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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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Transmitter
ST. JUDE MEDICAL, INC.
EX1150W
In Commercial Distribution

  • 05415067034809 ()
EX1150W

  • Transtelephonic implantable pacemaker analysis system
Transmitter
ST. JUDE MEDICAL, INC.
EX1150
In Commercial Distribution

  • 05414734504799 ()
EX1150

  • Transtelephonic implantable pacemaker analysis system
Transmitter
ST. JUDE MEDICAL, INC.
EX1100
In Commercial Distribution

  • 05414734504782 ()
EX1100

  • Transtelephonic implantable pacemaker analysis system
The Tunneler is used for subcutaneous placement of the Intrathecal Catheter. It is a sterile, malleable stainless steel tunneler with a pointed tip to penetrate subcutaneous tissue and a threaded end for attachment to the Intrathecal Catheter.
Flowonix Medical, Inc.
11826
In Commercial Distribution

  • 00810335020150 ()


  • Subcutaneous tunneller, single-use
The Physician Configuration Device is used to configure the Patient Therapy Controller for proper use with a single Programmable Pump. It can also be used to read historical data and error logs from the Patient Therapy Controller.
Flowonix Medical, Inc.
12861
In Commercial Distribution

  • 00810335020181 ()


  • Infusion pump programmer
HEADFRAME PFK TYPE 1.1 FDA/ROW INTEGRA (FMI). Multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment. These are the upgrade kits for Integra headframes to allow compatibility with Insightec-made PFK
INSIGHTEC LTD
SET400168-AE PFK TYPE 1.1 FDA/ROW INTEGRA (FMI)
In Commercial Distribution

  • 07290019402466 ()
SET400168-AE

  • Therapeutic oncological/gynaecological ultrasound system
HEADFRAME PFK TYPE 1.0 FDA/ROW INTEGRA (FMI). Multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment. These are the upgrade kits for Integra headframes to allow compatibility with Insightec-made PFK
INSIGHTEC LTD
SET400168-AD PFK TYPE 1.0 FDA/ROW INTEGRA (FMI)
In Commercial Distribution

  • 07290019402442 ()
SET400168-AD

  • Therapeutic oncological/gynaecological ultrasound system
Paragon RG-4 contact lenses are manufactured from Paragon HDS® 100. The reverse geometry design has a posterior surface consisting of four zones: The central spherical or aspheric zone, an annular “Reverse Zone(s)”surrounding the central zone with a curvature steeper (shorter radius) than the central zone, an “Alignment Zone(s)” generally paralleling the underlying corneal surface and peripheral curve(s) with a radius selected to create “edge lift” to promote tear flow under the lens and avoid impingement of the peripheral curve on the cornea. The lens design also includes a “rounded” edge terminus extending from the anterior to the posterior surfaces to promote comfort. Paragon RG-4 Contact Lenses for Corneal Reshaping are to be worn overnight with removal during all or part of each following day. The material is a thermoset fluorosilicone acrylate copolymer derived primarily from siloxane acrylate, trifluoroethyl methacrylate and methylmethacrylate with a water content of less than 1%. These contact lenses for corneal reshaping are available as lathe cut firm contact lenses with blue, green, red and yellow tints containing D&C Green No. 6, D&C Red No. 17 and Perox Yellow No. 9 (4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one). These products may be plasma treated.
Paragon Vision Sciences, Inc.
Paragon RG-4
In Commercial Distribution

  • B22220 ()


  • Orthokeratology contact lens
LimFlow Extension Stent Graft (5.5 mm x 200 mm). The LimFlow Extension Stent Graft is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
RGS-55200-US-24
In Commercial Distribution

  • 00850041730219 ()


  • Arteriovenous endovascular stent-graft
LimFlow Extension Stent Graft (5.5 mm x 150 mm). The LimFlow Extension Stent Graft is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
RGS-55150-US-24
In Commercial Distribution

  • 00850041730202 ()


  • Arteriovenous endovascular stent-graft
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