BEUDAMED
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    BACT/ALERT SA CULTURE BOTTLE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    METRX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AU5 ULTRASOUND IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    METRX SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·June 10, 2024

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·March 19, 2013

    SCREW-IN

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 16, 2011

    ONE TOUCH ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·March 27, 2008

    NEEDLE 20GA 1IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·February 20, 2024

    BIODESIGN URETHRAL SLING

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code FTM·July 29, 2013

    Speed Stitch Needle Cassette

    FDA Enforcement
    Class II ·Ongoing·ArthroCare Corporation·September 30, 2020

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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