BEUDAMED
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    MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH); TRELLIS INFUSION SYSTEM (20CM INFUSION LENGTH)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DW 276 #3

    FDA 510(k)
    FDA Class 2 ·Dental

    BD SYRINGE 10ML LL S/C 200

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 19, 2025

    ENDO SMARTCAP

    FDA Adverse Event
    MEDIVATORS·Product code KOG·February 2, 2015

    GENTLEMAX

    FDA Adverse Event
    Injury ·CANDELA CORP.·Product code GEX·May 1, 2013

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 4, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·May 12, 2011

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015