BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    Precice™ Max System and Precice™ Ankle Salvage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Novo Surgical

    FDA UDI
    NOVO SURGICAL, INC.·G586C2616510·novo titanium bulldog clamps, lightweight, corr...

    FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Eclipse PRO

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·September 20, 2011

    SENSOR ENLITE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·November 19, 2014

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·August 2, 2013

    TRANSPAC¿ IV TRIFURCATED MONITORING KIT 60 INCH, 3 DISPOSABLE TRANSDUCERS, 3 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42590-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016