BEUDAMED
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    EVISION DATA MANAGEMENT SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ASCENT KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BDRV CANN SCW SS P/T DIA4.5X60MM

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code HRS·January 26, 2017

    FREESTYLE FREEDOM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code NBW·October 17, 2016

    BDRV CANN SCW SS P/T DIA4.5X52MM

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code HRS·January 26, 2017

    FREESTYLE FREEDOM LITE

    FDA Adverse Event
    Injury ·Product code NBW·July 2, 2014

    FREESTYLE FREEDOM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·January 27, 2017

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·May 3, 2013

    E-LUMINEXX VASCULAR STENT

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code NIO·August 20, 2014

    QUATTRODE TRIAL LEAD, 60CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 10, 2011

    LINEAR? ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 27, 2025

    FREESTYLE FREEDOM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code NBW·January 18, 2017

    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

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024