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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
PaloDEx Group Oy
IOS-1
In Commercial Distribution

  • 06430035872848 ()


  • Dental milling system, CAD/CAM, chairside
Constriction Ring
AUGUSTA MEDICAL SYSTEMS, L.L.C.
Constriction Ring
In Commercial Distribution

  • 00852598007219 ()


  • Penile vacuum device
Infrared phototherapy device emitting up to 10 W at 810/980 nm, 7" display
LITECURE LLC
LTC-1001-L-B6
In Commercial Distribution

  • 00854103007295 ()


  • Musculoskeletal/physical therapy laser, professional
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
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
No Description
AXELGAARD MANUFACTURING CO., LTD.
USX2040-4
Not in Commercial Distribution

  • 00856817005871 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable
No Description
AXELGAARD MANUFACTURING CO., LTD.
USX2040
In Commercial Distribution

  • 00856817005833 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable
No Description
AXELGAARD MANUFACTURING CO., LTD.
USX2020
In Commercial Distribution

  • 00856817005826 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable
No Description
AXELGAARD MANUFACTURING CO., LTD.
USX2000
In Commercial Distribution

  • 00856817005819 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable
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