Boston Scientific Pty Ltd

34 dispositifs dans la base de données

  • Modèle / numéro de série
    Capio Suture Capturing Devices (SLIM, Standard, Open Access, RP) For use with:- Uphold Vaginal Support System (ARTG:150342) - Discontinued - Uphold LITE with Capi SLIM Vaginal Support System (ARTG:150342) - Discontinued - Pinnacle Anterior Pelvic Floor Repair Kit (ARTG:150342) - Discontinued- Pinnacle Posterior Pelvic Floor Repair Kit (ARTG:150342) - Discontinued - Pinnacle LITE Posterior with Capio SLIM Pelvic Floor Repair Kit (ARTG: 246992) - DiscontinuedARTG Number: 137473
  • Modèle / numéro de série
    VALITUDE CRT-PModel U128ARTG 279333RESONATE CRT-DModel G447ARTG 296562MOMENTUM CRT-DModel G124, G125, G126, G128ARTG 296563, 296564, 296565, 296566AUTOGEN CRT-DModels G172, G173, G175, G177, G179ARTG 221615, 221616, 221617, 221618, 221633VISIONIST CRT-PModels U225, U226, U228ARTG 279330, 279331, 279332DYNAGEN CRT-DModels G151, G156, G158ARTG 221620, 221621, 221622
  • Classification du dispositif
  • Modèle / numéro de série
    VALITUDE CRT-P Model U128ARTG 279333VISIONIST CRT-P Models U225, U226, U228ARTG 279330, 279331, 279332ACCOLADE PacemakersModels L310, L311, L331ARTG 280319, 280315, 280316PROPONENTpacemakers Models L210, L211, L231ARTG 280320, 280317, 280318
  • Classification du dispositif
  • Modèle / numéro de série
    Uphold LITE with Capio SLIM and Solyx Single Incision Sling System Catalogue Numbers: M0068318170 and M0068507000ARTG Numbers: 150342 and 104326
  • Classification du dispositif
  • Modèle / numéro de série
    Malecot Nephrostomy Catheter SetMaterial Numbers: M0064101000, M0064101010All batch number are affectedARTG Number: 125167
  • Classification du dispositif
29 en plus

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  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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.”
  • Représentant du fabricant
    Medilife
  • Source
    RLMPH