BEUDAMED
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    PRECEDENCE SPECT/CT IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIOSTEON CROSS PIN

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FLEX-NECK PD CATHETER, INFANT

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

    ACCU-CHEK PERFORMA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 10, 2013

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·September 2, 2014

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Injury ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·April 7, 2011

    ARROW PICC COMPONENT: 3 FR X 21-1/2" (55 CM)

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code LJS·December 4, 2020

    ARROW PI PICC KIT: 2L 5.5FR 55CM AGBA TIPT

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL LLC·Product code LJS·November 15, 2023

    Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    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