BEUDAMED
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    ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    eSensor® XT-8

    FDA UDI
    GENMARK DIAGNOSTICS, INC.·00857167005146·eSensor® Cystic Fibrosis Genotyping Test Cartri...

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·00843717108764·Midway Select Expro 23/CP11 Double End Color Co...

    EECP THERAPY SYSTEM, MODEL TS3

    FDA Adverse Event
    Injury ·VASOMEDICAL, INC.·Product code DRN·December 30, 2002

    LUER ACCESS UNIVERSAL VIAL ADAPTER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    COPELAND MB RESURFACING HUMERAL HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONTOUR

    FDA Adverse Event
    Injury ·BAYER HEALTHCARE, LLC·Product code NBW·April 30, 2010

    BAXANO IO-FLEX MICROBLADE SHAVER

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·March 21, 2013

    SWAN-GANZ, VIP

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DYG·March 7, 2011

    PUMP MMT-512LNAS PRDGM INS SK EN US LN

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·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