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

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    Resolve 2.0

    FDA 510(k)
    FDA Class 2 ·Dental

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517638007·CoRoent Ant TLIF PEEK, 15x12x32mm 12°

    HairCheck-DT (Cocaine)

    FDA UDI
    Quest Diagnostics·00868586000216·HairCheck-DT (Cocaine) is an ELISA test kit use...

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690124269·Modular Offset Stem 13mm x 125mm 2mm

    BARD COLLAMEND IMPLANT, MODELS 1175101, 1175102, 1175103, 1175104, 1175105

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

    STINGRAY CERVICAL CAGE; SHARK IMPLANT (PLIF); BULL SHARK IMPLANT(PLIF); TIGER IMPLANT (TLIF); GREAT WHITE IMPLANTS(ALIF)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    FDA Adverse Event
    Malfunction ·THERAKOS, INC.·Product code LNR·October 3, 2014

    ELECTRODE, PACEMAKER, PERMANENT

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA·Product code DTB·June 7, 2013

    TETRA CXP SYSTEM FOR THE CYTOMICS FC 500 WITH CXP SOFTWARE

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·June 24, 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

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    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