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

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    NvisionVLE Low-profile Optical Probe

    FDA 510(k)
    FDA Class 2 ·Radiology

    NOVO Surgical

    FDA UDI
    NOVO SURGICAL, INC.·00842331184154·McPherson Iris Bipolar Forceps, 0.25 mm tip, 3-...

    LEV-OR DILATION CATHETER OTW

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA

    FDA 510(k)
    FDA Class 2 ·Radiology

    NI

    FDA Adverse Event
    Death ·DEXCOM, INC.·Product code MDS·June 17, 2016

    CURLIN IV PUMP

    FDA Adverse Event
    Malfunction ·MOOG MEDICAL DEVICES GROUP·Product code FRN·June 14, 2013

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·August 4, 2011

    RESTORE ADVANCED RECHARGEABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·September 26, 2008

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems·October 10, 2018