BEUDAMED
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    THE BIOPLATE BATTERY POWERED DRILL

    FDA 510(k)
    FDA Class 2 ·Neurology

    BIPOLAR IRRIGATION FORCEPS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    HEARTMATE II LVAS, EUROPE

    FDA Adverse Event
    Malfunction ·THORATEC CORP.·Product code DSQ·March 21, 2013

    TERUMO CENTRIFUGAL SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWA·February 24, 2011

    CAPTURE-R READY-SCREEN 3 TEST WELLS

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·April 3, 2008

    BD VENFLON PRO SAFETY SAFETY VENOUS INDWELLING CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·October 18, 2022

    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

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020