BEUDAMED
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    SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BACFIX ROD, UNKNOWN

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code HSB·January 16, 2020

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036076436·

    TUTTNAUER LTD.

    FDA registration
    TUTTNAUER LTD.·5 products·🇮🇱 Israel

    MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RETAIN-SLEEVE LONG F/MATRIX 5.5

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code LXH·April 2, 2013

    COULTER® LH 500 INSTRUMENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·March 26, 2011

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·April 16, 2008

    1.85MM TI MATRIX SCREW SELF-TAPPING/4MM

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code JEY·January 21, 2015

    superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

    FDA Enforcement
    Class II ·Terminated·superDimension, Inc·July 18, 2012

    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. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013