BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    LIAISON Vitamin B12

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Bernafon

    FDA UDI
    Bernafon AG·05711584087381·ZR1, KIT 312 NFM R BE ZERENA 1

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776200022·LLETZ AUVARD SP LBS ET

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471122819·K-WIRE - DOUBLE TROCAR 0.6mm DIA x 100mm

    SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD FACS SAMPLE PREP ASSISTANT III (SPA III)

    FDA 510(k)
    FDA Class 2 ·Hematology

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·October 16, 2020

    RESTORE PRIME ADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 7, 2008

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 20, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020