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

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    Axxent Electronic Brachytherapy System Model 110 XP 1200

    FDA 510(k)
    FDA Class 2 ·Radiology

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111094996·SKLCT METZ LAHEY CVD 5 3/4"

    Ophthalmic Speculum

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

    INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP

    FDA 510(k)
    FDA Unclassified ·Unknown

    TREP-SURE TREPONEMAL ANTIBODY EIA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RIATA ST ACTIVE FIXATION

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

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

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

    ENDOTAK DSP

    FDA Adverse Event
    Injury ·HISTORICAL PUERTO RICO·Product code NVY·July 7, 2011

    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