BEUDAMED
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    AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Harvard RestoreFlow A1

    FDA UDI
    Harvard Dental International GmbH·EHAR70832111·Light cure universal flowable microhybrid compo...

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0132110·Trial, TLIF, 27L OB CRV 7Deg, 11mm

    HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HRS·November 16, 2015

    4.0MM CANCELLOUS BONE SCREW PARTIALLY THREADED/45MM

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HWC·December 9, 2015

    CANNULATED 4.0MM HEXAGONAL SCREWDRIVER

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code HXX·April 29, 2013

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 13, 2011

    BRAVO

    FDA Adverse Event
    Malfunction ·ARIZONA DEVICE MANUFACTURING·Product code FFT·July 24, 2008

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·September 1, 2016

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·December 4, 2015

    4.0MM CANCELLOUS BONE SCREW FULLY THREADED/45MM

    FDA Adverse Event
    Injury ·SYNTHES GRENCHEN·Product code HWC·December 18, 2015

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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