BEUDAMED
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    ITI DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743458·LEVAMED ANKLE SUPPORT SILVER I

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890102910·Zirlux Bite Ver Cyl Eng

    Dornier MedTech

    FDA UDI
    Dornier MedTech GmbH·04049958001741·400 Micron Disposable Diode Laser Lightguide, 0...

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0102110·Shaver, Open 11mm

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023949·PADDLE SPREADER, 11MM

    EEG WITH VIDEO, MODEL EX-NW

    FDA 510(k)
    FDA Class 2 ·Neurology

    MFCD 118

    FDA 510(k)
    FDA Class 2 ·Radiology

    MINIMED QUICK-SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 18, 2025

    MINIMED QUICK-SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 6, 2025

    AXSYM DIGOXIN III

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007

    DUROM ACETABULAR COMPONENT 58/52 CODE R

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·March 14, 2013

    CAREASSIST BED

    FDA Adverse Event
    Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·March 1, 2011

    M2A MAGNUM PF CUP 58MM O.D. X 52MM I.D.

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 11, 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

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015