BEUDAMED
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    HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DIRECT DRIVE LCA

    FDA Adverse Event
    Other ·APPLIED MEDICAL RESOURCES·Product code GCJ·May 16, 2008

    AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 6, 2025

    COMPLEX HELICAL - 18

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code HCG·April 11, 2013

    PRECISE PRO RX CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIM·April 13, 2011

    HEARTSTREAM XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 28, 2008

    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

    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