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

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    Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)

    FDA 510(k)
    FDA Class 2 ·Radiology

    NITREX

    FDA UDI
    Covidien LP·10821684001414·Guidewire

    NITREX™

    FDA UDI
    EV3, INC·00763000185374·GW N180601 NITREX V04

    NITREX

    FDA UDI
    Covidien LP·00821684058138·Guidewire

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486001995·MCK Onlay Tibia Baseplate

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481121401·LOCATOR R-Tx Abutment for 4.2mm Platform Intern...

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481121340·LOCATOR F-Tx Abutment for 4.2mm Platform Intern...

    Halyard

    FDA UDI
    O&M HALYARD, INC.·10680651418064·ACM,CARDIO,SRGDRP,-,MED,5

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·November 7, 2011

    eTRAX™ Needle

    FDA UDI
    CIVCO MEDICAL INSTRUMENTS CO., INC.·00841436103442·Sterile needle, 18GA x 6cm with (7.6 tapered to...

    Vasomedical-Biox™ 1806 ABP Monitor With Analysis S/W

    FDA UDI
    VASOMEDICAL, INC.·00817980020054·Ambulatory Blood Pressure Recorder

    SENTINELLA 102

    FDA 510(k)
    FDA Class 1 ·Radiology

    ERGO++ VERSION 1.7

    FDA 510(k)
    FDA Class 2 ·Radiology

    PERFORATOR DRIVER WITH HUDSON END

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 17, 2014

    TENDRIL SDX

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·June 20, 2013

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 27, 2011

    Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2; Gendex Dental Systems, 901 West Oakton Street, Des Plaines, IL 60018. Intended for use of the software is to control capture, display, treatments, analysis and saving of x-ray digital images.

    FDA Recall
    Terminated ·Gendex Dental Systems·Product code MUH·March 6, 2009

    Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.

    FDA Enforcement
    Class II ·Terminated·Mako Surgical Corporation·March 9, 2016

    Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona¿ Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics for passive kinematic data collection. Single-use, sterile. Packaged in a sterile blister and outer shelf pack. Sold individually. Component: Yes. The Canturio¿ Smart Extension (CSE) is a tibial implant component intended for use with the Zimmer Persona¿ Personalized Knee System.

    FDA Enforcement
    Class II ·Ongoing·Canary Medical, Inc.·July 16, 2025

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019