BEUDAMED
    18 results · 29ms · Sources: EU EUDAMED, US FDA

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    AugMENTA Penile Implant

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ACCUTRAY

    FDA UDI
    MEDICAL ACTION INDUSTRIES INC.·10809160001639·

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·00304040187746·ZIRLUX ML DISC C2 98x18

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112588·BARRON CORNEAL PUNCH 6.75MM

    BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JTW·August 23, 2023

    MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEDICAL ADMINISTRATOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    Widex

    FDA UDI
    Widex A/S·05706069424515·Widex MENU ME-9 BTE (Titan grey ) Telecoil, Vol...

    Widex

    FDA UDI
    Widex A/S·05706069370386·Widex mind220 M2-9 BTE (Titan grey ) Telecoil, ...

    Widex

    FDA UDI
    Widex A/S·05706069689433·Widex BEYOND B-F2 (Titan grey ) Telecoil, RC co...

    STRATA II, ADJUSTABLE DELTA VALVE, SMALL

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROSURGERY·Product code JXG·October 15, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 10, 2011

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·July 1, 2013

    UNKNOWN CAGE/SPACER

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code OVD·May 18, 2021

    Clarius Ultrasound Scanner

    FDA UDI
    Clarius Mobile Health Corp·07540205001004·High-density transducer type - high-frequency l...

    Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.

    FDA Enforcement
    Class II ·Terminated·SynCardia Systems Inc.·January 9, 2013

    Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    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