BEUDAMED
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    MODIFICATION TO ZENIEVA

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Harvard PremiumSil Mono

    FDA UDI
    Harvard Dental International GmbH·EHAR70837211·Vinylpolysiloxane impression material, super hy...

    BD LUER-LOK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 19, 2023

    MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·July 14, 2022

    SINAI HSP BALTIMORE MD 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·July 6, 2011

    LAKELAND REG LAKELAND FL 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DWF·May 3, 2010

    WA ADVENT TAKOMA PARK MD 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·November 22, 2011

    IOWA METH DES MOINES IA1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code DTZ·March 7, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·April 29, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·May 10, 2011

    GE OEC 9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 28, 2008

    Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021