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

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    Portable Slit Lamp

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100332·BARRAQUER INFANT WIRE SPECULUM

    BT-350

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

    VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SYRINGE 20ML LL TIP CONV PAK

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·February 20, 2019

    ESON 2 NASAL MASK

    FDA Adverse Event
    Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·August 14, 2019

    FETAL MONITOR/CARDIOTOCOGRAM

    FDA Adverse Event
    Injury ·BISTOS CO., LTD.·Product code HGL·January 29, 2018

    QUADRA ASSURA DR CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·October 8, 2014

    CAPSUREFIX MRI

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·June 8, 2013

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 21, 2011

    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; 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