BEUDAMED
    13 results · 22ms · Sources: EU EUDAMED, US FDA

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    KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120

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

    UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COPELAND MB/HA RESURFACING HUMERAL HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VANGUARD PFR FEMORAL LT SM

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code KRR·May 17, 2018

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 22, 2013

    PHYSIOMESH

    FDA Adverse Event
    Injury ·ETHICON·Product code FTL·April 27, 2011

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·July 3, 2008

    KYPHON KURVE BONE FILLER DEVICE 13GA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO·Product code KIH·July 14, 2020

    ABBOTT TUBE EDTA PLH 13X75 2.0 PNK

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·August 3, 2022

    ABBOTT TUBE EDTA PLH 13X75 2.0 PNK

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·September 17, 2019

    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