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

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    Dextramer CMV Kit

    FDA 510(k)
    FDA Class 2 ·Hematology

    MODIFICATION TO PHYTACARE ALGINATE HYDROGEL WOUND FILLER

    FDA 510(k)
    FDA Unclassified ·Unknown

    HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939

    FDA 510(k)
    FDA Class 2 ·Microbiology

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

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

    CARELINK

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

    VISTA BASIC SAFETY INFUSION SYSTEM

    FDA Adverse Event
    Malfunction ·B. BRAUN MEDICAL, INC.·Product code FRN·June 20, 2011

    BZO Strip Dip Card (300ng/ml)*, Item No. 100170

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·February 18, 2015

    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