BEUDAMED
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    VISULIZE FACTOR IX ANTIGEN KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0310540·T-Handle, Primal, 1/4 inch Square, Cannulated

    EXPLANT™

    FDA UDI
    ZIMMER TRABECULAR METAL TECHNOLOGY INC.·00889024311701·

    RADS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER

    FDA 510(k)
    FDA Class 2 ·Radiology

    COLORADO 2 SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·January 22, 2009

    COLORADO 2 SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·February 23, 2012

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·April 10, 2013

    XACT CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR GALWAY·Product code NIM·May 22, 2008

    NEXGEN PROLONG CR ARTICULAR SURFACE

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code JWH·April 5, 2011

    Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of Ultra Sensitive, Flavors and Colors, Skyn, Thryll, Thyn, and Ultra Thin. UPC 0-70907-02625-0.

    FDA Recall
    Terminated ·Ansell Healthcare Products LLC·Product code HIS·November 5, 2012

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 24, 2016

    ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code DXE·October 19, 2020

    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