BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    COOK MICROWIRE WIRE GUIDE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0104100·Caddie Lid, Tulip and Domino Connectors

    VADER Pedicle System, Rod, Carbon/PEEK, J-Rod, Ø 6.0 r000 + r450 x 40/100 mm

    FDA UDI
    icotec AG·07640164847085·VADER Pedicle System, Rod, Carbon/PEEK, J-Rod, ...

    JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CARTRIDGE

    FDA Adverse Event
    Injury ·GAMBRO RENAL PRODUCTS S.A. DE C.V.·Product code FJK·July 8, 2015

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 22, 2013

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·April 19, 2011

    UNKNOWN PRODUCT LEFT HIP

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDIC MAHWAH·Product code KWB·June 30, 2008

    COSYCOT INFANT WARMER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·January 15, 2015

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016