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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Baha® Fitting Software
Cochlear Bone Anchored Solutions AB
P803254
In Commercial Distribution

  • 09321502036023 ()
P803254

  • Hearing aid wireless-fitting computer-aided set
Baha Fitting Software 4.0
Cochlear Bone Anchored Solutions AB
94223
In Commercial Distribution

  • 09321502026383 ()
94223

  • Hearing aid wireless-fitting computer-aided set
N/A
Cochlear Bone Anchored Solutions AB
P1457850
In Commercial Distribution

  • 09321502044097 ()
P1457850

  • Hearing aid wireless-fitting computer-aided set
N/A
Cochlear Bone Anchored Solutions AB
P878156
In Commercial Distribution

  • 09321502038966 ()
P878156

  • Hearing aid wireless-fitting computer-aided set
N/A
Cochlear Bone Anchored Solutions AB
P878155
Not in Commercial Distribution

  • 09321502038959 ()
P878155

  • Hearing aid wireless-fitting computer-aided set
Baha® Fitting Software
Cochlear Bone Anchored Solutions AB
95430
In Commercial Distribution

  • 09321502032834 ()
95430

  • Hearing aid wireless-fitting computer-aided set
INTENT 1 FW 1.0.0
Sbo Hearing A/S
268429
In Commercial Distribution

  • 05714464133130 ()


  • Hearing aid wireless-fitting computer-aided set
ALIGO AX 5 FW 1.1.0
Sbo Hearing A/S
262924
In Commercial Distribution

  • 05714464123025 ()


  • Hearing aid wireless-fitting computer-aided set
ALIGO XT 7 FW 1.1.0
Sbo Hearing A/S
262923
In Commercial Distribution

  • 05714464123018 ()


  • Hearing aid wireless-fitting computer-aided set
ALIGO XT 9 FW 1.1.0
Sbo Hearing A/S
262922
In Commercial Distribution

  • 05714464123001 ()


  • Hearing aid wireless-fitting computer-aided set
HEARLINK 5040 FW 1.1.0
Sbo Hearing A/S
262921
In Commercial Distribution

  • 05714464122998 ()


  • Hearing aid wireless-fitting computer-aided set
HEARLINK 7040 FW 1.1.0
Sbo Hearing A/S
262920
In Commercial Distribution

  • 05714464122981 ()


  • Hearing aid wireless-fitting computer-aided set
HEARLINK 9040 FW 1.1.0
Sbo Hearing A/S
262919
In Commercial Distribution

  • 05714464122974 ()


  • Hearing aid wireless-fitting computer-aided set
RADIANT SE 60 FW 1.1.0
Sbo Hearing A/S
262918
In Commercial Distribution

  • 05714464122967 ()


  • Hearing aid wireless-fitting computer-aided set
RADIANT SE 80 FW 1.1.0
Sbo Hearing A/S
262917
In Commercial Distribution

  • 05714464122950 ()


  • Hearing aid wireless-fitting computer-aided set
RADIANT SE 100 FW 1.1.0
Sbo Hearing A/S
262916
In Commercial Distribution

  • 05714464122943 ()


  • Hearing aid wireless-fitting computer-aided set
ALPHA XT 5 FW 1.1.0
Sbo Hearing A/S
262915
In Commercial Distribution

  • 05714464122936 ()


  • Hearing aid wireless-fitting computer-aided set
ALPHA XT 7 FW 1.1.0
Sbo Hearing A/S
262914
In Commercial Distribution

  • 05714464122929 ()


  • Hearing aid wireless-fitting computer-aided set
ALPHA XT 9 FW 1.1.0
Sbo Hearing A/S
262913
In Commercial Distribution

  • 05714464122912 ()


  • Hearing aid wireless-fitting computer-aided set
E300 FW 1.1.0
Sbo Hearing A/S
262901
In Commercial Distribution

  • 05714464122790 ()


  • Hearing aid wireless-fitting computer-aided set
E400 FW 1.1.0
Sbo Hearing A/S
262900
In Commercial Distribution

  • 05714464122783 ()


  • Hearing aid wireless-fitting computer-aided set
E500 FW 1.1.0
Sbo Hearing A/S
262899
In Commercial Distribution

  • 05714464122776 ()


  • Hearing aid wireless-fitting computer-aided set
REAL 3 FW 1.1.0
Sbo Hearing A/S
262886
In Commercial Distribution

  • 05714464122646 ()


  • Hearing aid wireless-fitting computer-aided set
REAL 2 FW 1.1.0
Sbo Hearing A/S
262885
In Commercial Distribution

  • 05714464122639 ()


  • Hearing aid wireless-fitting computer-aided set
REAL 1 FW 1.1.0
Sbo Hearing A/S
262884
In Commercial Distribution

  • 05714464122622 ()


  • Hearing aid wireless-fitting computer-aided set
AOXT5 FW 1.1.1
Sbo Hearing A/S
280492
In Commercial Distribution

  • 05714464159390 ()


  • Hearing aid wireless-fitting computer-aided set
AOXT7 FW 1.1.1
Sbo Hearing A/S
280491
In Commercial Distribution

  • 05714464159383 ()


  • Hearing aid wireless-fitting computer-aided set
AOXT9 FW 1.1.1
Sbo Hearing A/S
280490
In Commercial Distribution

  • 05714464159376 ()


  • Hearing aid wireless-fitting computer-aided set
V GO T13 FW 1.4.5
Sbo Hearing A/S
277531
In Commercial Distribution

  • 05714464150526 ()


  • Hearing aid wireless-fitting computer-aided set
SONITON Z1.10 FW 1.0.0
Sbo Hearing A/S
277533
In Commercial Distribution

  • 05714464150519 ()


  • Hearing aid wireless-fitting computer-aided set
SONITON Z1.20 FW 1.0.0
Sbo Hearing A/S
277532
In Commercial Distribution

  • 05714464150502 ()


  • Hearing aid wireless-fitting computer-aided set
PERSONAL 6.4 FW 1.4.5
Sbo Hearing A/S
277529
In Commercial Distribution

  • 05714464150496 ()


  • Hearing aid wireless-fitting computer-aided set
PERSONAL 5.4 FW 1.4.5
Sbo Hearing A/S
277528
In Commercial Distribution

  • 05714464150489 ()


  • Hearing aid wireless-fitting computer-aided set
V GO T23 FW 1.4.5
Sbo Hearing A/S
277530
In Commercial Distribution

  • 05714464150472 ()


  • Hearing aid wireless-fitting computer-aided set
HEARLINK 1530 FW 1.4.5
Sbo Hearing A/S
277081
In Commercial Distribution

  • 05714464150250 ()


  • Hearing aid wireless-fitting computer-aided set
HEARLINK 1730 FW 1.4.5
Sbo Hearing A/S
277080
In Commercial Distribution

  • 05714464150243 ()


  • Hearing aid wireless-fitting computer-aided set
ENTRA B 10 FW 1.0.0
Sbo Hearing A/S
276162
In Commercial Distribution

  • 05714464150236 ()


  • Hearing aid wireless-fitting computer-aided set
ENTRA B 20 FW 1.0.0
Sbo Hearing A/S
276161
In Commercial Distribution

  • 05714464150229 ()


  • Hearing aid wireless-fitting computer-aided set
Z1.10 FW 1.0.0
Sbo Hearing A/S
277086
In Commercial Distribution

  • 05714464150212 ()


  • Hearing aid wireless-fitting computer-aided set
Z1.20 FW 1.0.0
Sbo Hearing A/S
277085
In Commercial Distribution

  • 05714464150205 ()


  • Hearing aid wireless-fitting computer-aided set
F60 FW 1.4.5
Sbo Hearing A/S
277084
In Commercial Distribution

  • 05714464150182 ()


  • Hearing aid wireless-fitting computer-aided set
F80 FW 1.4.5
Sbo Hearing A/S
277083
In Commercial Distribution

  • 05714464150175 ()


  • Hearing aid wireless-fitting computer-aided set
JET PX 2 FW 1.0.0
Sbo Hearing A/S
276160
In Commercial Distribution

  • 05714464150168 ()


  • Hearing aid wireless-fitting computer-aided set
JET PX 1 FW 1.0.0
Sbo Hearing A/S
276159
In Commercial Distribution

  • 05714464150151 ()


  • Hearing aid wireless-fitting computer-aided set
B200 FW 1.2.0
Sbo Hearing A/S
274990
In Commercial Distribution

  • 05714464146918 ()


  • Hearing aid wireless-fitting computer-aided set
B300 FW 1.2.0
Sbo Hearing A/S
274989
In Commercial Distribution

  • 05714464146901 ()


  • Hearing aid wireless-fitting computer-aided set
B400 FW 1.2.0
Sbo Hearing A/S
274988
In Commercial Distribution

  • 05714464146895 ()


  • Hearing aid wireless-fitting computer-aided set
B500 FW 1.2.0
Sbo Hearing A/S
274987
In Commercial Distribution

  • 05714464146888 ()


  • Hearing aid wireless-fitting computer-aided set
B DEMOFLEX FW 1.2.0
Sbo Hearing A/S
274986
In Commercial Distribution

  • 05714464146871 ()


  • Hearing aid wireless-fitting computer-aided set
ENCANTA 400 FW 1.2.0
Sbo Hearing A/S
274967
In Commercial Distribution

  • 05714464146758 ()


  • Hearing aid wireless-fitting computer-aided set
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