BEUDAMED
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    GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BOSS-2000-2 VACUUM ERECTION DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 17, 2025

    COLUMBUS UCR TIBIAL PLATEAU CEMENTED T2+

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code JHW·July 24, 2015

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 17, 2013

    INTERLINK CONTINU-FLO SOLN SET2 INJ SITES 10 DPM

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·April 19, 2011

    HALL SURGICAL BUR GUARD

    FDA Adverse Event
    Malfunction ·CONMED LINVATEC·Product code DZI·June 16, 2008

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015