BEUDAMED
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    ECHELON MICRO CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Trocar

    FDA UDI
    SOPRO-COMEG GmbH·04059082005010·

    BR2000 BLADES

    FDA UDI
    Peter Brasseler Holdings, LLC·00887919739036·K5-1990-35

    BR2000 BLADES

    FDA UDI
    Peter Brasseler Holdings, LLC·00887919100232·K5-1990-50

    GALT MEDICAL GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OCU-GUARD

    FDA Adverse Event
    Injury ·BIO-VASCULAR, INC.·Product code MTZ·August 16, 1999

    ENDOTAK ENDURANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·April 12, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 11, 2013

    ONE TOUCH ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·May 21, 2008

    FT4, FREE THYROXINE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CEC·September 30, 2016

    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