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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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Atalante X - 03665965000129

The Atalante X by Wandercraft is a completely self-balancing walking system for people with mobility disabilities. It is a fully powered hip-knee-ankle lower body exoskeleton with 12 actuated degrees of freedom. Atalante X is self-balancing and includes dynamic-walking control. Dynamic walking allows the Atalante X to consume significantly less power and have a more natural gait. The Atalante X is a tool for physical therapy. It is meant to be highly adjustable and be applicable for various stages of physical rehabilitation, re-mobilization and exercises.
WANDERCRAFT
ATA-002-EN US
In Commercial Distribution

  • 03665965000129 ()


  • Programmable ambulation exoskeleton, clinical

Breather X - 01240000013849

No Description
Pn Medical Inc
1
In Commercial Distribution

  • 01240000013849 ()


  • Tongue/lip exerciser

FlexLab X - 07640172344002

The FlexLab X automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The system consolidates multiple Analytical instruments into a unified workstation.
Inpeco SA
FXX
In Commercial Distribution

  • 07640172344002 ()


  • Specimen processing instrument IVD

OptiCross X - 08714729893264

Coronary Imaging Catheter
BOSTON SCIENTIFIC CORPORATION
H74939405030
Not in Commercial Distribution

  • 08714729893264 ()

  • 3.0 F Diameter
  • 135 cm Effective Length
  • 1.00 mm Diameter


  • Intravascular ultrasound imaging catheter, single-use

SAPPHIRE X - 00840606163545

2-LEVEL SAPPHIRE X® CERVICAL PLATE, 32MM
SPINAL ELEMENTS, INC.
27002-032
In Commercial Distribution

  • 00840606163545 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606163521

2-LEVEL SAPPHIRE X® CERVICAL PLATE, 28MM
SPINAL ELEMENTS, INC.
27002-028
In Commercial Distribution

  • 00840606163521 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606163491

2-LEVEL SAPPHIRE X® CERVICAL PLATE, 22MM
SPINAL ELEMENTS, INC.
27002-022
In Commercial Distribution

  • 00840606163491 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606163484

2-LEVEL SAPPHIRE X® CERVICAL PLATE, 20MM
SPINAL ELEMENTS, INC.
27002-020
In Commercial Distribution

  • 00840606163484 ()


  • Spinal fixation plate, non-bioabsorbable

SAPPHIRE X - 00840606162340

SAPPHIRE X® SINGLE LEVEL INSERTER, INTERNAL SHAFT, LONG
SPINAL ELEMENTS, INC.
27010-003-02
In Commercial Distribution

  • 00840606162340 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SAPPHIRE X - 00840606162296

SAPPHIRE X® SINGLE LEVEL INSERTER, SHORT
SPINAL ELEMENTS, INC.
27010-001
In Commercial Distribution

  • 00840606162296 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
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