BEUDAMED
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    BRANEMARK SYSTEM TITANIUM COVER SCREWS

    FDA 510(k)
    FDA Class 2 ·Dental

    COULTER DART AST (GOT) REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MINIDAM II

    FDA 510(k)
    FDA Class 1 ·Dental

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 17, 2014

    ASKU

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code LWP·December 14, 2010

    CURRENT PLUS DR

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·January 22, 2013

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

    smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/060CZ; 2) BLUSELECT 7.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/070CZ; 3) BLUSELECT 7.5, CUFFED, NON-FEN, 10/BX, Item Number 101/800/075CZ; 4) BLUSELECT 8.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/080CZ; 5) BLUSELECT 8.5, CUFFED, NON-FEN, 10/BX, Item Number 101/800/085CZ; 6) BLUSELECT 9.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/090CZ; 7) BLUSELECT 10.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/100CZ; 8) BLUSELECT 6.0, CUFFED, FEN, 10/BX, Item Number 101/802/060CZ; 9) BLUSELECT 7.0, CUFFED, FEN, 10/BX, Item Number 101/802/070CZ; 10) BLUSELECT 7.5, CUFFED, FEN, 10/BX, Item Number 101/802/075CZ; 11) BLUSELECT 8.0, CUFFED, FEN, 10/BX, Item Number 101/802/080CZ; 12) BLUSELECT 8.5, CUFFED, FEN, 10/BX, Item Number 101/802/085CZ; 13) BLUSELECT 9.0, CUFFED, FEN, 10/BX, Item Number 101/802/090CZ; 14) BLUSELECT 10.0, CUFFED, FEN, 10/BX, Item Number 101/802/100CZ; 15) BLUSELECT 6.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/060CZ; 16) BLUSELECT 7.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/070CZ; 17) BLUSELECT 7.5, CUFFED, NON-FEN, 1/EA, Item Number 101/810/075; 18) BLUSELECT 7.5, CUFFED, NON-FEN, 1/EA, Item Number 101/810/075CZ; 19) BLUSELECT 8.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/080; 20) BLUSELECT 8.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/080CZ; 21) BLUSELECT 8.5, CUFFED, NON-FEN, 1/EA, Item Number 101/810/085CZ; 22) BLUSELECT 9.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/090CZ; 23) BLUSELECT 10.0, CUFFED, NON-FEN, 1/EA, Item Number 101/810/100CZ; 24) BLUSELECT 6.0, CUFFED, FEN, 1/EA, Item Number 101/812/060CZ; 25) BLUSELECT 7.0, CUFFED, FEN, 1/EA, Item Number 101/812/070CZ; 26) BLUSELECT 7.5, CUFFED, FEN, 1/EA, Item Number 101/812/075CZ; 27) BLUSELECT 8.0, CUFFED, FEN, 1/EA, Item Number 101/812/080CZ; 28) BLUSELECT 8.5, CUFFED, FEN, 1/EA, Item Number 101/812/085CZ; 29) BLUSELECT 9.0, CUFFED, FEN, 1/EA, Item Number 101/812/090CZ; 30) BLUSELECT 10.0, CUFFED, FEN, 1/EA, Item Number 101/812/100CZ; 31) BLUSELECT 6.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/060; 32) BLUSELECT 7.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/070; 33) BLUSELECT 7.5, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/075; 34) BLUSELECT 8.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/080; 35) BLUSELECT 8.5, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/085; 36) BLUSELECT 9.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/090; 37) BLUSELECT 10.0, CUFFED, NON-FEN, W/WEDGE, 1/EA, Item Number 101/815/100; 38) BLUSELECT 6.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/060; 39) BLUSELECT 7.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/070; 40) BLUSELECT 8.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/080; 41) BLUSELECT 9.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/090; 42) BLUSELECT 10.0, CUFFED, FEN, W/WEDGE AND DECAN CAP, 1/EA, Item Number 101/817/100; 43) BLUSELECT 6.0, SUCTIONAID, CUFFED, NON-FEN,10/BX, Item Number 101/860/060CZ; 44) BLUSELECT 7.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/070CZ; 45) BLUSELECT 7.5, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/075CZ; 46) BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/080CZ; 47) BLUSELECT 8.5, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/085CZ; 48) BLUSELECT 9.0, SUCTIONAID, CUFFED, NON-FEN, 10/BX, Item Number 101/860/090CZ; 49) BLUSELECT 10.0, SUCTIONAID, CUFFED, NON-FEN,10/BX, Item Number 101/860/100CZ; 50) BLUSELECT 6.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/060CZ; 51) BLUSELECT 7.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/070CZ; 52) BLUSELECT 7.5, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/075CZ; 53) BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA, Item Number 101/870/0

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 18, 2024