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

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    ODYSSEY TAN 2000

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

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180173934·STEVENS TENOTOMY, 14CM, CRVD, BLUNT

    SeaSpine® Spacer System - Redondo

    FDA UDI
    Seaspine Orthopedics Corporation·10889981091576·Redondo Rasp, 26mm x 24mm x 14mm, 5 Deg Lordotic

    HEARTLINE TRANSTELEPHONIC ECG RECEIVING CONSOLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HYDRA FITNESS MODEL 311 TOTAL POWER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    OT VERIO IQ METER

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

    SYMPHONY

    FDA Adverse Event
    Injury ·SORIN CRM·Product code NVZ·December 15, 2010

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 15, 2014

    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