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

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    BOUNDARY SURGICAL DRAPE

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

    ERA® Implant Abutment Micro 0°, 2mm Cuff (AD)

    FDA UDI
    STERNGOLD DENTAL LLC·00841549106323·Implant retained overdentures are an establishe...

    DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SUTURE ANCHOR BIO-COMP SWIVELOCK C 4.75X19.1MM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code MAI·May 15, 2014

    CAPSUREFIX NOVUS MRI

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·October 31, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 2, 2015

    Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781296 (2) 781343

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·May 3, 2024

    Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781296 (2) 781343

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024