BEUDAMED
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    MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002199·artVeneer life lower posteriors, XS, BL4

    SoftTip® large

    FDA UDI
    Honeywell Healthcare Solutions GmbH·04036616009898·SoftTip® large R-3211-12 MySign® FDA

    CORTEK MINI LAPAROSCOPE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP

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

    Clarius Ultrasound Scanner

    FDA UDI
    Clarius Mobile Health Corp·07540205001103·Clarius charger

    Clarius Ultrasound Scanner

    FDA UDI
    Clarius Mobile Health Corp·07540205001226·Portable Ultrasound Scanner

    UNOMETER 500 - URINEMETERS

    FDA Adverse Event
    Malfunction ·UNOMEDICAL LTD.·Product code FFG·June 10, 2014

    ALLEGRETTO WAVE EYE-Q EXCIMER LASER

    FDA Adverse Event
    Injury ·WAVELIGHT GMBH·Product code LZS·August 13, 2015

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 13, 2013

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016