BEUDAMED
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    AXILLOBIFEMORAL GORE-TEX VASCULAR GRAFT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Map-iT

    FDA UDI
    ACCESS POINT TECHNOLOGIES, INC.·00818087020022·Steerable Decapolar PV Catheter, Pulmonary Vein 12

    Stern EX Acid Etched Implant RP 3.75x10.0mm, Direct Delivery, Ti

    FDA UDI
    STERNGOLD DENTAL LLC·00841549108822·The Sterngold Acid Etch Dental Implant System c...

    TAMPONS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)

    FDA 510(k)
    FDA Class 2 ·Neurology

    CLAW GRASP/EXTR FCOS 2X3T 10MM

    FDA Adverse Event
    Malfunction ·INTEGRA YORK, PA INC.·Product code GCJ·May 6, 2014

    LINOX SMART S 75

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVY·January 2, 2013

    NEUROMONITOR BASIC KIT

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC.·Product code GWM·November 12, 2010

    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

    The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·April 10, 2019