BEUDAMED
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    WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A08

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 8, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 3, 2026

    GRAFTYS HBS (510K NUMBER: K082498)

    FDA Adverse Event
    Injury ·GRAFTYS·Product code MQV·July 11, 2013

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    FDA Adverse Event
    Injury ·OGDEN MFG·Product code KDI·April 25, 2013

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 10, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·July 25, 2008

    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