BEUDAMED
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    HbA1c Advanced

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331182884·russian tissue forceps, 16" (40.0 cm)

    ENDOSSEOUS DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ISCREEN VISION SCREENER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    FEMORAL NAIL, A/R T2 FEMUR ? 10X380MM

    FDA Adverse Event
    Injury ·STRYKER TRAUMA GMBH·Product code HSB·August 3, 2012

    FEMORAL NAIL, A/R T2 FEMUR ? 10X360MM

    FDA Adverse Event
    Injury ·STRYKER TRAUMA GMBH·Product code HSB·August 3, 2012

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·July 28, 2011

    AL-III W/FOOT CONTROL

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code GEY·June 21, 2013

    NELLCOR N-550 PULSE OXIMETER

    FDA Adverse Event
    Malfunction ·NELLCOR·Product code DQA·September 24, 2008

    BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·January 13, 2016

    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