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

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    CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554

    FDA 510(k)
    FDA Class 2 ·Hematology

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704293906·

    PF4 IGG

    FDA Adverse Event
    Malfunction ·IMMUCOR GTI DIAGNOSTICS·Product code GWG·January 16, 2015

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 12, 2023

    POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MICROPAQ, MODELS 402, 404

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CAPSURE SENSE

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

    PINNACLE MTL INS NEUT36IDX52OD

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

    STERRAD 200 STERILIZATION SYSTEM

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·July 8, 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

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

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