BEUDAMED
    10 results · 23ms · Sources: EU EUDAMED, US FDA

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    ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW

    FDA 510(k)
    FDA Class 2 ·Dental

    THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR

    FDA 510(k)
    FDA Class 2 ·Immunology

    RANDOX PHENYTOIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    REBOUND HRD

    FDA Adverse Event
    Malfunction ·MINNESOTA MEDICAL DEVELOPMENT, INC.·Product code FTL·May 16, 2011

    SETROX S 53

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG,·Product code NVZ·April 29, 2011

    PROMOTE RF CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC., CRMD·Product code NIK·January 14, 2014

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 26, 2013

    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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012