BEUDAMED
    13 results · 27ms · Sources: EU EUDAMED, US FDA

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    Arctic Sun Temperature Management System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528102060·1.6 mm X 180 mm Threaded Guide Wire

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00860006434588·Tasso+ convenience kit allows self-collection o...

    NYOrtho APEX CORE Pommel Wheelchair Cushion Foam 16x16x2

    FDA UDI
    N.Y. ORTHOPEDIC USA, INC.·00811677016610·For patients requiring hip positioning, the NYO...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528109984·1.6mm x 180mm Threaded Guide Wire, Sterile, 2 Pk

    DUET SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    VITAL SIGNS MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 10, 2014

    PRIMARY PLUMSET

    FDA Adverse Event
    Malfunction ·HOSPIRA·Product code FPA·June 4, 2013

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·CORDIS NEUROVASCULAR, INC.·Product code NJE·July 14, 2011

    MEDISLIM

    FDA Adverse Event
    Injury ·MEDICREATIONS, LLC·Product code GEX·April 27, 2020

    Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·May 31, 2017

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018