BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    Sensilight Pro / Pistol IPL

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

    Padded Arm Sling

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357832606·

    AGILE NAIL

    FDA UDI
    ORTHOFIX SRL·18056099649636·CANNULATED AWL

    DASH Flex 12 Centrifuge, Boekel

    FDA UDI
    DRUCKER DIAGNOSTICS·00810052863665·General purpose laboratory centrifuge for sampl...

    VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    MICROMAX-PLUS MOTOR ASSY

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code ERL·October 17, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 21, 2013

    ECHELON*FLEX60 LONG

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 28, 2011

    MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components include femoral, tibial, and patellar components.

    FDA Enforcement
    Class III ·Terminated·Biomet, Inc.·June 17, 2015

    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