BEUDAMED
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    OMNI Surgical System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Critical Cover

    FDA UDI
    Alpha Pro Tech, Inc.·10817583023206·Scrub Shirt, AlphaGuard, Dark Blue, Long Sleeve...

    ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID ABUTMENT, RETENTIVE

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDONIC CA620/530 HEMATOLOGY ANALYZER

    FDA 510(k)
    FDA Class 2 ·Hematology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 11, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    GLIDEWELL HT IMPLANT Ø3.5 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·January 29, 2026

    GLIDEWELL HT IMPLANT Ø3.5 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 20, 2026

    ALVEOLUS "AERO"

    FDA Adverse Event
    Death ·ALVEOLUS·Product code JCT·November 13, 2008

    UNKNOWN DEPUY ENDURANCE CEMENT

    FDA Adverse Event
    Injury ·DEPUY CMW·Product code LOD·August 18, 2011

    PARIETEX UGYTEX PP 15X10CM X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·July 8, 2013

    GLUCOSE SENSOR FREESTYLE LIBRE 2

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC.·Product code MDS·January 19, 2022

    UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014