BEUDAMED
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    FRESENIUS ICARE MONITORING SYSTEM

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

    AOS ANTI-ROTATION SCREW 5.0mm x 60mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665019841·

    AOS CLAVICLE PLATE, MIDSHAFT SUPERIOR 6 HOLE STRAIGHT, RIGHT

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665013801·

    Momentum

    FDA UDI
    Ulrich Medical Usa, Inc.·00810076337890·Screw, monoaxial, Ø 10mm, length 60mm, cannulat...

    Reicodent

    FDA UDI
    devemed GmbH·04061644045716·Haemostatic forceps 1x2 | 140 mm "Kocher"; stra...

    Reicodent

    FDA UDI
    devemed GmbH·04061644045723·Haemostatic forceps 1x2 | 140 mm "Kocher" curved

    ASTOFLO

    FDA 510(k)
    FDA Class 2 ·Hematology

    MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT

    FDA 510(k)
    FDA Class 2 ·Dental

    EPOC READER

    FDA Adverse Event
    Malfunction ·EPOCAL INC.·Product code CGL·June 17, 2021

    IUNI G2

    FDA Adverse Event
    Injury ·CONFORMIS, INC.·Product code HSX·March 13, 2013

    INSYNC MAXIMO

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code NIK·March 16, 2011

    INDURA CATHETER

    FDA Adverse Event
    Injury ·RICE CREEK MANUFACTURING·Product code LKK·March 27, 2008

    Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.

    FDA Enforcement
    Class II ·Terminated·SpineFrontier, Inc.·August 14, 2013

    Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.

    FDA Recall
    Terminated ·SpineFrontier, Inc.·Product code HXX·May 10, 2013

    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