Edwards Lifesciences, LLC

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 23 건

  • 모델명 / 제조번호(시리얼번호)
    Lots: 59134589;59346136;59499481;59609044;59717943;59138591;59192007;59149674;59350916;59514123;59620244;59723313;59138592;59199148;59202405;59370449;59528372;59625386;59723318;59148881;59207364;59222648;59409903;59528392;59634884;59735991;59149673;59211452;59245610;59414824;59541717;59651860;59747795;59149675;59211456;59245648;59453572;59555076;59662625;59758989;59151406;59216325;59266772;59456447;59563964;59680248;59769429;59161706;59218844;59283731;59458072;59568501;59691477;59774986;59163769;59229509;59309184;59463365;59577224;59695811;59791798;59179981;59229512;59319451;59490087;59604744;59706987;59813426;59182987;59232182;59342295;59491855;59604746;59717942;59839270;59192002;59235535;59245625;59328438;59409901;59509316;59615872;59680180;59758991;59245650;59328440;59413359;59518784;59615876;59680270;59759002;59245652;59329235;59414819;59523751;59620242;59684868;59763554;59258285;59346138;59431972;59531242;59620243;59702379;59774995;59271794;59346146;59453598;59536690;59620327;59706982;59780342;59271795;59350911;59456450;59541842;59630423;59706985;59786179;59283729;59350921;59458056;59555081;59634892;59712080;59796688;59287254;59354987;59458061;59563850;59634893;59712081;59796692;59290438;59354988;59463367;59568469;59640081;59723317;59801791;59295439;59365157;59473421;59572996;59640085;59723320;59813418;59295506;59365159;59473422;59577180;59640108;59729757;59824882;59299876;59378069;59484139;59581494;59651780;59729759;59824891;59304307;59383861;59490088;59581564;59651850;59729761;59836965;59304308;59390115;59490089;59583327;59662626;59735981;59839272;59304310;59390121;59491856;59589933;59662638;59735983;59844549;59312984;59391051;59491858;59589951;59675187;59735987;59319447;59404539;59499480;59604747;59680142;59747805;59321329;59409878;59504238;59609041;59680148;59751061;
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia. US Territory: Puerto Rico and Internationally to Australia, Bangladesh, Brazil, Canada, Chile, China, Colombia, Hong Kong, India, Japan, Malaysia, Mexico, Netherlands, Singapore, South Korea, Sri Lanka, Taiwan, and Venezuela.
  • 제품 설명
    Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Model Numbers: E061, E060, PE062, EM012 || Atrial Vent Catheters are intended for venting the left heart during short-term ( d 6 hrs) cardiopulmonary bypass. Avoid direct ventriculotomy with entry into the left atrium across the mitral valve and into the left ventricle. Left Ventricular Vent Catheters are intended for venting the left ventricle during short-term ( 6 hrs) cardiopulmonary bypass. Entrance is made into the left ventricle. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired. Vent Catheters may be used in pediatric or adult populations based on individual patient anatomy.
  • 모델명 / 제조번호(시리얼번호)
    Model No: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: US (nationwide) and country of: Canada.
  • 제품 설명
    Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D. || The EMBOL-X access device is indicated for the perfusion of the ascending aorta during short-term (less than or equal to0¿ 6 hours) cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 58749813, 58802303, 58836847, 58877405, 58909346, 59011910, 59035360, 59085935, 59118391, 59241531, 58705682, 58711964, 58722234, 58771175, 58837337, 58855247, 58904182, 58927518, 58936037, 58936014, 58936027, 59009635, 59030253, 59056470, 59103213, 59124020, 59199172, 59218725, 59235997.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) including the states of CT, TX, CA, AZ, MO, and MD and the countries of Europe and Japan.
  • 제품 설명
    Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. || Product Usage: These suction catheters are typically used to remove fluid on the external surface of the heart during cardiac surgery and therefore there is little risk of intravascular involvement.
  • 모델명 / 제조번호(시리얼번호)
    lot 59617777 and 59658495.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution
  • 제품 설명
    Crimper Model 9100CR26 || The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 11211566.1, Exp. Date: 09/01/2017.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributed to 3 customers in FL only.
  • 제품 설명
    Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330. || The Edwards Surgical Instruments are designed to perform specialized functions in specific cardiac surgical or endoscopic procedures.
하나 더 18 건 더

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 4 건

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 주소
    Edwards Lifesciences, Llc, 1 Edwards Way, Irvine CA 92614-5688
  • Source
    USFDA