BEUDAMED
    10 results · 27ms · Sources: EU EUDAMED, US FDA

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    Stethophone

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Intrigue

    FDA UDI
    LANCER ORTHODONTICS, INC.·00817573021956·OPTYC MBT CUS HK 0T +3A 022 LR

    GENERUS® II

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K31551991·GENERUS® II Base Rx 018 UL/5-5 CS HK

    KetoSens BT Blood B-Ketone Monitoring System

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ST104 TRANSPORT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·July 22, 2011

    NATURALYTE

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 17, 2013

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022