BEUDAMED
    9 results · 25ms · Sources: EU EUDAMED, US FDA

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    INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW

    FDA 510(k)
    FDA Class 1 ·General Hospital

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M9403270·

    ULTIMUM EV HEMOSTASIS INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)

    FDA 510(k)
    FDA Unclassified ·Unknown

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·June 19, 2014

    BAKRI TAMPONADE BALLOON CATHETER

    FDA Adverse Event
    Injury ·COOK UROLOGICAL, INC.·Product code KNA·December 17, 2010

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    JUMAO MEDICAL EQUIPMENT·Product code IOR·February 2, 2013

    Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·May 16, 2018

    Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.

    FDA Enforcement
    Class II ·Terminated·Capintec Inc·April 1, 2020