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    DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES

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

    Endo Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964151804·Endo Carry-on Procedure Kit contains Intercept ...

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613153170624·Drill for 12mm Screws, Dental Shaft

    Single Use Biliary Stent V

    FDA UDI
    OLYMPUS MEDICAL SYSTEMS CORP.·04953170185793·Single Use Biliary Stent V

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0100120·Counter Torque, Offset

    JAW INS. BULLET NOSE GRASPER 5MM 310MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code GEI·January 13, 2015

    3D ACTIVETRAC

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PORTABLE INTENSIVE CARE UNIT, MODEL PIC

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MARYLAND GSP.FORCEPS FEN.5/310MM HF CON.

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code GEI·February 19, 2014

    LASSO® NAV CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·March 19, 2013

    COLLEAGUE 3 CXE VOLUMETRICINFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 8, 2011

    RIATA ACTIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008

    uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

    FDA Enforcement
    Class II ·Terminated·Ulrich Medical USA Inc·May 3, 2017

    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

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019