BEUDAMED
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    AART PECTORALIS IMPLANT

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    NA

    FDA UDI
    STERILMED, INC.·10888551021333·BUR CARBIDE CYLINDRICAL 2 FLUTES

    ULTRAPOWER

    FDA UDI
    Conmed Corporation·10845854000809·ULTRAPOWER BUR, ROUND/CYLINDRICAL (LIME), 3 MM

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OYC·March 27, 2018

    DANIELS SHARPSMART REUSABLE SHARPS CONTAINER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)

    FDA 510(k)
    FDA Class 2 ·Hematology

    ADVIA CENTAUR XP HBC TOTAL (HBCT) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LOM·March 26, 2013

    CL MICRO EXT SET W/CL INJ SITE60IN 1.5M LL 0.5ML STERILE NON

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·March 17, 2011

    NEUROTHERM DISPOSABLE RADIOFREQUENCY CANNULA

    FDA Adverse Event
    Malfunction ·NEUROTHERM, INC.·Product code GXI·July 8, 2014

    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