BEUDAMED
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    TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER

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

    Hospira

    FDA UDI
    ICU Medical, Inc.·10887787007609·LATEX-FREE Y-TYPE BLOOD SET, Nonvented, 80 Inch...

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123045·K-WIRE - DOUBLE TROCAR 0.9mm DIA x 100mm

    SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PREXION 3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·December 9, 2010

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·January 17, 2013

    GRASPING RETRACTOR INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 8, 2014

    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