BEUDAMED
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    GC FUJI FIL LC

    FDA 510(k)
    FDA Class 2 ·Dental

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B58210514270·

    MBI PD-103 SL; MBI PD-103 SH

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 10, 2013

    POLYFLUX LR CAPILLARY DIALYZER

    FDA Adverse Event
    Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code MSF·May 20, 2008

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014