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

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    EksoNR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180102934·MONOPOLAR RF-CABLE WITH 120MM FEMALE BANANA (4 ...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694007184·3 Prong Midface/Micro Plate Bender

    SafeOp

    FDA UDI
    ALPHATEC SPINE, INC.·00190376189123·Left acquisition cable

    ACUMED

    FDA UDI
    Acumed LLC·10806378014826·2.7mm x 60.0mm Locking Cortical Screw

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450155592·

    ACUMED

    FDA UDI
    Acumed LLC·10806378014833·2.7mm x 60.0mm Locking Cortical Screw

    TISSUELINK BIPOLAR FLOATING BALL DEVICE

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

    IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 24, 2014

    SPRINT FIDELIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

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

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

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