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

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    Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111094903·SKLARCUT METZ LAHEY STR 4 1/2"

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·February 20, 2020

    APNEARX

    FDA 510(k)
    FDA Class 2 ·Dental

    AGILITY LP TOTAL ANKLE PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FORMATK MAGMA PLATFORM LASER

    FDA Adverse Event
    Injury ·FORMATK SYSTEMS LTD.·Product code GEX·December 19, 2019

    FORMATK MAGMA PLATFORM

    FDA Adverse Event
    Malfunction ·FOMATK SYSTEMS, LTD·Product code GEX·January 8, 2020

    RIATA ST ACTIVE FIXATION

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

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code LWP·June 8, 2013

    CONTAK RENEWAL

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 7, 2011

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·July 28, 2019

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    FDA Adverse Event
    Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·March 22, 2020

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code NKB·October 18, 2017

    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