BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    Absorbable Cranial Flap Fixation System

    FDA 510(k)
    FDA Class 2 ·Neurology

    BD BBL™ Port-A-Cul™ Tube

    FDA UDI
    BECTON, DICKINSON AND COMPANY·30382902216064·BD BBL™ Port-A-Cul™ Tube

    BLACKHAWK Cervical Spacer System

    FDA UDI
    Choice Spine, LP·00840996164603·BLACKHAWK,STERILE,PARALLEL,16X14X6

    RESORB-X G

    FDA 510(k)
    FDA Class 2 ·Neurology

    EN-SNARE ENDOVASCULAR SNARE AND CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BBL Port A Cul tubes, catalog number 221606. Patient sample collection tubes. BBL Port A Cul tubes, jars and vials contain a reduced transport medium and are intended to maintain the viability of anaerobic, facultative and aerobic microorganisms during transport from the patient to the laboratory. Sterile packages are for collection of specimens in clean areas; e.g., surgical suites.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·June 17, 2015

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·November 3, 2014

    PFNA 10 130 DEGREE L240 TAN

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HSB·August 19, 2011

    HIRES 90K IMPLANT

    FDA Adverse Event
    Injury ·ADVANCED BIONICS LLC·Product code MCM·July 9, 2013

    BBL Port A Cul tubes, catalog number 221606. Patient sample collection tubes. BBL Port A Cul tubes, jars and vials contain a reduced transport medium and are intended to maintain the viability of anaerobic, facultative and aerobic microorganisms during transport from the patient to the laboratory. Sterile packages are for collection of specimens in clean areas; e.g., surgical suites.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code N/A·November 21, 2014

    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