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

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    PTG-05

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    K140347

    FDA Adverse Event
    Injury ·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 6, 2021

    K140347

    FDA Adverse Event
    Injury ·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 6, 2021

    ANKYLOS C/X IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    SIREMOBIL ISO-C 3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 28, 2025

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·November 25, 2008

    OPTISENSE

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·September 9, 2011

    HEARTSTART XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 8, 2013

    AMPLATZER AMULET

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code NGV·May 20, 2024

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024