BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    PMMA BLOCK

    FDA 510(k)
    FDA Class 2 ·Dental

    ULTROID HEMORRHOID MANAGEMENT SYSTEM

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

    Dental Electric Motor

    FDA 510(k)
    FDA Class 1 ·Dental

    ANN BLUNT TIP SCREW 4X44MM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSB·April 29, 2026

    EMERGENCY BONE SCREWS, CROSS-FIT, SELF-TAPPING, DI

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS FRIEBURG·Product code JEY·April 30, 2010

    BONE SCREWS,EMERG,C-F,S-T,1.9X

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS FREIBURG·Product code JEY·April 30, 2010

    DURATA STS OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 12, 2013

    Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026