BEUDAMED
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    ADVANTAGE WORKSTATION 4.1

    FDA 510(k)
    FDA Class 2 ·Radiology

    APC™ PLUS Unitek™ Mini Uni-Twin

    FDA UDI
    3M UNITEK CORPORATION·00652221093103·Mini Uni-Twin(TM) Bracket APC(TM) PLUS LR3 7T/5...

    APC™ II Unitek™ Mini Uni-Twin

    FDA UDI
    3M UNITEK CORPORATION·00652221062086·Mini Uni-Twin(TM) Bracket APC(TM) II LR3 7T/5A ...

    3M™ Unitek™ Uni-Twin™

    FDA UDI
    3M UNITEK CORPORATION·00652221016171·Mini Uni-Twin(TM) Bracket LR3 7T/5A Hk .018 5/Pk

    POWER 5000 GENERAL PURPOSE COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    RANDOX ALBUMIN

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UNKNOWN EEA

    FDA Adverse Event
    Injury ·US SURGICAL PUERTO RICO·Product code GDW·January 12, 2021

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 26, 2013

    BONESOURCE, 2.5G PACK

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS LIMERICK·Product code MQV·February 16, 2011

    DEXTRUS 4135

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO.·Product code DTB·March 28, 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