BEUDAMED
    11 results · 35ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    KONICA QX-70 AUTOMATIC X-RAY FILM PROCESSOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    WEDGE LEG COVERED CAT ERROR NOT INTUB. POS.

    FDA UDI
    ALIMED, INC.·00733657239478·

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515240612·Maliniac General Retractor 4"

    DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)

    FDA 510(k)
    FDA Class 2 ·Radiology

    TMC ELECTRICAL SCOOTER, EASY 411

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PARADYM

    FDA Adverse Event
    Malfunction ·SORIN BIOMEDICA C.R.M., S.R.L.·Product code MRM·November 10, 2010

    1.6MM KIRSCHNER WIRE WITH 5MM THREAD-TROCAR POINT 150MM

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code JEY·January 28, 2013

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·July 14, 2014

    Lantis 8.3 Commander, Model # 8148178 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This entails selecting a patient, selecting today s treatment for that patient, setting up and delivering the treatment fields and recording the delivered treatment. Treatstation supports auto sequencing, a process of automatically downloading a group of fields or segments from the verification and record system to the control of the linear accelerator sequentially, without user intervention. In addition, Lantis Treatstation supports intensity modulation, a process of shaping, modifying and moving the beam around a target to maximize the dose at the target and minimize the dose to normal structures.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 14, 2019

    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