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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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X PRO - 06430035872848

No Description
PaloDEx Group Oy
IOS-1
In Commercial Distribution

  • 06430035872848 ()


  • Dental milling system, CAD/CAM, chairside

SureFit X - 00852598007219

Constriction Ring
AUGUSTA MEDICAL SYSTEMS, L.L.C.
Constriction Ring
In Commercial Distribution

  • 00852598007219 ()


  • Penile vacuum device

LightForce X - 00854103007295

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 - 00851913006418

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 - 00851913006401

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

PlasmaFlow X - 00850998008478

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

UltraStim X - 00856817005871

No Description
AXELGAARD MANUFACTURING CO., LTD.
USX2040-4
Not in Commercial Distribution

  • 00856817005871 ()


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

UltraStim X - 00856817005833

No Description
AXELGAARD MANUFACTURING CO., LTD.
USX2040
In Commercial Distribution

  • 00856817005833 ()


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

UltraStim X - 00856817005826

No Description
AXELGAARD MANUFACTURING CO., LTD.
USX2020
In Commercial Distribution

  • 00856817005826 ()


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

UltraStim X - 00856817005819

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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