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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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The Catheter Access Kit is sterile and provides the components and instructions necessary to access the catheter access port of the Prometra Programmable Pump. The catheter access port is located on the periphery of the pump to allow for direct access to the catheter without interfering with the drug reservoir.
Flowonix Medical, Inc.
11824
In Commercial Distribution

  • 00810335020136 ()


  • General surgical procedure kit, non-medicated, single-use
The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Calibration Equipment is a component of the Cordella Pulmonary Artery Sensor System. The Calibration Equipment (CalEQ) is hospital equipment that supports the implantation procedure. The main functions of Calibration Equipment include: • Interrogates the Cordella Sensor to verify proper working condition. • Facilitates linking of component serial numbers to patient IDs. • Calibrates the Cordella Sensor to a reference pressure at the time of implantation. • Trains patient on optimal Reader placement post-procedure. • Recalibrates the Cordella Sensor to a reference pressure post-implant. • CalEQ is operated by Endotronix personnel only.
Endotronix, Inc.
100622-00
In Commercial Distribution

  • 00850008997020 ()


  • Implantable pulmonary artery pressure monitoring system
The EndoForce™ Connector for Endovascular Venous Anastomosis (herein referred to as the EndoForce™ System) includes an implantable component, the EndoForce™ Connector and a delivery system, EndoForce™ Connector Delivery System. The EndoForce Connector™ is a venous anastomosis implant used in conjunction with a 6 mm inner diameter expanded polytetrafluoroethylene (ePTFE) arteriovenous graft (not provided). The graft is sutured to the artery using a conventional anastomosis. The graft, and not the EndoForce™ Connector, is to be used for vascular access during hemodialysis in patients with end stage renal disease. The EndoForce™ Connector is provided pre-loaded within the EndoForce™ Connector Delivery System.
Phraxis Inc.
EFORCE-100
In Commercial Distribution

  • 00860014060601 ()

  • Stent Length: 66 Millimeter


  • Synthetic vascular graft
TriVisc™ 850 sodium hyaluronate (P160057) is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. TriVisc is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) with an average molecular weight of 850,000 daltons and a range of 620,000 – 1,170,000 daltons). The HA is a polymer of repeating disaccharide units of glucuronic acid and N-acetyl-glucosamine derived from a bacterial fermentation process. TriVisc is supplied in a prefilled syringe containing 25 mg of HA in 2.5 mL of physiological saline solution (1% solution).
Avanos Medical, Inc.
50653-0006-04
In Commercial Distribution

  • 10850653006044 ()
  • 00850653006047 ()
  • 20850653006041 ()


  • Synovial fluid supplementation medium
Preveleak Surgical sealant is a sealant developed to seal suture holes formed during surgical repair of the circulatory system and to reinforce sutured anastomoses.
Baxter Healthcare Corporation
ADS201810
Not in Commercial Distribution

  • 25413765583609 ()
  • 05413765583605 ()
ADS201810

  • Surgical internal adhesive/sealant, animal-derived
Preveleak Surgical sealant is a sealant developed to seal suture holes formed during surgical repair of the circulatory system and to reinforce sutured anastomoses.
Baxter Healthcare Corporation
ADS201809
Not in Commercial Distribution

  • 25413765583593 ()
  • 05413765583599 ()
ADS201809

  • Surgical internal adhesive/sealant, animal-derived
Preveleak Surgical sealant is a sealant developed to seal suture holes formed during surgical repair of the circulatory system and to reinforce sutured anastomoses
Baxter Healthcare Corporation
ADS201808
In Commercial Distribution

  • 25413765583586 ()
  • 05413765583582 ()
ADS201808

  • Surgical internal adhesive/sealant, animal-derived
Foldable, posterior chamber intraocular lens (IOL), preloaded in an injector that automatically folds the lens as it is advanced, prior to insertion. Single use.
HOYA MEDICAL SINGAPORE PTE. LTD.
PREVUE (yellow), +27.50D
In Commercial Distribution

  • 10757770564757 ()


  • Posterior-chamber intraocular lens, pseudophakic
Foldable, posterior chamber intraocular lens (IOL), preloaded in an injector that automatically folds the lens as it is advanced, prior to insertion. Single use.
HOYA MEDICAL SINGAPORE PTE. LTD.
PREVUE (yellow), +27.00D
In Commercial Distribution

  • 10757770564740 ()


  • Posterior-chamber intraocular lens, pseudophakic
Foldable, posterior chamber intraocular lens (IOL), preloaded in an injector that automatically folds the lens as it is advanced, prior to insertion. Single use.
HOYA MEDICAL SINGAPORE PTE. LTD.
PREVUE (yellow), +26.50D
In Commercial Distribution

  • 10757770564733 ()


  • Posterior-chamber intraocular lens, pseudophakic
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