BEUDAMED
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    QUIK-CHECK OVULATION PREDICTOR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890122520·Zirlux UCLA Plastic Abutment, Non-Engaging, com...

    TO BE ASSIGNED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033399866·

    POSSIS SUTURELESS MYOCARDIAL LEAD

    FDA Adverse Event
    Injury ·POSSIS MEDICAL INC.·Product code FSA·August 9, 1995

    EUB-6000 DIAGNOSTIC ULTRASOUND SCANNER SP-711 SONOPROBE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MAGNUM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    EON

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 12, 2013

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 30, 2014

    SUPERDIMENSION IN REACH BRONCHUS SYSTEM (SDBS)

    FDA Adverse Event
    Malfunction ·SUPERDIMENSION INC.·Product code JAK·February 2, 2011

    SULOX-HD 32 M 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·April 23, 2019

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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