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

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    Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve

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

    VERSANT SPLENDOR

    FDA UDI
    FGX INTERNATIONAL INC.·00193033308103·

    INTCO TAB ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DISCOVERY MR750W 3.0T

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MDB·January 22, 2025

    ISOFLEX S

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC, CRMD·Product code NVN·January 13, 2014

    ANTERIOR CERVICAL PLATE ASSEMBLY, 2 - LEVEL, 37MM

    FDA Adverse Event
    Malfunction ·ALPHATEC SPINE INC·Product code KWQ·June 27, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 26, 2011

    Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The use of external devices provides the surgeon with a means of bone fixation for the management of fracture and reconstructive surgery. These devices are intended only to assist healing and are not intended to replace normal bone structures. External fixation devices are intended to hold fractured bone surfaces in apposition to facilitate normal healing. While proven successful, the devices are manufactured from metal, plastic, and composite materials. No such fracture fixation device, subject to fatigue, can be expected to withstand activity levels in the same way as would a normal health bone. The external fixation system, therefore, will not be as strong, reliable or durable as a normal human bone.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·November 14, 2012