BEUDAMED
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    exCellerator Cervical Collection Device

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

    Bernafon

    FDA UDI
    Bernafon AG·05711584076729·AQ CO9 B 105, 2.4G NFM DPB COBR ACCUQ

    I-STAT 6+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·June 20, 2019

    CLEVER CHOICE VOICE+ BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV

    FDA 510(k)
    FDA Class 2 ·Microbiology

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 21, 2013

    SECURE 3 MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·June 22, 2011

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 22, 2008

    GMK-HINGE FIXED TIBIAL TRAY SIZE 4 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·April 7, 2020

    bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o, REF 378235 (b) Straight 22.5o, REF 378236 (c) Straight 30o, REF 378237 (d) Straight 45o, REF 378238 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018

    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