BEUDAMED
    13 results · 28ms · Sources: EU EUDAMED, US FDA

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    AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    VasCure for Carotid Repair

    FDA UDI
    Elutia Med LLC·00859389005089·VasCure for Carotid Repair is indicated for use...

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613060275·Cottle Chisel, 6mm Blade, Square Diamond Knurle...

    OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6 PSOTERIOR-STABILIZING, CEMENTED FEMORAL COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CLEARMEDICAL/KENDALL KNEE-HIGH SCD SLEEVES, CLEARMEDICAL/KENDALL THIGH-HIGH SCD SLEEVES, MEDIUM,SMALL, LARGE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 27, 2025

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 23, 2013

    DEXTRUS 4135

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·April 22, 2011

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008

    CORMATRIX ECM FOR CAROTID REPAIR

    FDA Adverse Event
    Injury ·AZIYO BIOLOGICS INC.·Product code DXZ·October 27, 2020

    VASCURE FOR CAROTID REPAIR

    FDA Adverse Event
    Injury ·ELUTIA INC.·Product code DXZ·August 30, 2024

    METRx II Tube, 16mm x 3cm stainless steel tubular retractor, Part No. 9569670

    FDA Recall
    Terminated ·Medtronic Sofamor Danek Instrument Manufacturing·Product code LXH·January 25, 2006

    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