BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    R3 Anteverted Liners

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML

    FDA 510(k)
    FDA Class 2 ·Microbiology

    COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AMISTEM-P STD STEM SIZE 7

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 8, 2019

    STEM: AMISTEM P AMISTEM-P STD STEM SIZE 7

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 11, 2019

    ENDURANT

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code MIH·October 17, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 14, 2013

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·July 11, 2011

    MENTOR CPX4 WITH SUTURE TABS, TALL HEIGHT, SMOOTH

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·October 24, 2019

    MENTOR CPX4 WITH SUTURE TABS, MED HEIGHT, SMOOTH

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·January 10, 2020

    CPX4 PLUS SMOOTH TALL HEIGHT 550CC

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·April 19, 2022

    CPX4 WITH SUTURE TABS MEDIUM HEIGHT SMOOTH EXPANDER

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·February 22, 2021

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012