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    AUTOCLIX

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

    InCompass®

    FDA UDI
    ZIMMER SPINE, INC.·00889024401563·

    Momentum

    FDA UDI
    Ulrich Medical Usa, Inc.·00814386025867·Navigated tap, Ø 7.5mm, non-cannulated, 1/4"-sq...

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517077001·

    MINUET LCD, MINUET LCD eco

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    TEKNIQUE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PORTEX

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code JOH·December 17, 2020

    NC QUANTUM APEX?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·May 14, 2014

    2531779-2012-12947

    FDA Adverse Event
    Injury ·ANIMAS CORP.·October 31, 2012

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·August 13, 2010

    3.0MM TI HEADLESS COMPRESSION SCREW-SHORT THREAD 20MM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·January 11, 2021

    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 Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code BTO·June 7, 2024

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·May 20, 2015

    Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143. Used to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·May 7, 2014

    Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·May 20, 2015

    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