BEUDAMED
    11 results · 33ms · Sources: EU EUDAMED, US FDA

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    LIFEPAK 10 DEFIBRILLATOR/MONITOR W/OPT PACEMAKER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VARIAX

    FDA UDI
    Stryker GmbH·07613154627356·Inlay 2 for Basic Plate Module

    ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BOOT ASSEMBLY

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·August 7, 2019

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·September 12, 2016

    COBAS 6000 E601 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GMN·December 17, 2010

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·January 28, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 14, 2014

    Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2015

    Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 2, 2014