BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    INTERVENTIONAL HEMOSTATIC BANDAGE

    FDA 510(k)
    FDA Unclassified ·Unknown

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319704011·Iris Dressing Forceps 4" (10cm), half curved, s...

    GREENLIGHT MOXY FIBER OPTIC

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS·Product code GEX·April 18, 2013

    XVAC

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES

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

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·May 20, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·June 10, 2011

    ACRYSOF RESTOR

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD/HUNTINGTON·Product code MFK·August 15, 2008

    BD 20ML SYRINGE LUER-LOK TIP

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·July 30, 2020

    ASANTE SNAP INSULIN PUMP SYSTEM

    FDA Adverse Event
    Injury ·ASANTE SOLUTIONS INC.·Product code LZG·August 11, 2014

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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