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

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    PROXIS SYSTEM, MODEL EPS101

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sprint®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70606511·Sprint II Brackets Roth .022" 20 Brackets

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 11, 2018

    DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    AT HOME DRUG TEST, MODEL 9133 T

    FDA 510(k)
    FDA Unclassified ·Unknown

    BD SYRINGE 1ML LL BNS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 13, 2024

    TERUMO CENTRIFUGAL SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DWA·April 5, 2013

    ALARIS PUMP MODULE IV ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP.·Product code FPA·April 8, 2011

    RESTORE ADVANCED RECHARGEABLE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 13, 2008

    Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·November 20, 2013

    Applied Medical's Inzii 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·October 21, 2013

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3598, and 3599. Product Usage: Incubators are designed to maintain an optimal environment for the incubation of tissue and cell samples. These models are designed to maintain temperature, carbon dioxide, and humidity levels.

    FDA Enforcement
    Class II ·Terminated·Thermo Fisher Scientific (Asheville) LLC·April 17, 2013