BEUDAMED
    10 results · 23ms · Sources: EU EUDAMED, US FDA

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    NanoKnife Generator (H78720300351US0)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    KARL STORZ Metal Sterilization Trays

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SIMPLEX P SPEEDSET BONE CEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE GMBH·Product code NBW·January 25, 2019

    GLUCOMETER ELITE 4 BASIC

    FDA Adverse Event
    Other ·ARKRAY, INC·Product code NBW·June 6, 2002

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 7, 2014

    ROCKERSWITCH PENCIL

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·August 3, 2011

    COULTER® LH 750 HEMATOLOGY ANALYXZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·July 29, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 14, 2014

    Transpac¿ IV Monitoring Kit, 60", Disposable Transducer, 3 ml Squeeze Flush Device, Macrodrip, Item No. 42584-05 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