BEUDAMED
    12 results · 24ms · Sources: EU EUDAMED, US FDA

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    ELECTROSURGICAL PENCIL

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

    Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extendable Pencils, 510(k) #K936304, Model Number: 75820. The device is packaged in a sterile Tyvek peel pouch within a cardboard box which contains 24 pouches per box. Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures.

    FDA Enforcement
    Class II ·Terminated·PSC Industries Inc·July 18, 2012

    Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils, 510(k)#K936304, Model Number: 75800. The device is packaged in a sterile Tyvek peel pouch within a cardboard box. The cartons contain 25 pouches per box. Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures.

    FDA Enforcement
    Class II ·Terminated·PSC Industries Inc·July 18, 2012

    Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extendable Pencils, 510(k) #K936304, Model Number: 75820. The device is packaged in a sterile Tyvek peel pouch within a cardboard box which contains 24 pouches per box. Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures.

    FDA Recall
    Terminated ·PSC Industries Inc·Product code GEI·June 5, 2012

    Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils, 510(k)#K936304, Model Number: 75800. The device is packaged in a sterile Tyvek peel pouch within a cardboard box. The cartons contain 25 pouches per box. Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures.

    FDA Recall
    Terminated ·PSC Industries Inc·Product code GEI·June 5, 2012

    SIC invent Dental Implant Systems

    FDA UDI
    SIC invent AG·ESIC9363041·SIC Standard Abutment Ø 4.2 mm, anterior, 25° a...

    SIC invent Dental Implant Systems

    FDA UDI
    SIC invent AG·04260516873536·SIC Standard Abutment Ø 4.2 mm, anterior, 25° a...

    BACTEC PEDS PLUS/F

    FDA 510(k)
    FDA Class 1 ·Microbiology

    COBAS CORE FSH EIA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    INTEGRATED APD SET W/CASSETTE3-PRONG

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·December 22, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 30, 2013

    DLT TS CER HD 12/14 28MM +12

    FDA Adverse Event
    Injury ·DEPUY IRELAND 9616671·Product code LZO·July 15, 2014