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    UREA NITROGEN (BUN) LIQUID REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040011140·Zirlux 16+ White 100X25

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526189751·LEVAMED ACTIVE ANKLE SUP BLACK L VI

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526189812·LEVAMED ACTIVE ANKLE SUP BLACK R VI

    CONTACT DETACH

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A DE C.V·Product code FPA·May 1, 2026

    TI TITAMAX IMPLANT (4.1)4.0X11

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·May 2, 2018

    I-STAT

    FDA Adverse Event
    Malfunction ·I-STAT·Product code CHL·February 19, 2002

    LIFERX

    FDA 510(k)
    FDA Class 2 ·Radiology

    RUSCH BRONCHUS BLOCKER KIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 16, 2007

    STANDARD LEAD

    FDA Adverse Event
    Injury ·NEURO - VILLALBA·Product code LGW·March 19, 2013

    CENTRA BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·February 14, 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

    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

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022