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

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    UF(II) Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486003692·MCK BASEPLATE TRIAL (SIZE 8 LM/RL)

    n/a

    FDA UDI
    Ortho Development Corporation·00822409091676·Diamond Tooth Broaches Size 8

    SEVOFLURANE VAPORIZER ADAPTOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SMARTEP, MODEL M010000

    FDA 510(k)
    FDA Class 2 ·Neurology

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 28, 2013

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 21, 2011

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 24, 2008

    BD¿ LUER-LOK SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·July 25, 2018

    13 CM TRICUT BLADE

    FDA Adverse Event
    Malfunction ·MEDTRONIC ENT (JACKSONVILLE)·Product code HAW·July 23, 2015

    CURVED SINUS BURS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EQJ·June 2, 2014

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·January 23, 2018

    AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022