BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    GBR system

    FDA 510(k)
    FDA Class 2 ·Dental

    CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·February 15, 2021

    COE SOFT

    FDA 510(k)
    FDA Class 2 ·Dental

    POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CD HORIZON SPINAL SYSTEM

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

    CD HORIZON SOLERA VOYAGER SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·May 27, 2024

    G7 BISPHERICAL SHELL 52E

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·September 2, 2019

    OPEN SPINE ANGLED CLAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 14, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 21, 2011

    PRECISE OTW NITINOL STENT

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO,·Product code NIM·September 16, 2008

    EAGLE EYE PLATINUM SHORT TIP

    FDA Adverse Event
    Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

    EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER

    FDA Adverse Event
    Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

    EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER

    FDA Adverse Event
    Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

    CD HORIZON® SOLERA® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEDICAL COSTA RICA S.R.L.·Product code KWP·December 30, 2025

    CD HORIZON® SOLERA® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEDICAL COSTA RICA S.R.L.·Product code KWP·June 10, 2025

    TSRH® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEDICAL COSTA RICA S.R.L.·Product code NKB·January 22, 2026

    BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455 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

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020