BEUDAMED
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    TBIRD VS/AVS VOLUME VENTILATOR, MODELS 15568, 15570 , LP10 VOLUME VENTILATOR WITH PRESSURE LIMIT MODEL 00-004130, BEAR 3

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set

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

    BANDER URETERAL DIVERSION STENT SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FAD·June 14, 2023

    OT ULTRASMART METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 28, 2013

    TAXUS (R) LIBERTÉ (R)

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·February 8, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·August 5, 2014

    BANDER URETERAL DIVERSION STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·December 17, 2024

    BANDER URETERAL DIVERSION STENT SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FAD·June 16, 2022

    BANDER URETERAL DIVERSION STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·July 11, 2024

    ARCHITECT C16000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·May 10, 2019

    BANDER URETERAL DIVERSION STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·July 8, 2022

    BANDER URETERAL DIVERSION STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·March 19, 2024

    BANDER URETERAL DIVERSION STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·October 8, 2024

    BANDER URETERAL DIVERSION STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·January 28, 2021

    BANDER URETERAL DIVERSION STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·January 28, 2022

    DRETLER UNIVERSAL URETEROSCOPY STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·February 22, 2022

    BANDER URETERAL DIVERSION STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·February 9, 2022

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM AIRE-CUF , Product Code/List Number/Item Code 65P030; c) PAED, TRACHEOSTOMY TUBE 3.5mm AIRE-CUF , Product Code/List Number/Item Code 65P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM AIRE-CUF , Product Code/List Number/Item Code 65P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM AIRE-CUF , Product Code/List Number/Item Code 65P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM AIRE-CUF , Product Code/List Number/Item Code 65P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM AIRE-CUF , Product Code/List Number/Item Code 65P055;

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

    OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·June 26, 2024