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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 GRAFT ETEW1010C82E ENDUR II ILEXT
MEDTRONIC, INC.
ETEW1010C82E
In Commercial Distribution

  • 00613994991379 ()

  • Stent Graft Proximal Diameter 10 MM
  • Stent Graft Covered Length 82 MM
  • Stent Graft Distal Diameter 10 MM


  • Abdominal aorta endovascular stent-graft
STENT GRAFT ETLW1628C199E ENDUR II LIMB
MEDTRONIC, INC.
ETLW1628C199E
Not in Commercial Distribution

  • 00613994991362 ()

  • Stent Graft Proximal Diameter 16 MM
  • Stent Graft Covered Length 199 MM
  • Stent Graft Distal Diameter 28 MM


  • Abdominal aorta endovascular stent-graft
Multi-Trauma Dressing, Sterile, 10"x30"
Dynarex Corporation
3531
In Commercial Distribution

  • 00616784353135 ()
  • 00616784353111 ()


  • Pressure bandage, non-latex, single-use
Dermagraft is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than six weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure. Dermagraft should be used in conjunction with standard wound care regimens and in patients that have adequate blood supply to the involved foot.
ORGANOGENESIS INC.
1
In Commercial Distribution

  • 00618474000015 ()


  • Skin regeneration template, human-/animal-derived
Apligraf is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full thickness skin ulcers due to venous insufficience of greater than one month duration and which have not adequately responded to conventional ulcer therapy. Apligraf is also indicated for use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than three weeks duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
ORGANOGENESIS INC.
1
In Commercial Distribution

  • 00618474000008 ()


  • Skin regeneration template, human-/animal-derived
TRANSCYTE® is a human fibroblast-derived temporary skin substitute consisting of a polymer membrane and donated neonatal human fibroblast cells cultured under aseptic conditions in vitro on a nylon mesh. Prior to cell growth, this nylon mesh is coated with porcine dermal collagen and bonded to a polymer membrane (silicone). This membrane provides a transparent synthetic epidermis when applied. As fibroblasts proliferate within the nylon mesh, they secrete human dermal collagen, matrix proteins and growth factors. Following freezing, no cellular metabolic activity remains; however, the tissue matrix and bound growth factors are left intact. The human fibroblast-derived temporary skin substitute provides a temporary protective barrier. TRANSCYTE is transparent and allows direct visual monitoring of the wound bed.
ORGANOGENESIS INC.
10633
In Commercial Distribution

  • 00618474000046 ()


  • Skin regeneration template, human-/animal-derived
Smooth Moderate High Profile, 435cc |Smooth|Round|Silicone|
MENTOR TEXAS L.P.
SMHB435
In Commercial Distribution

  • 10081317031113 ()
SMHB-435

  • Silicone gel-filled breast implant, smooth-surface
Saline Breast Implant, 300cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3501645D
In Commercial Distribution

  • 10081317030635 ()
350-1645D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 250cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3501635D
In Commercial Distribution

  • 10081317030611 ()
350-1635D

  • Saline-filled breast implant, unstructured, smooth-surface
Saline Breast Implant, 225cc |Smooth|Round|Saline|
MENTOR TEXAS L.P.
3501630D
In Commercial Distribution

  • 10081317030604 ()
350-1630D

  • Saline-filled breast implant, unstructured, smooth-surface
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