BEUDAMED
    12 results · 28ms · Sources: EU EUDAMED, US FDA

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    AvaDent Denture Base Material

    FDA 510(k)
    FDA Class 2 ·Dental

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111098277·SKLCT IRIS SCISS CVD S/S 4 1/2

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100325·INFANT WIRE SPECULUM 4MM BLADE

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100349·FEMTO SPECULUM FLAT WIRE

    SILVERLON CA (CALCIUM ALGINATE)

    FDA 510(k)
    FDA Unclassified ·Unknown

    VINYL EXAMINATION POWDER FREE GLOVES, CLEAR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 7, 2011

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·June 8, 2013

    UNOMETER SAFETI PLUS, 150CM, 1,5L,RH

    FDA Adverse Event
    Malfunction ·UNOMEDICAL LTD·Product code FFG·October 15, 2015

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS45; c) 5.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS50; d) 5.5MM FLEXTEND PEDIATRIC PLUS STRIAGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS55; e) 6.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS60

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024