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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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GALILEOS Hardware Comfort PLUS
SIRONA Dental Systems GmbH
6299999
Not in Commercial Distribution

  • E27662999990 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
InMode system - new hardware
INMODE M.D LTD
AG606666A
In Commercial Distribution

  • 07290016633252 ()
AG606666A

  • Multi-modality skin surface treatment system
SMART TSF HARDWARE CASE
Smith & Nephew, Inc.
71075502
In Commercial Distribution

  • 00885556746264 ()
71075502

  • Instrument tray, reusable
HARDWARE 9731838 POLESTAR INTEGRATION
MEDTRONIC NAVIGATION, INC.
9731838
In Commercial Distribution

  • 00885074366722 ()


  • Extremity MRI system, permanent magnet
SPATIAL FRAME HARDWARE CASE
Smith & Nephew, Inc.
71070380
In Commercial Distribution

  • 00885556012963 ()
71070380

  • Instrument tray, reusable
mTrigger Biofeedback System
MTRIGGER, LLC
BI2612/BK2613
In Commercial Distribution

  • 00863712000337 ()


  • Biomechanical function analysis/interactive rehabilitation system
BIODEX SYSTEM 3 REMANUFACTURE
BIODEX MEDICAL SYSTEMS, INC.
850-820
Not in Commercial Distribution

  • 00718175004050 ()
850-820

  • Biomechanical function analysis/interactive rehabilitation system
A portable measurement system for quantifying musculoskeletal strength and range of motion. Various EV versions are available that are different configurations of the same medical device model.
BTE TECHNOLOGIES, INC.
Evaluator EV
Not in Commercial Distribution

  • 10850390007373 ()


  • Biomechanical function analysis system, force-testing, portable
A portable measurement system for quantifying musculoskeletal strength and range of motion.
BTE TECHNOLOGIES, INC.
Evaluator EVJ
In Commercial Distribution

  • 10850390007366 ()


  • Biomechanical function analysis system, force-testing, portable
No Description
BTE TECHNOLOGIES, INC.
EV2
Not in Commercial Distribution

  • 10850390007342 ()


  • Biomechanical function analysis system, force-testing, portable
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