BEUDAMED
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    REPROCESSED EXTERNAL FIXATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 14, 2013

    IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SECURE RELINE/PICKUP MATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·July 13, 2018

    12MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HSB·April 29, 2013

    MESH - COMPOSIX KUGEL

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·July 24, 2008

    ATRICLIP GILLINOV-COSGROVE LAA EXCLUSION SYSTEM

    FDA Adverse Event
    Injury ·ATRICURE, INC.·Product code FZP·May 9, 2011

    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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012