BEUDAMED
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    AURA CERAMIC DENTAL APPLIANCE

    FDA 510(k)
    FDA Class 1 ·Dental

    ANA/HEp-2 IgG IFA 120 Test

    FDA UDI
    Hemagen Diagnostics, Inc.·G5229023901·For the detection and titration of anti-nuclear...

    QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·June 30, 2014

    LEAD LOCKING DEVICE

    FDA Adverse Event
    Injury ·SPECTRANETICS CORPORATION·Product code DRB·January 8, 2013

    PUMP MMT-723NAL PRDGM INSULIN CLEAR EN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·November 12, 2010

    DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015

    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