Medtronic Australasia Pty Ltd

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Description

110 devices in the database

  • Model / Serial
    Guardian Connect Mobile AppPart number: CSS7200 ARTG Number : 276924(Medtronic Australasia Pty Ltd - Information system software, application program, patient record)
  • Model / Serial
    EnTrust VR/DR/AT ICDsModels: D154ATG and D154VRCARTG Numbers: 119254; 119256 (both cancelled)
  • Product Classification
  • Model / Serial
    Percepta CRT-P MRI SureScan (W1TR04) and Percepta Quad CRT-P MRI SureScan (W4TR04)ARTG Numbers: 291818 (Medtronic Australasia Pty Ltd - Percepta CRT-P MRI SureScan W1TR04 - Biventricular pacemaker)291819 (Medtronic Australasia Pty Ltd - Percepta Quad CRT-P MRI SureScan W4TR04 - Biventricular pacemaker)
  • Product Classification
  • Model / Serial
    StraightShot Microdebrider BladesBlade Skimmer 3pk 3.5mm 22.5cmModel Number: 1883523Lot Numbers: 214388556, 214861292, HG20DTQ and HG21X3JBlade Tricut 5pk 3.5mmModel Number: 1883504Lot Numbers: 0214435413, 0214630819, 0214631786, HG1YVYF, HG1Y58E, HG21X15, HG21CX2 and HG1ZTFTBlade 3pk Skimmer Ang 18cmModel Number: 1883525Lot Numbers: HG20VDV and HG1YSR6ARTG Number: 117118
  • Model / Serial
    Covidien Endo GIA Articulating Reloads with Tri-Staple TechnologyEndo GIA 45mm Articulating Medium/Thick Reload with Tri-Staple Technology Item Code: EGIA45AMT Lot: N7L0521KXARTG:181429 Endo GIA 45mm Extra Thick Black Articulating Reload with Tri-Staple TechnologyItem Code: EGIA45AXT Lots: N8A0907KX and N8A0146KX ARTG:181429Endo GIA 60mm Articulating Vascular/Medium Loading Unit with Tri-Staple TechnologyItem Code: EGIA60AVM Lot: N8B0088KX ARTG:186247
  • Product Classification
105 more

2 manufacturers with a similar name

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  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    NZMMDSA
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    RLMPH