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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Audio Service S_ITE TUNE QUIX G5 R MOC TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE TUNE QUIX G5 R MOC TRD
Not in Commercial Distribution

  • 04056839088395 ()
10960060

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE TUNE QUIX G5 L MOC TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE TUNE QUIX G5 L MOC TBLU
Not in Commercial Distribution

  • 04056839088388 ()
10960059

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE TUNE QUIX G5 R BLK TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE TUNE QUIX G5 R BLK TRD
Not in Commercial Distribution

  • 04056839088371 ()
10960058

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE TUNE QUIX G5 L BLK TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE TUNE QUIX G5 L BLK TBLU
Not in Commercial Distribution

  • 04056839088364 ()
10960057

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE CROS QUIX G5 R MOC TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE CROS QUIX G5 R MOC TRD
Not in Commercial Distribution

  • 04056839088357 ()
10960052

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE CROS QUIX G5 L MOC TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE CROS QUIX G5 L MOC TBLU
Not in Commercial Distribution

  • 04056839088340 ()
10960051

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE CROS QUIX G5 R BLK TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE CROS QUIX G5 R BLK TRD
Not in Commercial Distribution

  • 04056839088333 ()
10960050

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE CROS QUIX G5 L BLK TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE CROS QUIX G5 L BLK TBLU
Not in Commercial Distribution

  • 04056839088326 ()
10960049

  • Air-conduction hearing aid, in-the-ear
Rexton S_ITE CROS INOX 8C R MOC TRD
Ws Audiology Usa, Inc.
S_ITE CROS INOX 8C R MOC TRD
In Commercial Distribution

  • 04056839088319 ()
10960048

  • Air-conduction hearing aid, in-the-ear
Rexton S_ITE CROS INOX 8C L MOC TBLU
Ws Audiology Usa, Inc.
S_ITE CROS INOX 8C L MOC TBLU
In Commercial Distribution

  • 04056839088302 ()
10960047

  • Air-conduction hearing aid, in-the-ear
Rexton S_ITE CROS INOX 8C R BLK TRD
Ws Audiology Usa, Inc.
S_ITE CROS INOX 8C R BLK TRD
In Commercial Distribution

  • 04056839088296 ()
10960046

  • Air-conduction hearing aid, in-the-ear
Rexton S_ITE CROS INOX 8C L BLK TBLU
Ws Audiology Usa, Inc.
S_ITE CROS INOX 8C L BLK TBLU
In Commercial Distribution

  • 04056839088289 ()
10960045

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE TUNE T 2.0 QUIX G5 R BLK TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE TUNE T 2.0 QUIX G5 R BLK TRD
Not in Commercial Distribution

  • 04056839088272 ()
10960043

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE TUNE T 2.0 QUIX G5 L BLK TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE TUNE T 2.0 QUIX G5 L BLK TBLU
Not in Commercial Distribution

  • 04056839088265 ()
10960042

  • Air-conduction hearing aid, in-the-ear
Rexton S_ITE SMART DEMO INOX CIC 8C R TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE SMART DEMO INOX CIC 8C R TRD
In Commercial Distribution

  • 04056839088258 ()
10960041

  • Air-conduction hearing aid, in-the-ear
Rexton S_ITE SMART DEMO INOX CIC 8C L TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE SMART DEMO INOX CIC 8C L TBLU
In Commercial Distribution

  • 04056839088241 ()
10960040

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE QUIX 8 G5 R MOC TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE QUIX 8 G5 R MOC TRD
Not in Commercial Distribution

  • 04056839087930 ()
10958845

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE QUIX 8 G5 L MOC TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE QUIX 8 G5 L MOC TBLU
Not in Commercial Distribution

  • 04056839087923 ()
10958844

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE QUIX 8 G5 R BLK TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE QUIX 8 G5 R BLK TRD
Not in Commercial Distribution

  • 04056839087916 ()
10958843

  • Air-conduction hearing aid, in-the-ear
Rexton S_ITE INOX CIC 40 8C L MOC TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE INOX CIC 40 8C L MOC TBLU
In Commercial Distribution

  • 04056839087909 ()
10958816

  • Air-conduction hearing aid, in-the-ear
Rexton S_ITE INOX CIC 40 8C R MOC TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE INOX CIC 40 8C R MOC TRD
In Commercial Distribution

  • 04056839087893 ()
10958817

  • Air-conduction hearing aid, in-the-ear
Rexton S_ITE INOX CIC 40 8C R BLK TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE INOX CIC 40 8C R BLK TRD
In Commercial Distribution

  • 04056839087886 ()
10958815

  • Air-conduction hearing aid, in-the-ear
Rexton S_ITE INOX CIC 40 8C L BLK TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE INOX CIC 40 8C L BLK TBLU
In Commercial Distribution

  • 04056839087879 ()
10958814

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE QUIX 8 G5 L BLK TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE QUIX 8 G5 L BLK TBLU
Not in Commercial Distribution

  • 04056839087862 ()
10958842

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE QUIX 12 G5 R MOC TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE QUIX 12 G5 R MOC TRD
Not in Commercial Distribution

  • 04056839087725 ()
10958841

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE QUIX 12 G5 L MOC TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE QUIX 12 G5 L MOC TBLU
Not in Commercial Distribution

  • 04056839087718 ()
10958840

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE QUIX 12 G5 R BLK TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE QUIX 12 G5 R BLK TRD
Not in Commercial Distribution

  • 04056839087701 ()
10958839

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE QUIX 12 G5 L BLK TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE QUIX 12 G5 L BLK TBLU
Not in Commercial Distribution

  • 04056839087695 ()
10958838

  • Air-conduction hearing aid, in-the-ear
Rexton S_ITE INOX CIC 60 8C R MOC TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE INOX CIC 60 8C R MOC TRD
In Commercial Distribution

  • 04056839087688 ()
10958813

  • Air-conduction hearing aid, in-the-ear
Rexton S_ITE INOX CIC 60 8C L MOC TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE INOX CIC 60 8C L MOC TBLU
In Commercial Distribution

  • 04056839087671 ()
10958812

  • Air-conduction hearing aid, in-the-ear
Rexton S_ITE INOX CIC 60 8C R BLK TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE INOX CIC 60 8C R BLK TRD
In Commercial Distribution

  • 04056839087664 ()
10958811

  • Air-conduction hearing aid, in-the-ear
Rexton S_ITE INOX CIC 60 8C L BLK TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE INOX CIC 60 8C L BLK TBLU
In Commercial Distribution

  • 04056839087657 ()
10958810

  • Air-conduction hearing aid, in-the-ear
Rexton S_ITE ADORE IX R MOC TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE ADORE IX R MOC TRD
In Commercial Distribution

  • 04056839087640 ()
10960080

  • Air-conduction hearing aid, in-the-ear
Rexton S_ITE ADORE IX L MOC TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE ADORE IX L MOC TBLU
In Commercial Distribution

  • 04056839087633 ()
10960079

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE QUIX 16 G5 R MOC TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE QUIX 16 G5 R MOC TRD
Not in Commercial Distribution

  • 04056839087602 ()
10958837

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE QUIX 16 G5 L MOC TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE QUIX 16 G5 L MOC TBLU
Not in Commercial Distribution

  • 04056839087596 ()
10958836

  • Air-conduction hearing aid, in-the-ear
Rexton S_ITE INOX CIC 80 8C R MOC TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE INOX CIC 80 8C R MOC TRD
In Commercial Distribution

  • 04056839087589 ()
10958809

  • Air-conduction hearing aid, in-the-ear
Rexton S_ITE INOX CIC 80 8C L MOC TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE INOX CIC 80 8C L MOC TBLU
In Commercial Distribution

  • 04056839087572 ()
10958808

  • Air-conduction hearing aid, in-the-ear
Rexton S_ITE ADORE IX R BLK TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE ADORE IX R BLK TRD
In Commercial Distribution

  • 04056839087565 ()
10960078

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE QUIX 16 G5 R BLK TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE QUIX 16 G5 R BLK TRD
Not in Commercial Distribution

  • 04056839087541 ()
10958835

  • Air-conduction hearing aid, in-the-ear
Rexton S_ITE INOX CIC 80 8C R BLK TRD Hearing Aid
Ws Audiology Usa, Inc.
S_ITE INOX CIC 80 8C R BLK TRD
In Commercial Distribution

  • 04056839087534 ()
10958807

  • Air-conduction hearing aid, in-the-ear
Rexton S_ITE ADORE IX L BLK TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE ADORE IX L BLK TBLU
In Commercial Distribution

  • 04056839087527 ()
10960077

  • Air-conduction hearing aid, in-the-ear
Audio Service S_ITE QUIX 16 G5 L BLK TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE QUIX 16 G5 L BLK TBLU
Not in Commercial Distribution

  • 04056839087503 ()
10958834

  • Air-conduction hearing aid, in-the-ear
Rexton S_ITE INOX CIC 80 8C L BLK TBLU Hearing Aid
Ws Audiology Usa, Inc.
S_ITE INOX CIC 80 8C L BLK TBLU
In Commercial Distribution

  • 04056839087497 ()
10958806

  • Air-conduction hearing aid, in-the-ear
Rexton C_ITE STERLING 80 8C HS/ITC Hearing Aid
Ws Audiology Usa, Inc.
C_ITE STERLING 80 8C HS/ITC
In Commercial Distribution

  • 04056839087466 ()
10961427

  • Air-conduction hearing aid, in-the-ear
Rexton C_ITE STERLING 60 8C HS/ITC Hearing Aid
Ws Audiology Usa, Inc.
C_ITE STERLING 60 8C HS/ITC
In Commercial Distribution

  • 04056839087459 ()
10961428

  • Air-conduction hearing aid, in-the-ear
Rexton C_ITE STERLING 40 8C HS/ITC Hearing Aid
Ws Audiology Usa, Inc.
C_ITE STERLING 40 8C HS/ITC
In Commercial Distribution

  • 04056839087442 ()
10961429

  • Air-conduction hearing aid, in-the-ear
S_ITE M-CORE IX-CIC 80DEMO TRD
Ws Audiology Usa, Inc.
M-Core iX-CIC SDemo
In Commercial Distribution

  • 04056839087428 ()
10996094

  • Air-conduction hearing aid, in-the-ear
S_ITE M-CORE IX-CIC 80DEMO TBLU
Ws Audiology Usa, Inc.
M-Core iX-CIC SDemo
In Commercial Distribution

  • 04056839087411 ()
10996093

  • Air-conduction hearing aid, in-the-ear
M-Core R-Li 20 Grey
Ws Audiology Usa, Inc.
M-Core R-Li 20
In Commercial Distribution

  • 04056839087374 ()
10986206

  • Air-conduction hearing aid, receiver-in-canal
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