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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EarQ EAR Q INX5 Hearing Aid
Ws Audiology Usa, Inc.
EAR Q INX5
In Commercial Distribution

  • 04056839085950 ()
10960652

  • Air-conduction hearing aid, in-the-ear
EarQ EAR Q INX3 Hearing Aid
Ws Audiology Usa, Inc.
EAR Q INX3
In Commercial Distribution

  • 04056839085943 ()
10960664

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear ME3500 Hearing Aid
Ws Audiology Usa, Inc.
HA ME3500
In Commercial Distribution

  • 04056839085936 ()
10960239

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear ME5500 Hearing Aid
Ws Audiology Usa, Inc.
HA ME5500
In Commercial Distribution

  • 04056839085929 ()
10960241

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear ME4500 Hearing Aid
Ws Audiology Usa, Inc.
HA ME4500
In Commercial Distribution

  • 04056839085912 ()
10960240

  • Air-conduction hearing aid, in-the-ear
C_ITE INSIO 5NX ITC/HS
Ws Audiology Usa, Inc.
Insio 5Nx ITC
In Commercial Distribution

  • 04056839085639 ()
10956739

  • Air-conduction hearing aid, behind-the-ear
C_ITE INSIO 7NX ITC/HS
Ws Audiology Usa, Inc.
Insio 7Nx ITC
In Commercial Distribution

  • 04056839085622 ()
10956737

  • Air-conduction hearing aid, behind-the-ear
Miracle-Ear S_ITE ME5500 READYFIT L BLK TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE ME5500 READYFIT L BLK TBLU
In Commercial Distribution

  • 04056839084458 ()
10958818

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear S_ITE ME5500 READYFIT R BLK TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE ME5500 READYFIT R BLK TRD
In Commercial Distribution

  • 04056839084441 ()
10958819

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear S_ITE ME5500 READYFIT L MOC TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE ME5500 READYFIT L MOC TBLU
In Commercial Distribution

  • 04056839084434 ()
10958820

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear S_ITE ME5500 READYFIT R MOC TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE ME5500 READYFIT R MOC TRD
In Commercial Distribution

  • 04056839084427 ()
10958821

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear S_ITE ME4500 READYFIT L BLK TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE ME4500 READYFIT L BLK TBLU
In Commercial Distribution

  • 04056839084410 ()
10958822

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear S_ITE ME4500 READYFIT R BLK TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE ME4500 READYFIT R BLK TRD
In Commercial Distribution

  • 04056839084403 ()
10958823

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear S_ITE ME4500 READYFIT L MOC TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE ME4500 READYFIT L MOC TBLU
In Commercial Distribution

  • 04056839084397 ()
10958824

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear S_ITE ME4500 READYFIT R MOC TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE ME4500 READYFIT R MOC TRD
In Commercial Distribution

  • 04056839084380 ()
10958825

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear S_ITE ME3500 READYFIT L BLK TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE ME3500 READYFIT L BLK TBLU
In Commercial Distribution

  • 04056839084373 ()
10958826

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear S_ITE ME3500 READYFIT R BLK TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE ME3500 READYFIT R BLK TRD
In Commercial Distribution

  • 04056839084366 ()
10958827

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear S_ITE ME3500 READYFIT R MOC TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE ME3500 READYFIT R MOC TRD
In Commercial Distribution

  • 04056839084359 ()
10958829

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear S_ITE MEC500 CROS READYFIT L BL TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE MEC500 CROS READYFIT L BL TBLU
In Commercial Distribution

  • 04056839084342 ()
10958830

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear S_ITE MEC500 CROS READYFIT R BL TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE MEC500 CROS READYFIT R BL TRD
In Commercial Distribution

  • 04056839084335 ()
10958831

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear S_ITE MEC500 CROS READYFIT L MO TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE MEC500 CROS READYFIT L MO TBLU
In Commercial Distribution

  • 04056839082195 ()
10958832

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear S_ITE MEC500 CROS READYFIT R MO TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE MEC500 CROS READYFIT R MO TRD
In Commercial Distribution

  • 04056839082188 ()
10958833

  • Air-conduction hearing aid, in-the-ear
Miracle-Ear S_ITE ME3500 READYFIT L MOC TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE ME3500 READYFIT L MOC TBLU
In Commercial Distribution

  • 04056839082126 ()
10958828

  • Air-conduction hearing aid, in-the-ear
Activus HA ACTIVUS LPL P100-S GR Hearing Aid
Ws Audiology Usa, Inc.
HA ACTIVUS LPL P100-S GR
In Commercial Distribution

  • 04056839081006 ()
10955849

  • Air-conduction hearing aid, behind-the-ear
Activus HA ACTIVUS LPL N 312-P BG Hearing Aid
Ws Audiology Usa, Inc.
HA ACTIVUS LPL N 312-P BG
In Commercial Distribution

  • 04056839080955 ()
10955814

  • Air-conduction hearing aid, behind-the-ear
Activus HA ACTIVUS LPL N 312-G BG Hearing Aid
Ws Audiology Usa, Inc.
HA ACTIVUS LPL N 312-G BG
In Commercial Distribution

  • 04056839080948 ()
10955815

  • Air-conduction hearing aid, behind-the-ear
Activus HA ACTIVUS LPL N 312-S BG Hearing Aid
Ws Audiology Usa, Inc.
HA ACTIVUS LPL N 312-S BG
In Commercial Distribution

  • 04056839080931 ()
10955816

  • Air-conduction hearing aid, behind-the-ear
Activus HA ACTIVUS LPL N 312-S DGT Hearing Aid
Ws Audiology Usa, Inc.
HA ACTIVUS LPL N 312-S DGT
In Commercial Distribution

  • 04056839080924 ()
10955817

  • Air-conduction hearing aid, behind-the-ear
Activus HA ACTIVUS LPL N 312-S DKC Hearing Aid
Ws Audiology Usa, Inc.
HA ACTIVUS LPL N 312-S DKC
In Commercial Distribution

  • 04056839080917 ()
10955818

  • Air-conduction hearing aid, behind-the-ear
Activus HA ACTIVUS LPL N 312-S GR Hearing Aid
Ws Audiology Usa, Inc.
HA ACTIVUS LPL N 312-S GR
In Commercial Distribution

  • 04056839080900 ()
10955819

  • Air-conduction hearing aid, behind-the-ear
Activus HA ACTIVUS LPL N 312-G DKC Hearing Aid
Ws Audiology Usa, Inc.
HA ACTIVUS LPL N 312-G DKC
In Commercial Distribution

  • 04056839080894 ()
10955820

  • Air-conduction hearing aid, behind-the-ear
Activus HA ACTIVUS LPL N 312-G DGT Hearing Aid
Ws Audiology Usa, Inc.
HA ACTIVUS LPL N 312-G DGT
In Commercial Distribution

  • 04056839080887 ()
10955821

  • Air-conduction hearing aid, behind-the-ear
Activus HA ACTIVUS LPL N 312-G GR Hearing Aid
Ws Audiology Usa, Inc.
HA ACTIVUS LPL N 312-G GR
In Commercial Distribution

  • 04056839080870 ()
10955822

  • Air-conduction hearing aid, behind-the-ear
Activus HA ACTIVUS LPL N 312-P DGT Hearing Aid
Ws Audiology Usa, Inc.
HA ACTIVUS LPL N 312-P DGT
In Commercial Distribution

  • 04056839080863 ()
10955823

  • Air-conduction hearing aid, behind-the-ear
Activus HA ACTIVUS LPL N 312-P DKC Hearing Aid
Ws Audiology Usa, Inc.
HA ACTIVUS LPL N 312-P DKC
In Commercial Distribution

  • 04056839080856 ()
10955824

  • Air-conduction hearing aid, behind-the-ear
Activus HA ACTIVUS LPL N 312-P GR Hearing Aid
Ws Audiology Usa, Inc.
HA ACTIVUS LPL N 312-P GR
In Commercial Distribution

  • 04056839080849 ()
10955825

  • Air-conduction hearing aid, behind-the-ear
Activus HA ACTIVUS LPL N 13-S BG Hearing Aid
Ws Audiology Usa, Inc.
HA ACTIVUS LPL N 13-S BG
In Commercial Distribution

  • 04056839080832 ()
10955826

  • Air-conduction hearing aid, behind-the-ear
Activus HA ACTIVUS LPL N 13-S DGT Hearing Aid
Ws Audiology Usa, Inc.
HA ACTIVUS LPL N 13-S DGT
In Commercial Distribution

  • 04056839080825 ()
10955827

  • Air-conduction hearing aid, behind-the-ear
Activus HA ACTIVUS LPL N 13-S DKC Hearing Aid
Ws Audiology Usa, Inc.
HA ACTIVUS LPL N 13-S DKC
In Commercial Distribution

  • 04056839080818 ()
10955828

  • Air-conduction hearing aid, behind-the-ear
Activus HA ACTIVUS LPL N 13-S GR Hearing Aid
Ws Audiology Usa, Inc.
HA ACTIVUS LPL N 13-S GR
In Commercial Distribution

  • 04056839080801 ()
10955829

  • Air-conduction hearing aid, behind-the-ear
Activus HA ACTIVUS LPL N 13-G BG Hearing Aid
Ws Audiology Usa, Inc.
HA ACTIVUS LPL N 13-G BG
In Commercial Distribution

  • 04056839080795 ()
10955830

  • Air-conduction hearing aid, behind-the-ear
Activus HA ACTIVUS LPL N 13-G DKC Hearing Aid
Ws Audiology Usa, Inc.
HA ACTIVUS LPL N 13-G DKC
In Commercial Distribution

  • 04056839080788 ()
10955831

  • Air-conduction hearing aid, behind-the-ear
Activus HA ACTIVUS LPL N 13-G DGT Hearing Aid
Ws Audiology Usa, Inc.
HA ACTIVUS LPL N 13-G DGT
In Commercial Distribution

  • 04056839080771 ()
10955832

  • Air-conduction hearing aid, behind-the-ear
Activus HA ACTIVUS LPL N 13-G GR Hearing Aid
Ws Audiology Usa, Inc.
HA ACTIVUS LPL N 13-G GR
In Commercial Distribution

  • 04056839080764 ()
10955833

  • Air-conduction hearing aid, behind-the-ear
Activus HA ACTIVUS LPL N 13-P BG Hearing Aid
Ws Audiology Usa, Inc.
HA ACTIVUS LPL N 13-P BG
In Commercial Distribution

  • 04056839080757 ()
10955834

  • Air-conduction hearing aid, behind-the-ear
Activus HA ACTIVUS LPL N 13-P DGT Hearing Aid
Ws Audiology Usa, Inc.
HA ACTIVUS LPL N 13-P DGT
In Commercial Distribution

  • 04056839080740 ()
10955835

  • Air-conduction hearing aid, behind-the-ear
Activus HA ACTIVUS LPL N 13-P DKC Hearing Aid
Ws Audiology Usa, Inc.
HA ACTIVUS LPL N 13-P DKC
In Commercial Distribution

  • 04056839080733 ()
10955836

  • Air-conduction hearing aid, behind-the-ear
Activus HA ACTIVUS LPL N 13-P GR Hearing Aid
Ws Audiology Usa, Inc.
HA ACTIVUS LPL N 13-P GR
In Commercial Distribution

  • 04056839080726 ()
10955837

  • Air-conduction hearing aid, behind-the-ear
Activus HA ACTIVUS LPL P100-P BG Hearing Aid
Ws Audiology Usa, Inc.
HA ACTIVUS LPL P100-P BG
In Commercial Distribution

  • 04056839080719 ()
10955838

  • Air-conduction hearing aid, behind-the-ear
Activus HA ACTIVUS LPL P100-P DGT Hearing Aid
Ws Audiology Usa, Inc.
HA ACTIVUS LPL P100-P DGT
In Commercial Distribution

  • 04056839080702 ()
10955839

  • Air-conduction hearing aid, behind-the-ear
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