BEUDAMED
    10 results · 33ms · 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.

    16 X 125 MM TEST TUBE, CATALOG #01-421

    FDA 510(k)
    FDA Class 1 ·Hematology

    LONG NAIL KIT R2.0, TI, LEFT GAMMA3 ?11X380MMX12

    FDA Adverse Event
    Injury ·STRYKER TRAUMA GMBH·Product code HSB·October 30, 2012

    IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    COMPRESSIBLE LIMB SLEEVE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    OPTIVANTAGE DH

    FDA Adverse Event
    Injury ·LIEBEL-FLARSHEIM CO.·Product code DXT·January 22, 2013

    COBAS INTEGRA CALCIUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CIC·December 16, 2010

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 11, 2014

    Lantis Commander, Model # 4503178 - 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