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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BCC GAMMA CAMERA

    FDA 510(k)
    FDA Class 2 ·Radiology

    REVEAL PLUS INSERTABLE LOOP RECORDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CONTOUR

    FDA Adverse Event
    Injury ·BAYER HEALTHCARE, LLC·Product code NBW·April 30, 2010

    PROFEMUR(R) Z STEM PLASMA SPRAYED

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·March 27, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 15, 2014

    CELL-DYN WBC REAGENT A

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·April 1, 2008

    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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012