BEUDAMED
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    GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776079161·Poole Suction Tube, Curved End

    pen probe cable package

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904090061·

    SYNTHES RESORBABLE CONTOURABLE MESH

    FDA 510(k)
    FDA Class 2 ·Dental

    MAROSIS PACS

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 21, 2025

    CASSETTE MEDI RESERVOIR

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code LHI·October 7, 2021

    CASSETTE MEDICATION RESERVOIR

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code LHI·December 20, 2022

    GREENLIGHT HPS BPH FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS·Product code GEX·April 4, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 25, 2011

    SELUTE PICOTIP

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

    CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·October 30, 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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013