISTEM-P STD STEM SIZE 8

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·June 14, 2024

    OCTRODE LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code LGW·September 9, 2022

    SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions.

    FDA Enforcement
    Class II ·Terminated·Stelkast Co·September 11, 2013

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·May 6, 2013

    N/A

    FDA Adverse Event
    Injury ·ASCENT·Product code KTT·June 2, 2011

    LIGHTSPEED HP60

    FDA Adverse Event
    Malfunction ·GE YOKOGAWA MEDICAL SYSTEMS·Product code JAK·August 13, 2008

    PANTHER FUSION ADV/HMPV/RV ASSAY

    FDA Adverse Event
    Injury ·HOLOGIC INCORPORATED·Product code OCC·October 12, 2021

    PANTHER FUSION SARS-COV-2 ASSAY PPR SOLUTION

    FDA Adverse Event
    Malfunction ·HOLOGIC INCORPORATED·Product code QJR·October 11, 2021

    DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025