BEUDAMED
    12 results · 24ms · Sources: EU EUDAMED, US FDA

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    da Vinci Xi Surgical System

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

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486004590·MCK INLAY TRIAL (SIZE 3 X 7.5mm)

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486004583·MCK INLAY TRIAL (SIZE 3 X 6.5mm)

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486004606·MCK INLAY TRIAL (SIZE 3 X 8.5mm)

    WATERPAP VALVE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    IMPLANT LOCATION SOFTWARE-T

    FDA 510(k)
    FDA Class 2 ·Radiology

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·April 24, 2019

    STR THOR CATH 24FR

    FDA Adverse Event
    Injury ·COVIDIEN·Product code KDQ·July 12, 2011

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 14, 2013

    INTERSTIM

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code EZW·September 16, 2008

    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

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020