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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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USB,FSW SM2.1,SP1,US,UP1
Gn Hearing A/S
23669300
In Commercial Distribution

  • 05708296384945 ()


  • Audiometric/hearing device software
USB,FSW SF2.1,AV3,US,UP1
Gn Hearing A/S
23669100
In Commercial Distribution

  • 05708296384921 ()


  • Audiometric/hearing device software
USB,FSW AG3.1,AG1,US,UP1
Gn Hearing A/S
23668700
In Commercial Distribution

  • 05708296384884 ()


  • Audiometric/hearing device software
SW,FSW XE BEMORE 2.1,UP1
Gn Hearing A/S
23668500
In Commercial Distribution

  • 05708296384860 ()


  • Audiometric/hearing device software
SW,FSW SOLUS MAX 2.1,UP1
Gn Hearing A/S
23668400
In Commercial Distribution

  • 05708296384853 ()


  • Audiometric/hearing device software
SW,FSW SMART FIT 2.1,UP1
Gn Hearing A/S
23668200
In Commercial Distribution

  • 05708296384839 ()


  • Audiometric/hearing device software
SW,FSW CS SMART FIT 2.1,UP1
Gn Hearing A/S
23667800
In Commercial Distribution

  • 05708296384792 ()


  • Audiometric/hearing device software
SW,FSW AUDIGY 3.1,UP1
Gn Hearing A/S
23667700
In Commercial Distribution

  • 05708296384785 ()


  • Audiometric/hearing device software
SW,FSW SMART FIT 2.1
Gn Hearing A/S
23509100
In Commercial Distribution

  • 05708296368969 ()


  • Audiometric/hearing device software
DVD,FSW SF2.1,AV3,VA
Gn Hearing A/S
23508300
In Commercial Distribution

  • 05708296368884 ()


  • Audiometric/hearing device software
USB,FSW XB2.0,US,UP1
Gn Hearing A/S
23372900
In Commercial Distribution

  • 05708296367856 ()


  • Audiometric/hearing device software
USB,FSW SM2.0,SP1,US,UP1
Gn Hearing A/S
23372700
In Commercial Distribution

  • 05708296367832 ()


  • Audiometric/hearing device software
USB,FSW SF2.0,AV3,US,UP1
Gn Hearing A/S
23372500
In Commercial Distribution

  • 05708296367818 ()


  • Audiometric/hearing device software
USB,FSW AG3.0,AG1,US,UP1
Gn Hearing A/S
23372100
In Commercial Distribution

  • 05708296367771 ()


  • Audiometric/hearing device software
SW,FSW XE BEMORE 2.0,UP1
Gn Hearing A/S
23371900
In Commercial Distribution

  • 05708296367757 ()


  • Audiometric/hearing device software
SW,FSW SOLUS MAX 2.0,UP1
Gn Hearing A/S
23371800
In Commercial Distribution

  • 05708296367740 ()


  • Audiometric/hearing device software
SW,FSW SMART FIT 2.0,UP1
Gn Hearing A/S
23371600
In Commercial Distribution

  • 05708296367726 ()


  • Audiometric/hearing device software
SW,FSW CS SMART FIT 2.0,UP1
Gn Hearing A/S
23371200
In Commercial Distribution

  • 05708296367689 ()


  • Audiometric/hearing device software
SW,FSW AUDIGY 3.0,UP1
Gn Hearing A/S
23371100
In Commercial Distribution

  • 05708296367672 ()


  • Audiometric/hearing device software
DVD,FSW SF2.0,AV3,VA,UP1
Gn Hearing A/S
23370800
In Commercial Distribution

  • 05708296367641 ()


  • Audiometric/hearing device software
Genie Medical BAHS 2020.2 VA US, ISO file
Oticon Medical AB
197603
Not in Commercial Distribution

  • 05712149025671 ()
213367

  • Audiometric/hearing device software
Software medical device. Intended for use by professional healthcare providers as an intra-operative image-guidance tool used during surgical and interventional therapy.
Philips Medical Systems Nederland B.V.
ClarifEye - 1
In Commercial Distribution

  • 00884838104570 ()
002120

  • Stereotactic system application software
UroNAV Fusion Biopsy System
Philips DS North America LLC
784001
In Commercial Distribution

  • 00884838083592 ()


  • Stereotactic system application software
UroNAV Fusion Biopsy System
Philips DS North America LLC
784012
In Commercial Distribution

  • 00884838081543 ()


  • Stereotactic system application software
No Description
Edan Instruments, Inc.
MFM-CNS Lite
In Commercial Distribution

  • 06944413807983 ()


  • Obstetrical monitoring/analysis software
SFTW KIT 9735696 STEALTHCONNECT SYS
MEDTRONIC NAVIGATION, INC.
9735696
In Commercial Distribution

  • 00643169705432 ()


  • Stereotactic system application software
WBR Imaging X + X3 + Bone/Xact + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177121 ()


  • SPECT system application software
WBR Imaging X3 + Bone/Xact + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177114 ()


  • SPECT system application software
WBR Imaging X + Bone/Xact + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177107 ()


  • SPECT system application software
WBR Imaging X + X3 + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177091 ()


  • SPECT system application software
WBR Imaging X3 + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177084 ()


  • SPECT system application software
WBR Imaging X + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177077 ()


  • SPECT system application software
WBR Imaging X + X3 + Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177060 ()


  • SPECT system application software
WBR Imaging X3 + Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177053 ()


  • SPECT system application software
WBR Imaging X + Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177046 ()


  • SPECT system application software
WBR Imaging Bone/Xact
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177039 ()


  • SPECT system application software
WBR Imaging X + X3
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177022 ()


  • SPECT system application software
WBR Imaging X3
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177015 ()


  • SPECT system application software
WBR Imaging X
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177008 ()


  • SPECT system application software
Oticon Genie 2 2021.2
Sbo Hearing A/S
228229
In Commercial Distribution

  • 05714464013104 ()


  • Audiometric/hearing device software
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