Boston Scientific Corporation

6 devices in the database

  • Model / Serial
    Lot Number: 7552069
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    TX, KY
  • Product Description
    Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-299, UPN M001182990
  • Model / Serial
    Unit Numbers: IN0339JC, IN0340JC,
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide-USA, UK, Denmark, Italy, and France
  • Product Description
    HTA Console System, 230 Volt , Italian, || Product Number: 56001 IO (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)
  • Model / Serial
    Unit Numbers: IN0350JG, IN0351JG,
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide-USA, UK, Denmark, Italy, and France
  • Product Description
    HTA Console System, 230 Volt , French, Product Number: 56001FO (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)
  • Model / Serial
    Unit Numbers: IN0335JC, IN0344JE, IN0345JE, IN0349JE, IN0352JG, IN0353JG, IN0355JG, IN0356JG
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide-USA, UK, Denmark, Italy, and France
  • Product Description
    HTA Console System, 230 Volt, Product Number: 56001 DO- English Demonstration Evaluation Unit (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)
  • Model / Serial
    Unit Numbers: IN0335JC, IN0337JC, IN0341JD, IN0342JD, IN0343JD, IN0344JE, IN0345JE, IN0347JE, IN0348JE, IN0349JE, IN0352JG, IN0353JG, IN0355JG, IN0356JG
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide-USA, UK, Denmark, Italy, and France
  • Product Description
    HTA Console System, 230 Volt, English, Product Number: 560010 (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)
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63 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    TDMDAT
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    NIDFSINVIMA
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    NIDFSINVIMA
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    NIDFSINVIMA
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    AMPMDC
58 more