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

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    FUJIFILM Distal End Cap

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    GEN4 DIGITAL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828160230·GEN4 DIGITAL

    GEN4 DIGITAL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828160223·GEN4 DIGITAL

    Needle aspiration and injection

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113615·PERIBULBAR NEEDLE 23GA 32MM

    GEN4 DIGITAL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828158879·GEN4 DIGITAL

    Needle aspiration and injection

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113622·PERIBULBAR NEEDLE 25GA 32MM

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A20302880·20mm H x 30mm W x 28mm L x 8 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A203028150·20mm H x 30mm W x 28mm L x 15 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A203028120·20mm H x 30mm W x 28mm L x 12 degrees ALIF

    DEMETECH NYLON NONABSORBABLE SUTURE

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

    CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 30, 2025

    AGX

    FDA UDI
    Widex A/S·05706069719529·Audigy AGXWU-IP (Clay brown ) Right

    MAVERICK2 MONORAIL PTCA CATHETER

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC·Product code LOX·October 17, 2008

    CAPSUREFIX NOVUS MRI

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·August 11, 2011

    VIPER SINGLE INNER SETSCW

    FDA Adverse Event
    Injury ·DEPUY SYNTHES SPINE·Product code NKB·July 2, 2013

    ETHICON

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAL·April 11, 2026

    Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 62100; DURA 62105 SUBSTITUTE DUREPAIR 3X3IN NCE, 62105; DURA 62106 SUBSTITUTE DUREPAIR 1X3IN NCE, 62106; DURA 62110 SUBSTITUTE DUREPAIR 4X5IN NCE, 62110; DURA 62111 SUBSTITUTE DUREPAIR 1X1IN NCE, 62111; DURA 62158 SUBSTITUTE DUREPAIR 5X8IN NCE, 62158.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neurosurgery·July 26, 2023

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 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 Inc.·July 11, 2018

    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