BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    NOBELACTIVE INTERNAL RP 4.3X8.5MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·August 17, 2020

    NOBELACTIVE INTERNAL NP 3.5X8.5MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·September 9, 2020

    NOBELACTIVE INTERNAL NP 3.5X8.5MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·September 9, 2020

    NOBELACTIVE INTERNAL RP 4.3X8.5MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·August 17, 2020

    NOBELACTIVE 8.5 MM & 18.0 MM

    FDA 510(k)
    FDA Class 2 ·Dental

    Harvard Restore C3

    FDA UDI
    Harvard Dental International GmbH·EHAR70832051·Light cure universal microhybrid composite

    MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRANSFX ANGLED RODS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 9, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 9, 2025

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·April 29, 2013

    3M RED DOT NEONATAL MONITORING ELECTRODES

    FDA Adverse Event
    Malfunction ·3M HEALTH CARE·Product code DRX·April 13, 2011

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·July 24, 2008

    Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925674335.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DPS·March 16, 2005

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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

    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