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    PICCOLO PHOSPHORUS TEST SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496022312·WONDER MODEL 140 OPAQUE, SIZE ML, MOKA, GRADUAT...

    MedGyn collection set

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803022312·tubing used during suction curettage

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113584·PS-C Insert, Size 3 x 12mm

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113295·STAB KNIFE 30 DEGREE (BX/5)

    Specials

    FDA UDI
    Seaspine Orthopedics Corporation·10889981157203·Cambria Trial without Depth Stop

    PROTON VISION 7.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ON-Q C-BLOC: 400ML, 2-14ML/HR SELECT-A-FLOW

    FDA Adverse Event
    Injury ·I-FLOW, LLC·Product code MEB·September 7, 2012

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 27, 2013

    ENDOPATH** XCEL* TROCAR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·March 17, 2011

    BROVIAC 4.2 FR S/L CATHETER

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (BASD)·Product code LJS·March 31, 2008

    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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016