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

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    BIS EEG VISTA MONITOR SYSTEM AND BISX

    FDA 510(k)
    FDA Class 2 ·Neurology

    SideStream

    FDA UDI
    RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD·00383730001081·SideStream Reusable with Tucker Mask, Retail, 1...

    DELTA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613252275664·S-DRILLING TAP, DENT, FOR 6mm SCREW

    Genius Total Knee System

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215022198·

    Crescendo Meniscal Insert CR Ultracongruent 17mm Size 6

    FDA UDI
    AMPLITUDE SAS·03701089524995·

    MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LDOB OCCLUSION BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 8, 2024

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·April 23, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·April 28, 2011

    MAXIMO VR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·July 10, 2008

    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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012