BEUDAMED
    14 results · 18ms · Sources: EU EUDAMED, US FDA

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    REFLOTRON CREATININE TEST TABS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VERTE-SPAN® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00721902035388·OTHER 8913105 VRTSPN THORACIC CYLINDER L

    REVELATION DIAMOND

    FDA UDI
    Ss White Burs, Inc.·D6909131052·REVELATION DIAMOND 858-008F - 5 PACK

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613069711·Iris Scissors, Straight, Two Tone Finish, Overa...

    McKesson

    FDA UDI
    MCKESSON MEDICAL-SURGICAL INC.·20612479275946·Procedure face masks Level 3

    Novo Surgical

    FDA UDI
    NOVO SURGICAL, INC.·G5869131050·osteotome caps, gas or steam permeable, latex-f...

    TEMPUSIC PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AMS GREENLIGHT HPS FIBER

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS·Product code GEX·January 8, 2013

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·December 2, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 14, 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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·August 28, 2024