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

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    LOBO Vascular Occlusion System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707023654·CALIBRA BANDS 2ND MOLAR n.SLR 8

    Scorpio

    FDA UDI
    Howmedica Osteonics Corp.·07613327029970·Tibial Bearing Insert - CR

    Squadron Lumbar Cage

    FDA UDI
    VALORUS SPINE LLC·00811771034503·Squadron Lumbar TLIF Cage, 26mm x 8mm, 5°

    POINTER PLUS

    FDA 510(k)
    FDA Class 2 ·Neurology

    Electronic Pulse Stimulator

    FDA 510(k)
    FDA Class 2 ·Neurology

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 22, 2011

    RESERVOIR 1.8ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·August 1, 2013

    PENTA 3MM LEAD, 60 CM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·December 2, 2015

    BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·February 17, 2021

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014