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

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    ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NXSTAGE PUREFLOW SOLUTION

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

    SPECIAL PROCEDURES HEAD COIL; MODEL # 1100GE-64

    FDA 510(k)
    FDA Class 2 ·Radiology

    TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code JEY·March 3, 2017

    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

    TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code DZL·September 6, 2017

    TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code JEY·April 29, 2013

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·May 10, 2011

    STERLING OVER-THE-WIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code DQY·July 28, 2008

    TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code JEY·March 3, 2017

    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