BEUDAMED
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    GALILEO CAS/NAV TKR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717102974·Midway Select Disposable Diamonds 847-016C, Pkg/25

    SMR GLENOSPHERE Ø 36MM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWS·November 17, 2021

    SUPER 1

    FDA 510(k)
    FDA Class 2 ·Dental

    ETEST MOXIFLOXACIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    LUX 1440

    FDA Adverse Event
    Malfunction ·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 25, 2013

    FIXODENT DENTURE ADHESIVE, COMPLETE MULTICARE (CALCIUM ZINC GANTREZ SALT 33%, CE

    FDA Adverse Event
    Other ·PROCTER & GAMBLE MANUFACTURING CO.·Product code KOO·March 14, 2011

    MBT CEM TIBIAL TRAY SZ4

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code NJL·March 25, 2008

    EVOLUT PRO PLUS VALVE

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 29, 2022

    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

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    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