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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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No Description
AXELGAARD MANUFACTURING CO., LTD.
USX2000
In Commercial Distribution

  • 00856817005819 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable
Robotic Exoscope
Synaptive Medical Inc
SYN-0974
In Commercial Distribution

  • 00670082000573 ()


  • General-purpose surgical microscope
Robotic Exoscope
Synaptive Medical Inc
SYN-0976
In Commercial Distribution

  • 00670082000566 ()


  • General-purpose surgical microscope
The PlasmaFlow X is intended to be an easy to use sequential compression system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to: Aid in the prevention of DVT Enhance blood circulation Diminish post-operative pain and swelling Reduce wound healing time Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.
Manamed, Inc.
XPF0001
In Commercial Distribution

  • 00850998008478 ()
XPF0001

  • Intermittent venous compression system
Constriction Ring
AUGUSTA MEDICAL SYSTEMS, L.L.C.
Constriction Ring
In Commercial Distribution

  • 00852598007219 ()


  • Penile vacuum device
PALS X 2" x 4" rectangle
AXELGAARD MANUFACTURING CO., LTD.
PX2040
In Commercial Distribution

  • 00851913006418 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable
PALS X 2" x 2" square
AXELGAARD MANUFACTURING CO., LTD.
PX2020
In Commercial Distribution

  • 00851913006401 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable
Ultrasound Doppler Device (Doppler-Box X1)
Compumedics Germany GmbH
DBX1
In Commercial Distribution

  • 04260493310765 ()
7780

  • Invasive vascular ultrasound system
  • Noninvasive vascular ultrasound system, line-powered
Ultrasound Doppler Device
Compumedics Germany GmbH
DBX
In Commercial Distribution

  • 04260493310055 ()
7750

  • Noninvasive vascular ultrasound system, line-powered
  • Invasive vascular ultrasound system
No Description
VIOL Co.,Ltd.
SYLFIRM X
In Commercial Distribution

  • 08809502330101 ()


  • Electrosurgical system
5-LEVEL SAPPHIRE X® CERVICAL PLATE, 110MM
SPINAL ELEMENTS, INC.
27005-110
In Commercial Distribution

  • 00840606169752 ()


  • Spinal fixation plate, non-bioabsorbable
5-LEVEL SAPPHIRE X® CERVICAL PLATE, 105MM
SPINAL ELEMENTS, INC.
27005-105
In Commercial Distribution

  • 00840606169707 ()


  • Spinal fixation plate, non-bioabsorbable
5-LEVEL SAPPHIRE X® CERVICAL PLATE, 95MM
SPINAL ELEMENTS, INC.
27005-095
In Commercial Distribution

  • 00840606169608 ()


  • Spinal fixation plate, non-bioabsorbable
5-LEVEL SAPPHIRE X® CERVICAL PLATE, 90MM
SPINAL ELEMENTS, INC.
27005-090
In Commercial Distribution

  • 00840606169554 ()


  • Spinal fixation plate, non-bioabsorbable
4-LEVEL SAPPHIRE X® CERVICAL PLATE, 64MM
SPINAL ELEMENTS, INC.
27004-064
In Commercial Distribution

  • 00840606169080 ()


  • Spinal fixation plate, non-bioabsorbable
4-LEVEL SAPPHIRE X® CERVICAL PLATE, 60MM
SPINAL ELEMENTS, INC.
27004-060
In Commercial Distribution

  • 00840606169042 ()


  • Spinal fixation plate, non-bioabsorbable
4-LEVEL SAPPHIRE X® CERVICAL PLATE, 56MM
SPINAL ELEMENTS, INC.
27004-056
In Commercial Distribution

  • 00840606169004 ()


  • Spinal fixation plate, non-bioabsorbable
4-LEVEL SAPPHIRE X® CERVICAL PLATE, 52MM
SPINAL ELEMENTS, INC.
27004-052
In Commercial Distribution

  • 00840606168960 ()


  • Spinal fixation plate, non-bioabsorbable
3-LEVEL SAPPHIRE X® CERVICAL PLATE, 63MM
SPINAL ELEMENTS, INC.
27003-063
In Commercial Distribution

  • 00840606168915 ()


  • Spinal fixation plate, non-bioabsorbable
3-LEVEL SAPPHIRE X® CERVICAL PLATE, 60MM
SPINAL ELEMENTS, INC.
27003-060
In Commercial Distribution

  • 00840606168885 ()


  • Spinal fixation plate, non-bioabsorbable
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