BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    CuattroDR

    FDA 510(k)
    FDA Class 2 ·Radiology

    COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HYBRID TROCAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SEALING UNIT FROM 5MM TROCARS

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO KG·Product code GCJ·June 17, 2015

    REDUCING CONVERTER 10/12MM TO 5MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO KG·Product code GCJ·June 17, 2015

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 10, 2014

    LC PCA NEW 802.11 AB

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code MEA·June 3, 2013

    OCTRODE LEAD, 60CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 23, 2011

    KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installed diagnostic x-ray system composed of 3 main components: an operator console, U-Arm assembly with x-ray tube including a collimator, and a stationary generator.

    FDA Enforcement
    Class II ·Terminated·Carestream Health Inc.·August 13, 2014

    KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installed diagnostic x-ray system composed of 3 main components: an operator console, U-Arm assembly with x-ray tube including a collimator, and a stationary generator.

    FDA Recall
    Terminated ·Carestream Health Inc.·Product code KPR·May 30, 2014

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014