BEUDAMED
    18 results · 29ms · Sources: EU EUDAMED, US FDA

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    NEUROTHERM, MODEL JK4

    FDA 510(k)
    FDA Class 2 ·Neurology

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033275702·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033275658·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033275665·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033275696·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033275672·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033275689·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033275641·

    ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code MEB·September 17, 2021

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code MEB·September 4, 2024

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·May 14, 2018

    MBT CEM KEEL TIB TRAY SZ4

    FDA Adverse Event
    Injury ·9616671 DEPUY IRELAND·Product code NJL·March 19, 2013

    UNK DEPUY ASR HIP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 4, 2011

    DUREPAIR DURA SUBSTITUTE

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROSURGERY·Product code GXQ·March 11, 2008

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b) 3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN030; c) 3.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN035; d) 4.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN040; e) 2.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP025; f) 3.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP030; g) 3.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP035; h) 4.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP040; i) 4.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP045; j) 5.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP050; k) 5.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP055

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    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