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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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FLAIR® Endovascular Stent Graft 7 mm x 30 mm (80 cm delivery catheter)(flared)
Bard Peripheral Vascular, Inc.
FAF07030
Not in Commercial Distribution

  • 04049519008776 ()
  • 14049519008773 ()

  • Implant Diameter,7 Millimeter
  • Catheter Length,80 Centimeter
  • Implant Length,30 Millimeter
FAF07030

  • Peripheral artery endovascular stent-graft, non-medicated
FLAIR® Endovascular Stent Graft 6 mm x 70 mm (80 cm delivery catheter)(flared)
Bard Peripheral Vascular, Inc.
FAF06070
Not in Commercial Distribution

  • 04049519008769 ()
  • 14049519008766 ()

  • Catheter Length,80 Centimeter
  • Implant Length,70 Millimeter
  • Implant Diameter,6 Millimeter
FAF06070

  • Peripheral artery endovascular stent-graft, non-medicated
FLAIR® Endovascular Stent Graft 6 mm x 50 mm (80 cm delivery catheter)(flared)
Bard Peripheral Vascular, Inc.
FAF06050
Not in Commercial Distribution

  • 04049519008752 ()
  • 14049519008759 ()

  • Implant Length,50 Millimeter
  • Catheter Length,80 Centimeter
  • Implant Diameter,6 Millimeter
FAF06050

  • Peripheral artery endovascular stent-graft, non-medicated
FLAIR® Endovascular Stent Graft 6 mm x 40 mm (80 cm delivery catheter)(flared)
Bard Peripheral Vascular, Inc.
FAF06040
Not in Commercial Distribution

  • 04049519008745 ()
  • 14049519008742 ()

  • Catheter Length,80 Centimeter
  • Implant Diameter,6 Millimeter
  • Implant Length,40 Millimeter
FAF06040

  • Peripheral artery endovascular stent-graft, non-medicated
FLAIR® Endovascular Stent Graft 6 mm x 30 mm (80 cm delivery catheter)(flared)
Bard Peripheral Vascular, Inc.
FAF06030
Not in Commercial Distribution

  • 04049519008738 ()
  • 14049519008735 ()

  • Catheter Length,80 Centimeter
  • Implant Diameter,6 Millimeter
  • Implant Length,30 Millimeter
FAF06030

  • Peripheral artery endovascular stent-graft, non-medicated
The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.
THEROX, INC.
SSO2 - 5.0
In Commercial Distribution

  • 20862478000463 ()
  • 00862478000469 ()
  • 10862478000466 ()

  • 5F


  • Supersaturated oxygen therapy system catheter
The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.
THEROX, INC.
SSO2 - 4.5
In Commercial Distribution

  • 20862478000456 ()
  • 00862478000452 ()
  • 10862478000459 ()

  • 5F


  • Supersaturated oxygen therapy system catheter
The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.
THEROX, INC.
SSO2 - 3.5
In Commercial Distribution

  • 20862478000449 ()
  • 00862478000445 ()
  • 10862478000442 ()

  • 5F


  • Supersaturated oxygen therapy system catheter
The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.
THEROX, INC.
SSO2 - 4.0
In Commercial Distribution

  • 20862478000432 ()
  • 00862478000438 ()
  • 10862478000435 ()

  • 5F


  • Supersaturated oxygen therapy system catheter
The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.
THEROX, INC.
DSC-2
In Commercial Distribution

  • 10862478000428 ()
  • 00862478000421 ()


  • Supersaturated oxygen therapy system cartridge
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