BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    LipiScan Dynamic Meibomian Imager

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SYMBIA, VERSION 4.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    MIXED MEDIA MARKER

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

    SYMBIA T-SERIES

    FDA Adverse Event
    Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·September 20, 2013

    E.CAM, SYMBIA E, SYMBIA S, SYMBIA T SERIES

    FDA Adverse Event
    Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·May 31, 2013

    E.CAM, SYMBIA E, SYMBIA S, SYMBIA T SERIES

    FDA Adverse Event
    Injury ·SIMENS MEDICAL SOLUTIONS, USA, INC. MI GROUP·Product code KPS·August 3, 2012

    E.CAM, SYMBIA E

    FDA Adverse Event
    Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·July 13, 2012

    E.CAM, SYMBIA E

    FDA Adverse Event
    Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code KPS·May 16, 2013

    E.COM, SYMBIA E

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code IYX·March 15, 2012

    E.CAM

    FDA Adverse Event
    Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP·Product code KPS·January 7, 2014

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 17, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 14, 2013

    OT PING METER

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

    E.CAM, SYMBIA E

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code KPS·April 16, 2013

    COMPREHENSIVE SHOULDER SYSTEM NANO HUMERAL COMP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSD·September 26, 2023

    COMPR NANO HMRL PPS 34MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·June 10, 2024

    COMPREHENSIVE SHOULDER SYSTEM NANO NUMERAL COMPONENT 30 MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSD·March 21, 2024

    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