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

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    Accurate Multi Panel Drug Urine Test Cup

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·March 17, 2015

    ACCENT DR RF

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 13, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·June 26, 2013

    EPIC II CRITICAL CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·July 29, 2011

    Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 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

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024