BEUDAMED
    9 results · 23ms · Sources: EU EUDAMED, US FDA

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    RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CERETENE SOLUBLE IMPLANT MATERIAL

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXYCODONE TEST DEVICE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 29, 2025

    WHEELCHAIR COMPONENTS

    FDA Adverse Event
    JUMAO MEDICAL EQUIPMENT·Product code KNN·May 29, 2013

    LIFESHIELD SECONDARY SET WITH CONV PIN

    FDA Adverse Event
    Malfunction ·HOSPIRA, LTD·Product code FPA·August 22, 2008

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·June 18, 2011

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015