BEUDAMED
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    LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119

    FDA 510(k)
    FDA Class 2 ·Immunology

    MAS Urinalysis Liquid Urinalysis Control 1

    FDA UDI
    Microgenics Corporation·00884883004146·

    Vilex Power Accessory

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731122315·KWire .094 x 9" (2.4x225mm)

    SYRINGE 10ML REG PR SALINE 10ML FILL

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·May 30, 2025

    ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BREATHTEK - UBIT UBT FOR H. PYLORI

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·July 10, 2024

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 27, 2013

    PELORIS RAPID TISSUE PROCESSOR

    FDA Adverse Event
    Malfunction ·LEICA BIOSYSTEMS MELBOURNE·Product code IEO·February 23, 2011

    HILL-ROM 100 LOW BED

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·March 27, 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

    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

    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