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

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    LENS SPECTACLE NON-CUSTOM (PRESCRIPTION)

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra

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

    BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MAXIMO II CRT-D

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NIK·June 10, 2014

    INTERSTIM

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·October 4, 2010

    ST104 TRANSPORT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·November 2, 2012

    Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    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