BEUDAMED
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    CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518

    FDA 510(k)
    FDA Class 1 ·Hematology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526827905·ACHIMED ACHILLES SUPP BLACK II

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113720·PS-C Insert, Size 5 x 12mm

    SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TORAYSULFONE DIALYZER

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

    OPT SLEEVE 12X100 STABILITY

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·September 24, 2019

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON)·Product code FTL·March 20, 2013

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·February 15, 2011

    GUIDANT VASO VIEW HEMOPRO

    FDA Adverse Event
    Injury ·GUIDANT CARDIAC SURGERY·Product code GEI·March 31, 2008

    Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.

    FDA Enforcement
    Class II ·Terminated·C.R. Bard, Inc.·September 21, 2016

    CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    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