BEUDAMED
    11 results · 28ms · Sources: EU EUDAMED, US FDA

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    HYDROMARK BIOPSY SITE MARKER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    KSEA MANHES PNEUMOTROCAR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PROSPACE PEEK IMPLANT 5 7X8X22MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code MAX·June 21, 2013

    TSPACE PEEK IMPLANT 26X11X7MM

    FDA Adverse Event
    Malfunction ·AESCULAP IMPLANT SYSTEMS·Product code MAX·October 30, 2015

    5.0 CM SHORT ATTACHMENT

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·April 5, 2013

    STERRAD NX STERILIZER

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·June 12, 2008

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·April 8, 2011

    EXPERT A2FN NAIL Ø12 R CANN L420 TAN LIG

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code JDS·March 15, 2017

    Contour¿ next GEN Blood Glucose Monitoring System

    FDA Enforcement
    Class II ·Ongoing·Ascensia Diabetes Care US, Inc.·July 26, 2023

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018