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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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GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100043-11
Not in Commercial Distribution

  • 00810054980094 ()

  • Length: 10.2 Centimeter
  • Height: 2.5 Centimeter
FR3D11

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100043-10
Not in Commercial Distribution

  • 00810054980087 ()

  • Height: 2.5 Centimeter
  • Length: 7.6 Centimeter
FR3D10

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100043-09
Not in Commercial Distribution

  • 00810054980070 ()

  • Length: 7.6 Centimeter
  • Height: 2.5 Centimeter
FR3D09

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100043-07
Not in Commercial Distribution

  • 00810054980063 ()

  • Height: 7.6 Centimeter
  • Length: 20.3 Centimeter
FR3D07

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
SafeBreak Vascular is a Force-Activated Separation Device. It is intended to separate when excessive tension is exerted across a peripheral IV administration set. When SafeBreak Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient’s IV catheter. SafeBreak Vascular is intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement. SafeBreak Vascular is intended to be used on peripheral IV catheters in adults and adolescent populations eighteen (18) years of age and older receiving intermittent or continuous infusions with an electronic pump.
Lineus Medical
A
In Commercial Distribution

  • 10860635000311 ()
2855-01-0001

  • Luer/Luer breakaway connector
Surgical Probe Kit
NEUWAVE MEDICAL, INC.
PRSURGKT
Not in Commercial Distribution

  • 00853719006531 ()
PRSURGKT

  • Microwave ablation system probe, non-powered
Dual Resection Probe Clip
NEUWAVE MEDICAL, INC.
RC17PK
Not in Commercial Distribution

  • 00853719006548 ()
  • 00853719006494 ()
RC17PK

  • Microwave ablation system probe, non-powered
NEUWAVE Surgical Tool
NEUWAVE MEDICAL, INC.
CSURG
Not in Commercial Distribution

  • 00853719006449 ()
CSURG

  • Microwave ablation system probe, non-powered
NEUWAVE SR Probe 25CM 13ga
NEUWAVE MEDICAL, INC.
NWSR25
In Commercial Distribution

  • 00853719006432 ()
  • 10853719006439 ()
NWSR25

  • Microwave ablation system probe, non-powered
NEUWAVE PR XT Probe 20CM 15ga
NEUWAVE MEDICAL, INC.
PR20XT
In Commercial Distribution

  • 00853719006425 ()
  • 10853719006422 ()
PR20XT

  • Microwave ablation system probe, non-powered
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