BEUDAMED
    18 results · 31ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    Arthrex iBalance TKA System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111097737·SKLARCUT METZ SCISS STR B/B 7"

    CD HORIZON SPINAL SYSTEM

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

    SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    IOS FASTSCAN SPRAY

    FDA 510(k)
    FDA Class 2 ·Dental

    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

    MAXIMO II DR

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code LWS·June 8, 2013

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 7, 2011

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 15, 2015

    CD HORIZON SPINAL SYSTEM

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

    MULTIPLE CLIP APPLIER LIGACLIP

    FDA Adverse Event
    Malfunction ·STERILMED, INC.·Product code NMJ·November 22, 2021

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

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

    MULTIPLE CLIP APPLIER LIGACLIP

    FDA Adverse Event
    Malfunction ·STERILMED, INC.·Product code NMJ·November 22, 2021

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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

    ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; 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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012