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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    SELF HEATING DISPOSABLE HEAT PAD

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    AURADONICS

    FDA UDI
    AURADONICS INC.·00810033836305·LATEX ELASTICS 1/4" 2.5 oz. - AMBER, 100000 ea....

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0112060·Tap, 6.50mm

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0112060·Tap, 8.5 mm

    InSePtion MIS Fixation System

    FDA UDI
    Kalitec Direct LLC·B07314K0112060·Punch, 6 and 8 mm

    PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES

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

    TECO DIAGNOSTICS SALIVA ALCOHOL TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 9, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 2, 2015

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023