BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    Tinnitus Sound Generator Module

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    XTRA AUTOTRANSFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    REPROCESSED EXTERNAL FIXATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    FDA Adverse Event
    Malfunction ·CORDIS CORPORATION·Product code NTE·June 21, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

    SOFT TOUCH II

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·September 25, 2008

    XTRA AUTOTRANSFUSION SYSTEM

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code CAC·August 2, 2021

    DEKA MOTUS AY

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·February 18, 2019

    BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·January 13, 2016

    CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.

    FDA Enforcement
    Class II ·Terminated·Cardiovascular Systems Inc·May 31, 2017

    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