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

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    O-SCAN MR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    EECP THERAPY SYSTEM, MODEL TS3

    FDA Adverse Event
    Injury ·VASOMEDICAL, INC.·Product code DRN·December 30, 2002

    IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)

    FDA 510(k)
    FDA Class 1 ·Dental

    RESORBABLE NO PROFILE SCREW AND WASHER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 18, 2025

    TRIMA ACCEL

    FDA Adverse Event
    Malfunction ·TERUMO BCT·Product code GKT·May 3, 2013

    PROMUS PREMIER?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·September 16, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 2, 2011

    DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST Segment analysis, heart rate (HR) , respiration rate (RESP), temperature (TEMP), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG),impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM).

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·December 19, 2012

    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