BEUDAMED
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    Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    HERACERAM

    FDA 510(k)
    FDA Class 2 ·Dental

    HOVEROUND REHAB SEATING SYSTEM FOR POWER WHEELCHAIRS

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 12, 2016

    CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code LWR·October 16, 2008

    ASKU

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·August 11, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 2, 2013

    Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Multiphor II Electrophoresis System is a versatile modular electrophoresis system for horizontal electrophoresis, isoelectric focusing, 2-D electrophoresis and electrophoretic transfer Note: The Multiphor II Electrophoresis System (Class I) is the platform used with the hemoglobin electrophoresis gel kit ( Class II) sold by PerkinElmer as the Resolve Hemoglobin Kit (K050709: Product code JJN). The RESOLVE Systems Hemoglobin kit (K050709) is designed to separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins by isoelectric focusing.

    FDA Enforcement
    Class II ·Terminated·Perkinelmer Life Sciences, Inc.·July 12, 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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021