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

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    Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MICRONAIL Distal Radius System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IMP,TSV,MCOL MG,3.7MM,11.5MML

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code DZE·August 3, 2022

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Death ·ZOLL MANUFACTURING CORPORATION·Product code MVK·November 7, 2014

    PARIETEX UGYTEX PP ANTERIOR KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·September 9, 2011

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 26, 2013

    IMP,TSV,MCOL MG,3.7MM,11.5MML

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code DZE·August 3, 2022

    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

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013