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

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    REGER Nebulizer Irrigation Cannula

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

    WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MROZ REVERSE OSMOSIS SYSTEM

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

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 6, 2014

    HIRES 90K

    FDA Adverse Event
    Malfunction ·ADVANCED BIONICS, LLC·Product code MCM·August 22, 2011

    UNKNOWN ASR HEAD

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. ? REG. # 8010379·Product code KXA·July 17, 2013

    KIDS OXYGENATOR D101

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·April 4, 2025

    Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 31622, 31644 Product Description: MEDIHONEY¿ HCS SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel collodial gelling agent. The gelling agent is contained within the dressing mass. The dressing contains 63%, by weight, Leptospermum Honey. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids in autolytic debridement, and allows for non-traumatic removal. This product is an occlusive dressing, and does require a secondary dressing.

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·September 10, 2025

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022