CORE

제조사

  • 제조사 모회사 (2017)
  • Source
    SATP

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 605 건

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  • 모델명 / 제조번호(시리얼번호)
    Recall includes only EX Catheter products (all Part/REF Numbers 2034-XXYY) with lot numbers less than (<) F09060003
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution.
  • 제품 설명
    AngioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, cutting/scoring, Easy Exchange (EX) delivery system, Manufactured by AngioScore, Fremont, CA. || Catheter is for use in the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for improving myocardial perfusion. The devices are available in balloon diameters of 2.0-3.5 mm in 0.5 mm increments, and in scoring balloon lengths of 10 to 15 nm. Catheter length is 139 cm and is compatible with 0.014 inch guide wires and 6F guide catheters. The EX catheter is supplied sterile and intended for single use.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    The recalling lot's for the product are as follows:  Model Number: 763114100X Lot #'s: 92661WY5, 93211XXV, 00141YVE, 00541ZKX, 010920HL, 01522192, 92791X5I, 93271Y1W, 00201YYE, 00621ZQ3, 011320LH, 015221BD, 92791X7X, 93411Y9O, 00211Z0C, 00671ZRN, 011720Q, 015521CL, 92861XCT, 93421YBJ, 00251Z1T, 00761ZZP, 012420U0, 016221H2, 93001XLG, 93431YBI, 00351Z86, 0081201Y, 0138211F, 016721KJ, 93081XPC, 93571YJO, 00461ZE2, 0088206B, 0141215R, 93141XST, 00061YOV, 00541ZK0, 009620BO, 0146219M.  Model Number: 763114160X Lot #'s 92661WY7, 00111YPZ, 00671ZRO, 013220Z7, 016221H7, 93131XLS, 00331Z61, 0110201Y, 014125Q, 00882065, 00391Z8Y, 013120YC, 015521CJ.  Model Number: 763114200X Lot #'s 92661WY0, 00751ZYJ, 012420U1  Model Number: 763116100X Lot #'s 92791X80, 93491YG9, 00331Z6M, 0083203O, 012420U3, 01672KL, 92791X81, 93501YGA, 00351Z8D, 009620BL, 013120Y9, 92931XDD, 00121YRT, 00431ZE1, 009920D3, 015221AX, 93001XLN, 00131YUG, 00541ZKV, 011020IU, 015221BE, 93081XPH, 00541ZJY, 00601ZOT, 011320LG, 015521CK, 93291Y43, 00251Z1R, 0081201W, 012020QC, 016221H3.  Model Number: 763116160X Lot #'s 92661WY3, 00882068, 00351Z8A, 00761ZZQ, 012020QB, 016721KK, 92791X89, 00912084, 00471ZG0, 010320FM, 012420TZ, 92861XD4, 01472193, 00541ZK1, 010920HK, 0141215U, 93001XLR, 00151YVC, 00601ZOR, 0110201V, 015521CM, 93291Y40, 00331Z6J, 00701ZUX, 011720OP, 016221HS  Model Number: 763116200X Lot #'s 121KN  Model Number: 763116200X Lot #'s 92671X09, 00471ZG1, 00882067, 010320FN, 00211Z09, 00601ZOP, 009920D0, 011020IT    Model Number: 763118100X Lot #'s 92661WY8, 93491YG7, 00331Z6L, 00621ZQ2, 009920D2, 0138213F, 92791X7Z, 93491YG8, 00351Z88, 00701ZUW, 010320FL, 01472194, 92861XDS, 00061YOT, 00471ZG2, 00761ZZO, 0110201W, 016221H4, 93091XPL, 00131YUF, 00541ZJZ, 0083203P, 012020QE, 93211XXW, 00251Z1S, 00541ZKU, 009620BM, 012420TX.    Model Number: 763118160X Lot #s 92661WY6, 93271Y1V, 00201YYD, 00471ZG3, 012420U2, 016221GZ, 92671WZJ, 93411Y9P, 00251Z1Q, 00671ZRK, 013120YB, 92671WZK, 93421YBK, 00331Z6N, 00701ZUY, 013220Z9, 92861XD0, 00061YOW, 00351Z8E, 00882069, 015221BB, 93001XLM, 00111YQO, 00431ZE3, 009920D4, 015521CO.   Model Number: 763118200X Lot #s 92861XCD, 93571YJN, 00331Z6K, 00671ZRM, 011320LF, 01382134, 93001XL6, 0061YOU, 00351Z89,00701ZUZ, 011720OO, 0141215S, 93001XLJ, 00912082, 00391Z8Z, 009620BQ, 012020QA, 01472195, 93081XPJ, 00111YQM, 00471ZG5, 009920D5, 013120Y8, 016221H1, 93211XXX, 00131YUD, 00481ZG4, 010320FJ, 013220Z6, 93400Y9K, 00201YYC, 00621ZQ1, 010920HJ, 0137211I.   Model Number: 763120100X Lot #s 93001XLV, 00351Z8B, 0088206A, 01472196, 00331Z60, 00601ZOS, 01202QF.   Model Number: 763120160X Lot #s 92661WY1, 00882066, 00111YQP, 00351Z8C, 013120YD, 01472197, 92861XDG, 00912083, 00211Z08, 00621ZQ5, 013220Z8.   Model Number: 763120200X Lot #s 00351Z85, 012020QG, 012420TW.  Model Number: 763418200X Lot #s 92671WZV, 93291Y41, 00351Z87, 00601ZNH, 010320FK, 0141215T, 92671WZW, 00061YOX, 00431ZE0, 0083203N, 0110201S, 015221BC, 92861XDH, 00131YUE, 00491ZIO, 009620BN, 0011720ON, 015521CN, 93081XPR, 00141YVB, 00541ZKT, 009920D1, 0138213E, 016221H6.  Model Number: 763418250X Lot #s 92751X60, 00671ZRL,   Model Number: 763418250X Lot #s 92661WY4, 93271Y1N, 00141YVD, 00601ZOQ, 0110201X, 013220ZA, 92751X6P, 93291Y42, 00211Z0B, 00761ZZR, 012020QD, 0137211G, 92781X5G, 93631YJP, 00221Z13, 0081201X, 012420TY, 01382133, 92861XDN, 00912085, 00431ZDZ, 009620BP, 013120YA, 016221H0.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA and countries including: Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Israel, Japan, New Zealand, Peru, South Africa, , Uruguay, and Venezuela.
  • 제품 설명
    Tru-Core II Disposable Automatic Biopsy Instrument and Tru-Core II URO Disposable Automatic Biopsy Instrument. The Tru-Core Disposable Automatic Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, prostate, breast, ect. The recalling lot's for the product are as follows: || Model Number: 763114100X || Lot #'s: || 92661WY5, 93211XXV, 00141YVE, 00541ZKX, 010920HL, 01522192, 92791X5I, 93271Y1W, 00201YYE, 00621ZQ3, 011320LH, 015221BD, 92791X7X, 93411Y9O, 00211Z0C, 00671ZRN, 011720Q, 015521CL, 92861XCT, 93421YBJ, 00251Z1T, 00761ZZP, 012420U0, 016221H2, 93001XLG, 93431YBI, 00351Z86, 0081201Y, 0138211F, 016721KJ, 93081XPC, 93571YJO, 00461ZE2, 0088206B, 0141215R, 93141XST, 00061YOV, 00541ZK0, 009620BO, 0146219M. || Model Number: 763114160X || Lot #'s || 92661WY7, 00111YPZ, 00671ZRO, 013220Z7, 016221H7, 93131XLS, 00331Z61, 0110201Y, 014125Q, 00882065, 00391Z8Y, 013120YC, 015521CJ. || Model Number: 763114200X || Lot #'s || 92661WY0, 00751ZYJ, 012420U1 || Model Number: 763116100X || Lot #'s || 92791X80, 93491YG9, 00331Z6M, 0083203O, 012420U3, 01672KL, 92791X81, 93501YGA, 00351Z8D, 009620BL, 013120Y9, 92931XDD, 00121YRT, 00431ZE1, 009920D3, 015221AX, 93001XLN, 00131YUG, 00541ZKV, 011020IU, 015221BE, 93081XPH, 00541ZJY, 00601ZOT, 011320LG, 015521CK, 93291Y43, 00251Z1R, 0081201W, 012020QC, 016221H3. || Model Number: 763116160X || Lot #'s || 92661WY3, 00882068, 00351Z8A, 00761ZZQ, 012020QB, 016721KK, 92791X89, 00912084, 00471ZG0, 010320FM, 012420TZ, 92861XD4, 01472193, 00541ZK1, 010920HK, 0141215U, 93001XLR, 00151YVC, 00601ZOR, 0110201V, 015521CM, 93291Y40, 00331Z6J, 00701ZUX, 011720OP, 016221HS || Model Number: 763116200X || Lot #'s || 121KN || Model Number: 763116200X || Lot #'s || 92671X09, 00471ZG1, 00882067, 010320FN, 00211Z09, 00601ZOP, 009920D0, 011020IT || Model Number: 763118100X || Lot #'s || 92661WY8, 93491YG7, 00331Z6L, 00621ZQ2, 009920D2, 0138213F, 92791X7Z, 93491YG8, 00351Z88, 00701ZUW, 010320FL, 01472194, 92861XDS, 00061YOT, 00471ZG2, 00761ZZO, 0110201W, 016221H4, 93091XPL, 00131YUF, 00541ZJZ, 0083203P, 012020QE, 93211XXW, 00251Z1S, 00541ZKU, 009620BM, 012420TX. || Model Number: 763118160X || Lot #s || 92661WY6, 93271Y1V, 00201YYD, 00471ZG3, 012420U2, 016221GZ, 92671WZJ, 93411Y9P, 00251Z1Q, 00671ZRK, 013120YB, 92671WZK, 93421YBK, 00331Z6N, 00701ZUY, 013220Z9, 92861XD0, 00061YOW, 00351Z8E, 00882069, 015221BB, 93001XLM, 00111YQO, 00431ZE3, 009920D4, 015521CO. || Model Number: 763118200X || Lot #s || 92861XCD, 93571YJN, 00331Z6K, 00671ZRM, 011320LF, 01382134, 93001XL6, 0061YOU, 00351Z89,00701ZUZ, 011720OO, 0141215S, 93001XLJ, 00912082, 00391Z8Z, 009620BQ, 012020QA, 01472195, 93081XPJ, 00111YQM, 00471ZG5, 009920D5, 013120Y8, 016221H1, 93211XXX, 00131YUD, 00481ZG4, 010320FJ, 013220Z6, 93400Y9K, 00201YYC, 00621ZQ1, 010920HJ, 0137211I. || Model Number: 763120100X || Lot #s || 93001XLV, 00351Z8B, 0088206A, 01472196, 00331Z60, 00601ZOS, 01202QF. || Model Number: 763120160X || Lot #s || 92661WY1, 00882066, 00111YQP, 00351Z8C, 013120YD, 01472197, 92861XDG, 00912083, 00211Z08, 00621ZQ5, 013220Z8. || Model Number: 763120200X || Lot #s || 00351Z85, 012020QG, 012420TW. || Model Number: 763418200X || Lot #s || 92671WZV, 93291Y41, 00351Z87, 00601ZNH, 010320FK, 0141215T, 92671WZW, 00061YOX, 00431ZE0, 0083203N, 0110201S, 015221BC, 92861XDH, 00131YUE, 00491ZIO, 009620BN, 0011720ON, 015521CN, 93081XPR, 00141YVB, 00541ZKT, 009920D1, 0138213E, 016221H6. || Model Number: 763418250X || Lot #s || 92751X60, 00671ZRL, || Model Number: 763418250X || Lot #s || 92661WY4, 93271Y1N, 00141YVD, 00601ZOQ, 0110201X, 013220ZA, 92751X6P, 93291Y42, 00211Z0B, 00761ZZR, 012020QD, 0137211G, 92781X5G, 93631YJP, 00221Z13, 0081201X, 012420TY, 01382133, 92861XDN, 00912085, 00431ZDZ, 009620BP, 013120YA, 016221H0.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Catalog number 000002N, Serial numbers: DYTA0001, DYTA0002, DYTA0003, DYTA0007, DYTA0008, DYTA0011, DYTA0012, DYTA0015, DYTA0016, DYTA0017, DYTA0018, DYTA0019, DYTA0020, DYTA0021, DYTA0022, DYTA0024, DYTA0025, DYTA0027, DYTA0028, DYTA0029, DYTA0030, DYTA0031, DYTA0032, DYTA0033, DYTA0034, DYTA0036, DYTA0037, DYTA0038, DYTA0039, DYTA0040, DYTA0041, DYTA0042, DYTA0043, DYTA0044, DYTA0045, DYTA0046, DYTA0047, DYTA0049, DYTA0050, DYTA0051, DYTA0052, DYTA0053, DYTA0054, DYTA0056, DYTA0057, DYTA0058, DYTA0059, DYTA0060, DYTB0001, DYTB0003, DYTB0004, DYTB0005, DYTB0009, DYTB0010, DYTB0011, DYTB0012, DYTB0013, DYTB0015, DYTB0016, DYTB0020, DYTB0021, DYTB0022, DYTB0023, DYTB0024, DYTB0025, DYTB0026, DYTB0027, DYTB0029, DYTB0030, DYTB0031, DYTB0033, DYTB0038, DYTC0001, DYTC0004, DYTC0010, DYTC0011, DYTC0016, DYTC0017, DYTC0018, DYTC0019, DYTC0020, DYTC0021, DYTC0022, DYTC0024, DYTC0025, DYTC0026, DYTC0027, DYTC0029, DYTC0030, DYTC0031, DYTC0032, DYTC0033, DYTC0034, DYTC0035, DYTC0036, DYTC0037, DYTC0038, DYTC0039, DYTC0040, DYUC0001, DYUC0002, DYUC0004, DYUC0005, DYUC0009, DYUC0012, DYUC0014, DYUC0015, DYUC0016, DYUC0017, DYUC0018, DYUC0019, DYUC0020, DYUD0001, DYUD0002, DYUD0003, DYUD0004, DYUD0005, DYUD0006, DYUD0007, DYUD0008, DYUD0009, DYUD0011, DYUD0012, DYUD0013, DYUD0014, DYUD0015, DYUD0016, DYUD0017, DYUD0019, DYUD0020, DYUD0021, DYUD0022, DYUD0023, DYUD0026, DYUD0027, DYUD0028, DYUD0029, DYUD0030, DYUD0031, DYUD0033, DYUD0034, DYUD0035, DYUD0036, DYUD0037, DYUD0038, DYUD0039, DYUD0042, DYUD0043, DYUD0045, DYUD0046, DYUD0047, DYUD0048, DYUD0049, DYUD0050, DYUD0052, DYUD0053, DYUD0055, DYUD0057, DYUD0058, DYUD0059, DYUE0002, DYUE0007, DYUE0008, DYUE0011, and DYUE0014.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- U.S., Netherlands, and Japan.
  • 제품 설명
    Bard¿ CritiCore¿ Monitor, Software Version 2.1, Catalog number 000002N, C.R. Bard, Inc., Covington, GA 30014. || Intended for multiple uses as it is an electronic battery-operated monitor used in conjunction with a single-use disposable urine collection container and/or a temperature sensing Foley catheter
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Catalog # TSCFB-/-BH Affected lots range from: F3734676 - F4911986 NS4938980 - NS6144078
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationally
  • 제품 설명
    Fixed Core Bentson
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Catalog numbers: CSG/WORLEY/BCor-1-09; CSG/WORLEY/BCor-2-09; CSG/WROLEY/L/BCor-1-09; CSG/Worley/R-1-09; CSGWORBC10M; CSGWORBC29M; CSGWORLBC19M; LVI/66-5.5-CR; LVI/66-5.5-RE; LVI/75-5-62-07-HO; LVI/75-5-62-07-HS; LVI/75-5-62-07-MP; LVI/75-5-62-07-RE; LVI/75-5-66-5.5-RE; LVI/Tele/B-60-07-HO; LVI/Tele/B-60-07-HS; LVI/Tele/B-60-07-MP; LVI/Tele/B-60-07-RE; RL065; RL066; RL067; and RL068.  Lot Numbers: S24064, S24120; S24129; S24359; S24618; S24683; S24838; S24932; S25222; S25489; S25540; S25544; S25772; S25937; S25945; S26333; S26420; S26460; S36539; S36540; S26560; S36759; S36861; S26881; S26987; S27221; S27222; S27275; S27288; S27370; S27477; S27478; S27947; S27971; S27985; S28023; S28172; S28306; S28339; S28401; S28632X1; S28791; S29083; S29878; S30060X1; S30262X1; S30332X1; S30333X1; S30622X1; S30630; S30739; S30852X1; S30889X1; S30901X1; S30913; S30919X1; S30956X1; S30970; S30986X1; S30997X1; S31005X1; S31045; S31076; S31080X1; S31081; S31097; S31098; S31142X1; S31212X1; S31215X1; S31245; S31306; S31316; S31327X1; S31331X1; S31334; S31340; S31341; S31439; S31507; S31533X1; S31534X1; S31535X1; S31563; S31650; S31674; S31709; S31771X1; S31779X1; S31917X1; S31962;S32102; S32139; S32156; S32167; S32178X1; S32219; S32222; S32238; S32263; S32282; S32308; S32327; S32506X1; S32543X1; S32565X1; S32566X1; S32568X1; S32602; S32605X1; S32610; S32675; S32684; S32699X1; S32714; S32715; S32716; S32717; S32737; S32765; S32796; S32831; S32882; S32957; S32994; S33026; S33065; S33067; S33076; S33084; S33129; S33149X1; S33161X1; S33236; S33238; S33301; S33322; S33324; S33398; S33399; S33403; S33412; S33478; S33543; S33544; S33614; S33649; S33687; S33758; S33889; S33921; S33939; S34026; S34082; S34096; S34342; S34375; S34485; S34689; S34690; S36110X1; and S36118X1.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: CA only.
  • 제품 설명
    SafeSheath(R) CSG(R) Coronary Sinus guide Braided Core Hemostatic Introducer, SafeSheath(R) Worley Telescopic Braided Series, and Situs LDS2 Lead Delivery System - Catalog numbers: CSG/WORLEY/BCor-1-09; CSG/WORLEY/BCor-2-09; CSG/WROLEY/L/BCor-1-09; CSG/Worley/R-1-09; CSGWORBC10M; CSGWORBC29M; CSGWORLBC19M; LVI/66-5.5-CR; LVI/66-5.5-RE; LVI/75-5-62-07-HO; LVI/75-5-62-07-HS; LVI/75-5-62-07-MP; LVI/75-5-62-07-RE; LVI/75-5-66-5.5-RE; LVI/Tele/B-60-07-HO; LVI/Tele/B-60-07-HS; LVI/Tele/B-60-07-MP; LVI/Tele/B-60-07-RE; RL065; RL066; RL067; and RL068 || This device is intended to be used for the introduction of various types of pacing or defibrillator leads and catheters.
  • Manufacturer
하나 더 600 건 더