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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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STENT ENSP35024WENDEAVORSPRINT3.50X24OTW
MEDTRONIC, INC.
ENSP35024W
Not in Commercial Distribution

  • 00613994539618 ()

  • Stent Inner Diameter 3.5 MM
  • Length: 24.0 Millimeter


  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
STENT ENSP35030UX ENDEAVORSPRINT3.50X30X
MEDTRONIC, INC.
ENSP35030UX
Not in Commercial Distribution

  • 00613994539601 ()

  • Length: 30.0 Millimeter
  • Stent Inner Diameter 3.5 MM


  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
STENT ENSP35030WENDEAVORSPRINT3.50X30OTW
MEDTRONIC, INC.
ENSP35030W
Not in Commercial Distribution

  • 00613994539595 ()

  • Stent Inner Diameter 3.5 MM
  • Length: 30.0 Millimeter


  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
Hemostatic agent, including thrombin
DILON TECHNOLOGIES FRANCE
BQF02
In Commercial Distribution

  • 03760193182705 ()
  • 13760193182702 ()

  • Weight: 1.65 Gram
BQF02-US

  • Collagen haemostatic agent, non-antimicrobial
The Spatz3 Adjustable Balloon System is indicated for temporary use for weight loss in adults with obesity Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with one or more major obesity-related comorbid conditions who have failed to achieve and maintain weight-loss with a supervised weight control program. The Spatz3 Adjustable Balloon System is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of long-term weight-loss maintenance. The maximum placement period for Spatz3 Adjustable Balloon System is 8 months.
SPATZ FGIA (ISRAEL) LTD
A-SP3US-03K
In Commercial Distribution

  • 00860005178803 ()


  • Appetite-suppression gastric balloon
WAVELIGHT TOPOLYZER VARIO: The WaveLight® Topolyzer™ VARIO and WaveLight® Analyzer II diagnostic devices are measuring instruments intended for use in eye examinations to measure corneal topography. Data from these systems may be exported and used to support refractive surgical procedures with the WaveLight® laser systems.
Alcon Laboratories, Inc.
8065990767
In Commercial Distribution

  • 00380659907678 ()

  • Weight: 70.4 Pound


  • Corneal topography system
ALLEGRO ANALYZER. The WaveLight® Topolyzer™ VARIO and WaveLight® Analyzer II diagnostic devices are measuring instruments intended for use in eye examinations to measure corneal topography. Data from these systems may be exported and used to support refractive surgical procedures with the WaveLight® laser systems.
Alcon Laboratories, Inc.
8065990606
Not in Commercial Distribution

  • 00380659906060 ()

  • Weight: 188 Pound


  • Corneal topography system
The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required. The TriVascular Ovation Prime Abdominal Stent Graft System includes, an Aortic Body Stent Graft and delivery catheter, Iliac Limb Stent Grafts and delivery catheters, Iliac Extension Stent Grafts and delivery catheters, as required, a Fill Polymer Kit, and an Autoinjector.
Trivascular, Inc.
Iliac Limb
In Commercial Distribution

  • M701TVIL1418120E1 ()

  • Catheter Gauge: 14 French
  • Length: 120 Millimeter
  • Outer Diameter: 18 Millimeter
  • Outer Diameter: 14 Millimeter
TV-IL1418120-E

  • Abdominal aorta endovascular stent-graft
No Description
RAYNER INTRAOCULAR LENSES LIMITED
970C
Not in Commercial Distribution

  • 05029867803468 ()
970C/+31.0

  • Posterior-chamber intraocular lens, pseudophakic
Implantable Pulse Generator
ST. JUDE MEDICAL, INC.
7
In Commercial Distribution

  • 05415067030023 ()
6662

  • Deep brain electrical stimulation system
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