BEUDAMED
    9 results · 17ms · Sources: EU EUDAMED, US FDA

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    BUFFALO FILTER REPLACEMENT FILTER #BCULPA

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

    G Surgical Marksman Spinal Deformity System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARCOS TROCHANTER BUTTON

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POWERPORT

    FDA Adverse Event
    C.R. BARD, INC.·Product code LJT·January 23, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 2, 2010

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 11, 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

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024