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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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OARM BI70000028120 USED SYS 120V ENGLISH
MEDTRONIC NAVIGATION, INC.
BI70000028120
In Commercial Distribution

  • 00643169625228 ()


  • Portable general-purpose fluoroscopic x-ray system, digital
OARM BI70000028120R SYS 120V ENGLISH RWK
MEDTRONIC NAVIGATION, INC.
BI70000028120R
In Commercial Distribution

  • 00643169589292 ()


  • Portable general-purpose fluoroscopic x-ray system, digital
FINAL ASSY - LP500, ENGLISH,NO VOICE
PHYSIO-CONTROL, INC.
99401
Not in Commercial Distribution

  • 00681490577441 ()
99401-000042

  • Non-rechargeable public semi-automated external defibrillator
ASSY, PKG, REVEL, GRN, DISS, ENGLISH
Carefusion Corporation
19260-001
Not in Commercial Distribution

  • 00845873000029 ()
19260-001; 19260-001-99

  • Transport electric ventilator
ASSY, PKG, ENVE, GRN, DISS, ENGLISH
Carefusion Corporation
19250-001
Not in Commercial Distribution

  • 00845873000005 ()


  • Transport electric ventilator
Power Control Console 2, English Voice
OSTEOMED LLC
450-0021-01
In Commercial Distribution

  • 00845694012164 ()
450-0021-01

  • General internal orthopaedic fixation system implantation kit
CUSTOM SOUND SUITE 3.2 ENGLISH (US)
COCHLEAR LIMITED
Z274923
In Commercial Distribution

  • 09321502020480 ()
Z274923

  • Audiometric/hearing device software
CUSTOM SOUND SUITE 3.1 ENGLISH (US)
COCHLEAR LIMITED
Z248940
In Commercial Distribution

  • 09321502019873 ()
Z248940

  • Audiometric/hearing device software
CUSTOM SOUND SUITE 3.0 US ENGLISH
COCHLEAR LIMITED
Z220129
In Commercial Distribution

  • 09321502018906 ()
Z220129

  • Audiometric/hearing device software
English Plantain -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386168
In Commercial Distribution

  • 00630414965499 ()
W9L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
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