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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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PROMUS Element™ Plus - 08714729807766

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911416220
Not in Commercial Distribution

  • 08714729807766 ()

  • 2.25 mm Stent Diameter
  • 16 mm Stent Length
H7493911416220

  • Coronary angioplasty balloon catheter, basic
  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated

PROMUS Element™ Plus - 08714729807759

Everolimus-Eluting Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493911412220
Not in Commercial Distribution

  • 08714729807759 ()

  • 2.25 mm Stent Diameter
  • 12 mm Stent Length
H7493911412220

  • Coronary angioplasty balloon catheter, basic
  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated

OBALON® - 00859810006227

OBALON® Navigation Balloon System - contains one OBALON® Navigation Balloon Kit and one OBALON® Accessory Kit - Ejectors
ReShape Lifesciences Inc.
9410-0001
Not in Commercial Distribution

  • 10859810006224 ()
  • 00859810006227 ()


  • Appetite-suppression gastric balloon deployment device/set
  • Appetite-suppression gastric balloon

ISPAN SF6 Intraocular Gas - 10860113000116

ISPAN Sulfur Hexafluoride (SF6) is a liquified gas under pressure and is administered by injection into the vitreous cavity. It is a colorless, odorless, non-toxic, non-flammable gas. The boiling point is -63.9°C (-83°F) and the vapor pressure at 20°C is 320 psig (pounds per square inch gauge). ISPAN SF6 purity: sulfur hexafluoride 99.99% (minimum), air 100 ppm (maximum), carbon tetrafluoride 100 ppm (maximum), and hydrogen fluoride 0.3 ppm (maximum).
ESCALON MEDICAL CORP.
20 g Cylinder
In Commercial Distribution

  • 10860113000116 ()
  • 00860113000119 ()
  • 20860113000113 ()
TR9088

  • Vitreous/aqueous humour replacement medium, intraoperative

Exair - 05708932459457

Prolapse Repair System - Anterior
Coloplast A/S
50100
In Commercial Distribution

  • 05708932459457 ()
50100

  • Suturing unit, single-use
  • Female stress urinary incontinence surgical mesh-sling, synthetic polymer

Exair - 05708932459433

Prolapse Repair System - Posterior
Coloplast A/S
50150
In Commercial Distribution

  • 05708932459433 ()
50150

  • Suturing unit, single-use
  • Female stress urinary incontinence surgical mesh-sling, synthetic polymer

REBEL™ - 08714729844501

Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493927528450
In Commercial Distribution

  • 08714729844501 ()

  • 28 mm Stent Length
  • 4.50 mm Stent Diameter
H7493927528450

  • Bare-metal coronary artery stent
  • Coronary angioplasty balloon catheter, basic

REBEL™ - 08714729844464

Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493927528270
In Commercial Distribution

  • 08714729844464 ()

  • 2.75 mm Stent Diameter
  • 28 mm Stent Length
H7493927528270

  • Coronary angioplasty balloon catheter, basic
  • Bare-metal coronary artery stent

REBEL™ - 08714729844433

Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493927524450
In Commercial Distribution

  • 08714729844433 ()

  • 4.50 mm Stent Diameter
  • 24 mm Stent Length
H7493927524450

  • Coronary angioplasty balloon catheter, basic
  • Bare-metal coronary artery stent

REBEL™ - 08714729844402

Platinum Chromium Coronary Stent System
BOSTON SCIENTIFIC CORPORATION
H7493927524300
In Commercial Distribution

  • 08714729844402 ()

  • 24 mm Stent Length
  • 3.00 mm Stent Diameter
H7493927524300

  • Coronary angioplasty balloon catheter, basic
  • Bare-metal coronary artery stent
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