BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    NEURONAV SYSTEM AND NEURONAV DRIVE

    FDA 510(k)
    FDA Class 2 ·Neurology

    GLUCOSE CONTROL SOLUTION FOR BD LATITUDE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    EBI XFIX ACCESS PELVIC FIXATOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNK - SCREW

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code KWQ·July 26, 2011

    UNK - SCREW

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code KWQ·July 26, 2011

    UNK - SCREW

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code KWA·July 26, 2011

    UNK - SCREW

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code KWQ·July 26, 2011

    CAPSURE SP

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·April 22, 2013

    ASR 300 SPIKED CUP SIZE 48

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 15, 2011

    CIDEX OPA CONCENTRATE

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code LRJ·July 9, 2008

    IRIDEX IQ577 LASER SYSTEM

    FDA Adverse Event
    Injury ·IRIDEX CORP.·Product code GEX·November 4, 2013

    Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·October 7, 2020

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018