BEUDAMED
    16 results · 24ms · Sources: EU EUDAMED, US FDA

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    iBed Wireless with iBed Mobile

    FDA 510(k)
    FDA Class 2 ·General Hospital

    iTero Element Flex

    FDA UDI
    Align Technology, Inc.·00816063020295·Scanner

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113479·MINIATURE BLADE #64 (BX/5)

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112984·CORNEAL TREPHINE BLADE9.5MM

    EU-TTG IGA AND EU-TTG IGG

    FDA 510(k)
    FDA Class 2 ·Immunology

    NEURO II

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    ASKU

    FDA Adverse Event
    Injury ·MEDTRONIC MILACA INC.·Product code DTE·August 11, 2011

    MIDMARK/PROGENY

    FDA Adverse Event
    Malfunction ·QUANTUM MEDICAL IMAGING, LLC.·Product code IZW·September 17, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·July 2, 2013

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·May 26, 2023

    CHLORAPREP ONE STEP HI-LITE ORANGE

    FDA Adverse Event
    Malfunction ·CAREFUSION 213, LLC 0113·Product code KXG·November 1, 2021

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EGS·May 28, 2023

    ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2 REUSABLE, ATAR-MDT2S-A, DK BLUE 30CM REUSABLE, ATAR-MDT2S-V WHITE 30CM REUSABLE, ATAR-MDTL REUSABLE, ATAR-MDTR REUSABLE, ATAR-R REUSABLE, ATAR-R T4P REUSABLE, ATAR-R1 REUSABLE, ATAR-RL REUSABLE, ATAR-T REUSABLE, ATAR-V WHITE REUSABLE, ATAR-V2 REUSABLE, XI.A DARK BLUE REUSABLE, XI.MDT REUSABLE, XI.R REUSABLE, XI.V WHITE, REUSEABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker

    FDA Enforcement
    Class I ·Terminated·Oscor, Inc.·July 19, 2017

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021