BEUDAMED
    20 results · 32ms · Sources: EU EUDAMED, US FDA

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    Medline ReNewal Reprocessed Stryker SERF AS Energy Probes

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

    LYOPHILIZED MULTIBLAST MEDIUM KIT

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SECURMARK BIOPSY SITE MARKING SYSTEM

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

    OPTIPAC 60 REFOB BONE CMT R-3

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·May 11, 2026

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 17, 2013

    MINIARC SLING

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·July 19, 2011

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·September 19, 2008

    BIOMET BONE CMENT R 1X40 JP

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code LOD·May 22, 2025

    REFOBACIN BONE CEMENT R 1X40-3

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code LOD·June 18, 2025

    OPTIPAC 80 BIOMET BC R

    FDA Adverse Event
    Death ·BIOMET FRANCE S.A.R.L.·Product code LOD·April 9, 2026

    BIOMET BONE CEMENT R 40 -3

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code LOD·July 31, 2025

    BIOMET BONE CMENT R 1X40 JP

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code LOD·June 17, 2025

    OPTIPAC 60 REFOB BONE CMT R-3

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·February 5, 2025

    OPTIPAC 60 REFOB BONE CMT R-3

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·February 5, 2025

    BIOMET BONE CMENT R 1X40 JP

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·October 8, 2025

    BIOMET BONE CMENT R 1X40 JP

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·October 8, 2025

    BIOMET BONE CMENT R 1X40 JP

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code LOD·April 8, 2025

    OPTIPAC 80 BIOMET BC R

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·February 21, 2025

    TRULIANT PS CEM FEM PS CEM LEFT SZ 1.5

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·September 30, 2024

    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