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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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Indego Therapy is a computerized, adjustable-fit powered exoskeleton, designed to restore walking function for impaired individuals.
Ekso Bionics, Inc.
501-110-001
In Commercial Distribution

  • B168501110001 ()


  • Programmable ambulation exoskeleton, clinical
Grandio® Seal is a light-curing, highly filled, fluoride-containing nanohybrid fissure sealant with outstanding mechanical properties.
VOCO GmbH
1061
In Commercial Distribution

  • E22110611 ()
  • E2211061 ()
1061

  • Dental unfilled resin sealant/coating
Grandio® Seal is a light-curing, highly filled, fluoride-containing nanohybrid fissure sealant with outstanding mechanical properties.
VOCO GmbH
1060
In Commercial Distribution

  • E22110601 ()
  • E2211060 ()
1060

  • Dental unfilled resin sealant/coating
The Vest Holder is intended to be used to limit the movement of the patient's body.
Kenad SG Medical, Inc.
Protective Vest No Sleeve Xlarge
Not in Commercial Distribution

  • M1435040070 ()
50-4007

  • Limb/torso/head restraint, single-use
The Vest Holder is intended to be used to limit the movement of the patient's body.
Kenad SG Medical, Inc.
Protective Vest No Sleeve Large
Not in Commercial Distribution

  • M1435040060 ()
50-4006

  • Limb/torso/head restraint, single-use
The Vest Holder is intended to be used to limit the movement of the patient's body.
Kenad SG Medical, Inc.
Protective Vest No Sleeve Medium
Not in Commercial Distribution

  • M1435040050 ()
50-4005

  • Limb/torso/head restraint, single-use
The Vest Holder is intended to be used to limit the movement of the patient's body.
Kenad SG Medical, Inc.
Protective Vest No Sleeve Small
Not in Commercial Distribution

  • M1435040040 ()
50-4004

  • Limb/torso/head restraint, single-use
The waist holder is intended to be used to limit the movement of the patient's body.
Kenad SG Medical, Inc.
Patient Protective Waist Holder w/slit
Not in Commercial Distribution

  • M1435036000 ()
50-3600

  • Limb/torso/head restraint, single-use
The waist holder is intended to be used to limit the movement of the patient's body.
Kenad SG Medical, Inc.
Patient Protective Waist Holder Adult
Not in Commercial Distribution

  • M1435035000 ()
50-3500

  • Limb/torso/head restraint, single-use
The Waist Holder is intended to be used to limit the movement of the patient's body.
Kenad SG Medical, Inc.
Universal Waist Holder Pediatric
Not in Commercial Distribution

  • M1435034000 ()
50-3400

  • Limb/torso/head restraint, single-use
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