Device Recall Boston Scientific

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 7889257, 7892749, 7924670, 7924672, 7944542, 7948443, 7948444, 7959299, 7959300, 7975078, 7975079, 7979468, 7979469, 7991051, 7991054, 7998758, 7998759, 7998760, 8002684, 8002685, 8014025, 8041040, 8041041, 8041222, 8052772, 8052774, 8060259, 8071855, 8071856, 8075138, 8080170, 8093632, 8109650, 8109651, 8114689, 8117678, 8131078, 8151476, 8155398, 8166781, 8170747, 8174687, 8174689, 8187008, 8191493, 8206779, 8206780, 8211778, 8211779, 8214766, 8226828, 8230827, 8230830, 8231159, 8268293, 8272150, 8272151, 8284684, 8284685, 8290955, 8306944, 8319230, 8319231, 8339003, 8339005, 8343275, 8343279, 8347008, 8367859, 8367860, 8367861, 8385775, 8385776, 8385777, 8389894, 8389895, 8401051, 8406650, 8406651, 8406652, 8427648, 8427649, 8431394, 8449739, 84623248, 8466568, 8466569, 8466570, 8474529, 8474530, 8474531, 8482833, 8486629, 8486630, 8486631, 8503298, 8503299, 8503300, 8505352, 8505353, 8505354, 8505355, 8505356, 8505357, 8505358, 8505359, 8505360, 8505361, 8505362, 8505363, 8505364, 8507020, 8511088, 8526132, 8526135, 8547345, 8547346, 8551223, 8551224, 8567704, 8571917, 8571918, 8571919, 8583897, 8583898, 8583899, 8591867, 8611580, 8611581, 8614222, 8648847, 8648849, 8648850, 8655868, 8655869, 8683744, 8688103, 8692109, 8706158, 8709576, 8709923, 8709975, 8724559, 8724560, 8727932, 8727933, 8752575, 8766341, 8766342, 8775286, 8775287, 8810553, 8810554, 8810570, 8814730, 8815105, 8844670, 8844671, 8844872, 8849235, 8849236, 8849237, 8853318, 8853319, 8867181, 8893397, 8898058, 8902082, 8902083, 8913833, 8935976, 8935977, 8935978, 8948215, 8976949, 9132297, 9132373, 9132374, 9132375, 9132376, 9132377, 9132378, 9132379, 9132380, 9132381, 9132382, 9132383, 9132384, 9132385, 9132386, 9132387, 9132388, 9132389
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution --- USA and countries of Austria, Belgium, France, Czech Republic, Germany, great Britain, Greece,Ireland, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Spain, Switzerland, and Sweden.
  • 제품 설명
    Wallstent Endoscopic Biliary Endoprosthesis 10mm x 80mm, UPN H965430600
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Boston Scientific Corporation, One Boston Scientific Place, Natick MA 01760
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 174 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 11712923
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    NJ, SC, TN, VA, and WI
  • 제품 설명
    EndoVive Safety PEG Kits 20 F || Universal Product Number (UPN): MOO566460 || The product provides nutrition directly into the stomach of adult and pediatric patients who are unable to consume by conventional methods.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    US Lot/Batch #: C71403, C71404, C71405, C71406, C71501, C71502, C71601, C71602, C72302, C72303, C72401, C72402, C72403, C72404, C72701, C72801, C72802, C72803, C72901, C72902, C72903, C72904, C73002, C73003, C73103, C73104, C73105, C73201, C73202, C73203, C73204, C73205, C73301, C73302, C73401, C73402, C73601, C73602, C73801, C74301, C74302, C74401, C74502, C74601, C74701, C80201, C80202, C80203, C80301, C80401, C80402, C80403, C80501, C80801, C80802, C81001, C81002, C81102, C81201, C81202, and C81203.   OUS Lot/Batch #: C72501, C72502, C72601, C72602, C72905, C73001, C73004, C73101, C73102, C73901, C73902, C73903, C74001, C74002, C74003, and C74101
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution: USA, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Italy, Kuwait, Luxembourg, Netherlands, Norway, Panama, Poland, Portugal, Romania, Spain, Switzerland, and Ukraine.
  • 제품 설명
    Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System. Material Number (UPN) M001553030, Catalog Number 55-303. [OUS Material Number (UPN) M001553000, Catalog Number 55-300]
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot / Batch #: 7908999, 7945613, 7968042, 8002696, 8049604, 8152432, 8181321, 8188798, 8189027, 8260367, 8289723, 8343908, 8350907, 8418323, 8435607, 8506420, 8529856, 8550971, 8584215, 8620500, 8632756, 8632757, 8636509, 8644935, 8656636, 9175918, 9183100, 9200564, 9455621, 9512879, 9521733, 9535932, 9656252, 9747125, 9813152, 11043633, 11122070, 11181968, 11182772, 11194875, 11259816, 11276388, 11328172, 11342423, 11363879, 11518115, 11604154, and 11665770
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN,MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, SI, WV, and WY. OUS locations to include: Balkans, Finland, Germany, Great Britain, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Romania, Saudia Arabia, Spain, Sweden, Switzerland, and United Arab Emirates
  • 제품 설명
    Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917511, Catalog # 1751, Material No. [Inner Pouch Label] H74917510. Sterilized with ethylene oxide gas. The Platinum Plus Guidewire has been designed to provide torsional control. The guidewire has a shapeable and highly radiopaque distal platinum tip. Legal Manufacturer: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot / Batch #: 7871050, 7874112, 7901492, 7908998, 7935372, 7942404, 7946750, 7951989, 7979004, 7987978, 8002687, 8002688, 8025772, 8049137, 8056451, 8076852, 8098810, 8100687, 8115174, 8152431, 8181521, 8181914, 8182172, 8188799, 8193187, 8196976, 8199191, 8200479, 8200913, 8250949, 8252697, 8254876, 8260512, 8267344, 8268818, 8276225, 8281144, 8290915, 8334503, 8344727, 8352846, 8355028, 8356527, 8364588, 8410167, 8410168, 8418161, 8436013, 8439527, 8487277, 8494510, 8494814, 8506052, 8517771, 8529765, 8533184, 8547526, 8547528, 8548109, 8563958, 8584214, 8599724, 8620506, 8621310, 8623982, 8624400, 8624593, 8636348, 8636397, 8636409, 8636503, 8641950, 8833124, 8844258, 8856203, 9095461, 9111353, 9115679, 9115681, 9127229, 9157914, 9161086, 9183101, 9183105, 9185694, 9185695, 9188841, 9200553, 9222896, 9255968, 9261438, 9296807, 9297103, 9320040, 9339417, 9339418, 9346642, 9346643, 9368448, 9431674, 9431675, 9431676, 9435282, 9477092, 9478619, 9506755, 9506757, 9506865, 9521490, 9521491, 9521492, 9569394, 9581945, 9581946, 9583721, 9598709, 9603497, 9605899, 9637090, 9640999, 9644150, 9656493, 9656494, 9687546, 9784975, 9804363, 9822697, 11070550, 11099161, 11129198, 11132701, 11181779, 11181961, 11194872, 11204324, 11205127, 11208660, 11210322, 11243379, 11257970, 11258088, 11279186, 11279187, 11304665, 11304666, 11314418, 11314419, 11331413, 11342422, 11364163, 11364164, 11364441, 11364625, 11367614, 11368112, 11381445, 11381446, 11381713, 11400941, 11400942, 11413485, 11416911, 11416912, 11419631, 11421390, 11441801, 11455976, 11466878, 11482433, 11485605, 11491642, 11566831, 11576501, 11576502, 11604153, 11610376, 11610377, 11631997, and 11632322.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN,MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, SI, WV, and WY. OUS locations to include: Balkans, Finland, Germany, Great Britain, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Romania, Saudia Arabia, Spain, Sweden, Switzerland, and United Arab Emirates
  • 제품 설명
    Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917521, Catalog # 1752, Material No. [Inner Pouch Label] H74917520. Sterilized with ethylene oxide gas. The Platinum Plus Guidewire has been designed to provide torsional control. The guidewire has a shapeable and highly radiopaque distal platinum tip. Legal Manufacturer: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot / Batch #: 8507682, 8529860, 9012874, 9249774, 9249775, and 9830636.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN,MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, SI, WV, and WY. OUS locations to include: Balkans, Finland, Germany, Great Britain, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Romania, Saudia Arabia, Spain, Sweden, Switzerland, and United Arab Emirates
  • 제품 설명
    Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917531, Catalog # 1753, Material No. [Inner Pouch Label] H74917530. Sterilized with ethylene oxide gas. The Platinum Plus Guidewire has been designed to provide torsional control. The guidewire has a shapeable and highly radiopaque distal platinum tip. Legal Manufacturer: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA.
  • Manufacturer
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