BEUDAMED
    15 results · 29ms · Sources: EU EUDAMED, US FDA

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    INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301

    FDA 510(k)
    FDA Unclassified ·Unknown

    Vial Adaptor

    FDA UDI
    WEST PHARMA. SERVICES IL, . LTD·07290108240436·Vial Adapter 20mm FLL w/15μm Filter - SF

    CTXA Hip Bone Mineral Densitometer

    FDA UDI
    MINDWAYS SOFTWARE, INC.·B052DICTXAHIP0·The CTXA Hip Bone Mineral Densitometer (CTXA Hi...

    Optimus Drill Q Cross Pin 1.5x7.5 mm

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215061821·

    Genius Total Knee System

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215022303·

    CTXA HIP; CTXA; QCT PRO CTXA HIP

    FDA 510(k)
    FDA Class 2 ·Radiology

    INDWELLING FECAL MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Crescendo Meniscal Insert CR Standard 12mm Size 3

    FDA UDI
    AMPLITUDE SAS·03701089524339·

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013

    JELCO PROTECTIV

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD·Product code FOZ·April 13, 2011

    MARQUIS DR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code LWS·July 10, 2008

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022