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

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    FDA 510(k)
    FDA Class 2 ·Neurology

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100532601·IN-OVATION® C Roncone 022/U5-5 L3-3 CS HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100532001·IN-OVATION® C Base Rx 022 U5-5/L3-3

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100532611·IN-OVATION® C Roncone 022/U5-5 L3-3 CS-BC HK

    MYSTIQUE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K110532101·MYSTIQUE® MB RT RX 022 U 5-5/L3-3 CS HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100532111·IN-OVATION® C Base Rx 022 U5-5/L3-3 CS-BC HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100532101·IN-OVATION® C Base Rx 022 U5-5/L3-3 CS HK

    T.E.A.R. TECH3

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MONOJECT

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD·Product code PNR·April 14, 2024

    CARDINAL HEALTH

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 12, 2024

    CARDINAL

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 12, 2024

    INFINION 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 3, 2023

    PD1200 DEFIBRILLATOR/PACEMAKER

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code LDD·October 2, 2008

    THREADED GUIDE WIRE W/ TROCAR TIP, DIA 1.35MM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code MDM·August 4, 2011

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·June 21, 2013

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·June 5, 2019

    CARDINAL HEALTH

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 12, 2024

    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