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

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    LIFTKAR PT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    JOBST ActiveWear

    FDA UDI
    BSN MEDICAL, INC.·00035664104955·ACTIVE WEAR 20-30 MM HG KNEE HIGH CLOSED TOE LA...

    CARDINAL HEALTH

    FDA UDI
    Cardinal Health 200, LLC·50885380030510·3/5cc Secure Short Cap

    Medetz Surgical Instruments

    FDA UDI
    Medetz Surgical Instruments LLC·G2231104950·Bishop-Harmon dressing forceps, 3 3/8", straigh...

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K1104250·Tray, Base, 4.25", Arcamed

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K1104250·Tray, 4.25 Inch Base

    CENTURA PHOTOTHERAPY SPOTLIGHT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PHILIPS AVENT DIGITAL THERMOMETER SET, MODEL SCH540

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GALAXY G3 MINI 2MM X 6CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·March 9, 2022

    COSYCOT INFANT WARMER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·May 14, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 23, 2014

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·April 25, 2011

    Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·August 30, 2017

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    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