BEUDAMED
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    SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ADD-ON CONDYLE

    FDA 510(k)
    FDA Class 2 ·Dental

    CYNOSURE PHOTOGENICA ER

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

    COGNIS

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 11, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 15, 2011

    PROFEMUR MODULAR FEMORAL NECK

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LWJ·May 20, 2008

    MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code KRH·October 26, 2021

    ACRYLOC GHV 20G

    FDA Adverse Event
    Malfunction ·DEPUY CMW REG. # 9610921·Product code LOD·May 27, 2014

    BIOMET FINNED PRI STEM 40MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·July 31, 2017

    VANGUARD CR POR FEMORAL-RT 62.5

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·July 31, 2017

    E1 VANGUARD CRL TIBIAL BEARING 71/75X12

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·July 31, 2017

    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