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

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    VITA PM 7 (20 GRAM BOTTLES), VITA PM 7 (50 GRAM BOTTLES)

    FDA 510(k)
    FDA Class 2 ·Dental

    Prodigy Pocket Blood Glucose Monitoring System

    FDA UDI
    Prodigy Diabetes Care, LLC·00384840503625·Prodigy Pocket Blood Glucose Monitoring System ...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450483862·

    MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    ACCU-CHEK COMFORT CURVE TEST STRIP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ERBE

    FDA Adverse Event
    Malfunction ·LEONHARD LANG GMBH·Product code GEI·November 2, 2022

    ULTIMA ACTIVATOR II REUSABLE DRIVE MECH.

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code MWS·April 8, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 1, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·April 4, 2011

    ERBE

    FDA Adverse Event
    Malfunction ·LEONHARD LANG GMBH·Product code GEI·March 8, 2023

    ERBE

    FDA Adverse Event
    Malfunction ·LEONHARD LANG GMBH·Product code GEI·February 18, 2025

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·November 5, 2010

    ERBE

    FDA Adverse Event
    Injury ·LEONHARD LANG GMBH·Product code GEI·July 27, 2022

    Instructions For Use document of the GPS Trackers.

    FDA Enforcement
    Class II ·Terminated·Blue Ortho·November 4, 2020

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024