BEUDAMED
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    MUCATE AGAR, SLANTS AND MUCATE BROTH

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Infinity ID WaterLock2

    FDA UDI
    Drägerwerk AG & Co. KGaA·04048675249351·

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556709105·GC Initial™ PC Pellets Bleached BO+, 5pcs. X 2

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228720201·GC Initial™ PC Pellets Bleached BO+, 5pcs. X 2

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376680682·Proximity Drill, 20mm

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867311770·Low Profile Screw, 2.0 x 20mm, Cortical

    RESTORATION ADM SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Arlington PLIF/TLIF Cage

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LOW PROFILE SCREW, 2.0 X 18MM, CORTICAL

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code HRS·August 8, 2025

    LOW PROFILE SCREW, 2.0 X 20MM, CORTICAL

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code HRS·August 8, 2025

    PROGRASP FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 13, 2014

    COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 18, 2010

    HUT EXT DR FINAL ASSY-REVERSE

    FDA Adverse Event
    Malfunction ·LIEBEL-FLARSHEIM CO.·Product code IXR·December 11, 2012

    Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 78718 (18 Fr.) and 78720 (20 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae both have clear flexible, thin wall wire-wound PVC bodies with angled, beveled tips. The proximal end of the cannula includes a 3/8" (0.95 cm) vented or non-vented connector with a peel cap. The vented connector allows air to be vented from the cannula before connection to the perfusion line. The Select 3D Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow. The cannula body features a tip orientation line indicating direction of the cannula tip during cannulation. Overall cannula length is 11.5" (29.2 cm). These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·February 26, 2014

    Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 78718 (18 Fr.) and 78720 (20 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae both have clear flexible, thin wall wire-wound PVC bodies with angled, beveled tips. The proximal end of the cannula includes a 3/8" (0.95 cm) vented or non-vented connector with a peel cap. The vented connector allows air to be vented from the cannula before connection to the perfusion line. The Select 3D Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow. The cannula body features a tip orientation line indicating direction of the cannula tip during cannulation. Overall cannula length is 11.5" (29.2 cm). These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Management·Product code DWF·January 30, 2014