BEUDAMED
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    AEROECLIPSE II BREATH ACTUATED NEBULIZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Young

    FDA UDI
    YOUNG DENTAL MANUFACTURING I, LLC·00302730536058·Young Prophy Cup, Latex Free, Soft, Long, Purpl...

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809843927·FOR MEN 30-40 MM HG KNEE HIGH CLOSED TOE EXTRA ...

    SPACELABS MEDICAL MULTIPARAMETER MODULE 91496

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INSCOPE 3-STAGE BALLOON DILATOR

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

    FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code HTO·November 8, 2016

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·April 11, 2013

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·March 17, 2011

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM HYDRO

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·May 23, 2008

    ATRICURE BIPOLAR SYSTEM

    FDA Adverse Event
    Injury ·ATRICURE, INC.·Product code GEI·July 28, 2010

    FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTO·March 20, 2019

    FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code HTO·January 9, 2017

    FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code HTO·October 8, 2015

    COULTER LH 750 Hematology Analyzer.

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code GKZ·December 16, 2004

    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