BEUDAMED
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    SEER LIGHT COMPACT DIGITAL HOLTER RECORDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BUSCH®, BNA®

    FDA UDI
    BUSCH & CO. GmbH & Co. KG·D8120214701·Carbide, round, bone cutter

    E-Z LINK CROSS CONNECTOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SDI SB OFFICE, MODEL 29-

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·March 26, 2013

    ULTRA (TM) 4-WAY STOPCOCK W/SWIVEL MALE LUER LOCK

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL·Product code FMG·March 7, 2011

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 29, 2007

    M2A-MAGNUM PF CUP 48ODX42ID

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·December 3, 2018

    BD PRECISIONGLIDE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·April 8, 2021

    NEEDLE 30X1/2 RB

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·June 29, 2021

    BD PRECISIONGLIDE¿ NEEDLES

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·March 13, 2023

    PT GRAPHIX (TM)

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·September 6, 2011

    BD PRECISIONGLIDE¿ NEEDLES

    FDA Adverse Event
    Injury ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·May 31, 2023

    NDLE 25GA 7/8IN ECG BLT NO-ANL TRANS ORN

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·February 18, 2019

    BD PRECISIONGLIDE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·July 31, 2019

    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

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015