BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter

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

    CRYOTOP

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Cytosponge Cell Collection Device

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    I-STAT EC4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·July 23, 2019

    I-STAT EC4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·April 17, 2019

    REPLY

    FDA Adverse Event
    Malfunction ·SORIN CRM S.R.L.·Product code NVZ·July 8, 2011

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 11, 2013

    TERUMO ADVANCED PERFUSION SYSTEM ONE

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·September 25, 2008

    WILSON-COOK ACHALASIA BALLOON

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code PID·June 17, 2021

    WILSON-COOK ACHALASIA BALLOON

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code PID·October 6, 2020

    BD MOLECULAR SWAB COLLECTION KIT

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OUY·October 4, 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