BEUDAMED
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    I-FLOW ELASTOMERIC PUMP WITH BOLUS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Commonwealth Edison - Burn Bag

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588233185·Commonwealth Edison - Burn Bag

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 4, 2019

    ACTICHROME HEPARIN (ANTI-FXA), MODEL 832

    FDA 510(k)
    FDA Class 2 ·Hematology

    PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·February 28, 2013

    PENUMBRA SYSTEM 032

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code NRY·February 15, 2011

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code KDI·April 1, 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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024