BEUDAMED
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    Philips IntelliSpace Cardiovascular

    FDA 510(k)
    FDA Class 2 ·Radiology

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707014768·CALIBRA 1ST MOL BANDS W/G8325-03 n.UL 22

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528128046·3.0 X 22mm Cannulated Headless Screw, T10

    McKesson

    FDA UDI
    MCKESSON MEDICAL-SURGICAL INC.·20612479141227·DRESSING, HYDROGEL IMPREG GZE

    Trulink

    FDA UDI
    STATCORP MEDICAL·10841522130465·BP CUFF,SL,SOFT,1T,CHILD PLUS,15-19,HP,EA

    Trulink

    FDA UDI
    STATCORP MEDICAL·10841522130526·BP CUFF,SL,SOFT,1T,CHILD PLUS,15-19,HP,5/BG

    SYNTHES (USA) CHRONOS-BETA-TCP

    FDA 510(k)
    FDA Class 2 ·Dental

    KIM

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

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·October 8, 2014

    ADVISA DR

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NVZ·June 8, 2013

    SYNCHROMED II

    FDA Adverse Event
    Death ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·June 28, 2011

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023