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

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    PreOp

    FDA 510(k)
    FDA Class 2 ·Neurology

    B-P TOTAL HIP SYSTEM

    FDA UDI
    ENDOTEC, INC.·00814193023483·B-P HIP SELF-ALIGNING ACETABULAR CUP & BEARING ...

    SYNOVO HIP COMPONENTS

    FDA UDI
    Synovo Production·00814193026163·HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28...

    TC-PLUS PRIMARY KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GENESIS TOUCH SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESTORELLE L

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code OTO·December 9, 2020

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·July 22, 2011

    BLADELESS VP 12MM ST W/ FIXATION

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code GCJ·May 30, 2013

    IAB: 8 FR - 40 CC

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code DSP·September 19, 2008

    HAMMER

    FDA Adverse Event
    Malfunction ·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code LXH·February 11, 2020

    HAMMER

    FDA Adverse Event
    Malfunction ·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code MAX·February 11, 2020

    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

    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018