BEUDAMED
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    AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ORA Implant Abutment 2.0mm Cuff (BH)

    FDA UDI
    STERNGOLD DENTAL LLC·00841549112881·The ORA System is indicated for use with dental...

    ANESTHESIA CONDUCTION FILTER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACUSNARE POLYPECTOMY SNARE SOFT

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC.·Product code KNS·May 23, 2014

    LOW PROFILE SELF TAPPING BONE SCREW 6.5MM X 25MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·November 22, 2010

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING·Product code FJI·January 4, 2013

    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