BEUDAMED
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    TWINKY STAR

    FDA 510(k)
    FDA Class 2 ·Dental

    SEW-EASY®

    FDA UDI
    LSI Solutions, Inc.·00850200006636·SEW-EASY® COMBO KIT, 5mm

    SEW-EASY®

    FDA UDI
    LSI Solutions, Inc.·00850200006490·SEW-EASY® COMBO KIT, 5mm

    CARDINAL HEALTH

    FDA UDI
    Cardinal Health 200, LLC·10885425958092·CIRCUMCISION

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC·Product code QJR·June 16, 2021

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·June 9, 2021

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC·Product code QJR·June 17, 2021

    DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    PULMO-MIST COMPRESSOR MODEL # 4323

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NEWLIFE INTENSITY

    FDA Adverse Event
    Injury ·AIRSEP CORP.·Product code CAW·March 22, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 14, 2014

    ICON MODULAR SPINAL FIXATION SYSTEM

    FDA Adverse Event
    Malfunction ·BLACKSTONE MEDICAL, INC.·Product code MNI·March 28, 2008

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    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

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022