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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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EVERFLO w/O2 Percentage Indicator, 120V US, BRAZIL
Respironics, Inc.
EVERFLO w/O2 Percentage Indicator, 120V US, BR
In Commercial Distribution

  • 00606959032750 ()
1020002BR

  • Stationary oxygen concentrator
PillCam™ WS, v9 USA
Given Imaging, Inc.
FGS-0674
In Commercial Distribution

  • 07290110361167 ()


  • Video capsule endoscopy system application software
No Description
OSADA ELECTRIC CO.,LTD.
EXL-M40
In Commercial Distribution

  • 04580406860478 ()
3223

  • Dental laboratory power tool system
  • Line-powered dental drilling system
  • Dental power tool system, line-powered
No Description
OSADA ELECTRIC CO.,LTD.
XL-230
In Commercial Distribution

  • 04580406860461 ()
3192

  • Dental power tool system, line-powered
  • Dental laboratory power tool system
  • Line-powered dental drilling system
No Description
ALIMED, INC.
931720
In Commercial Distribution

  • 00733657239744 ()
2970013381

  • Freestanding patient positioner, reusable
No Description
ALIMED, INC.
925480
In Commercial Distribution

  • 00733657238884 ()
  • 00733657299380 ()
2970012634

  • Freestanding patient positioner, single-use
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-084-009-005
In Commercial Distribution

  • 00858092006956 ()
00-084-009-005

  • General-purpose centrifuge IVD
No Description
HARD MANUFACTURING CO., INC.
1711-BFP
In Commercial Distribution

  • 00852231007552 ()
  • 00852231007545 ()
1711-BFP

  • Paediatric bed
No Description
JACE MEDICAL, LLC
115.407.24
Not in Commercial Distribution

  • 00851599007976 ()


  • Orthopaedic fixation plate, non-bioabsorbable
No Description
Hasa Optix
HA-SET024
In Commercial Distribution

  • 05404027446745 ()
  • 05404027444727 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
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