BEUDAMED
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    LID CHAIN EYELID WEIGHTS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074034539·BONE SCREW 7021750 10 DEG ILC 7.5X50 SS

    Phantom Hindfoot TTC/TC Nail System

    FDA UDI
    Paragon 28, Inc.·00889795135827·Phantom ActivCore Nail, 10.0 X 175mm

    Phantom Hindfoot TTC/TC Nail System

    FDA UDI
    Paragon 28, Inc.·00889795097705·Phantom ActivCore Nail, 10.0 X 175mm

    MEDIS 5MP1H QUAD-HEAD MEDICIAL DIAGNOSTIC DISPLAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ADC PEDIATRIC

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·Product code FOZ·August 19, 2021

    SOFTCLIX ® LANCETS

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code FMK·March 26, 2013

    CL NON-DEHP CONTINU-FLO SET10 DPM, 110", 3 CL SITES

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·March 17, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·March 19, 2008

    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    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