BEUDAMED
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    EMIT 2000 VANCOMYCIN CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074027852·BONE SCREW 7020845 ILIAC 8.5X45 SS

    APC™ PLUS Unitek™ Mini Uni-Twin

    FDA UDI
    3M UNITEK CORPORATION·00652221093820·Mini Uni-Twin(TM) Bracket APC(TM) PLUS UL3 0T/1...

    APC™ II Unitek™ Mini Uni-Twin

    FDA UDI
    3M UNITEK CORPORATION·00652221062802·Mini Uni-Twin(TM) Bracket APC(TM) II UL3 0T/11A...

    3M™ Unitek™ Uni-Twin™

    FDA UDI
    3M UNITEK CORPORATION·00652221016904·Mini Uni-Twin(TM) Bracket UL3 0T/11A .018 5/Pk

    MODIFICATION TO JMS A.V. FISTULA NEEDLE SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PAFLUFOCON C AND E DAILY CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 30, 2007

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT·Product code CBK·March 18, 2013

    IGA REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code CZP·March 16, 2011

    VITEK® 2 AST-N350

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·December 17, 2018

    VITEK® 2 AST-N350

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·December 17, 2018

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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