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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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Beltone - 05708296077038

SW,FSW,BT,SOLUS PRO 1.11
Gn Hearing A/S
20450300
In Commercial Distribution

  • 05708296077038 ()


  • Audiometric/hearing device software

GN ReSound - 05708296077021

SW,FSW,RS AVENTA 3.11
Gn Hearing A/S
20450200
In Commercial Distribution

  • 05708296077021 ()


  • Audiometric/hearing device software

GN ReSound - 05708296077014

SW,FSW,AUDIGY 1.0
Gn Hearing A/S
20449000
In Commercial Distribution

  • 05708296077014 ()


  • Audiometric/hearing device software

GN ReSound - 05708296077007

USB,FSW,AUDIGY 1.0
Gn Hearing A/S
20448900
In Commercial Distribution

  • 05708296077007 ()


  • Audiometric/hearing device software

EarliPoint - 00860009993709

The EarliPoint System is an eye tracking device used as a tool to aid clinicians in the diagnosis and assessment of ASD patients.
Earlitec Diagnostics, Inc.
EPT001
In Commercial Distribution

  • 00860009993709 ()


  • Neurodevelopmental disorder interpretive software

OculoMotor Technologies - 00860012940608

Virtual Eye Rotation Vision Exercises for Convergence Insufficiency Therapy
Oculomotor Technologies Inc.
VERVE
In Commercial Distribution

  • 00860012940608 ()


  • Virtual-display routine exercise software

Veris Health - 00860009591004

Medical Device Data Systems (MDDS)
Veris Health Inc.
Veris Health Platform
In Commercial Distribution

  • 00860009591004 ()


  • Self-care monitoring/reporting software

GN ReSound - 05708296087907

SW,FSW,RS,AVENTA 3.12
Gn Hearing A/S
20594700
In Commercial Distribution

  • 05708296087907 ()


  • Audiometric/hearing device software

Beltone - 05708296085675

DVD,FSW,BT SOLUS MAX 1.0#1,US
Gn Hearing A/S
20552310
In Commercial Distribution

  • 05708296085675 ()


  • Audiometric/hearing device software

Beltone - 05708296085651

DVD,FSW,BT SOLUS MAX 1.0#1
Gn Hearing A/S
20551610
In Commercial Distribution

  • 05708296085651 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085620

DVD,FSW,RS SMART FIT 1.0#1,US
Gn Hearing A/S
20551010
In Commercial Distribution

  • 05708296085620 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085606

DVD,FSW,RS SMART FIT 1.0#1
Gn Hearing A/S
20550410
In Commercial Distribution

  • 05708296085606 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085590

SW,FSW,RS SMART FIT 1.0#1
Gn Hearing A/S
20550300
In Commercial Distribution

  • 05708296085590 ()


  • Audiometric/hearing device software

Beltone - 05708296085569

DVD,FSW,BT SOLUS MAX 1.1
Gn Hearing A/S
20523611
In Commercial Distribution

  • 05708296085569 ()


  • Audiometric/hearing device software

Beltone - 05708296085552

SW,FSW,BT SOLUS MAX 1.1
Gn Hearing A/S
20523900
In Commercial Distribution

  • 05708296085552 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085507

USB,FSW,RS SMART FIT 1.1,US
Gn Hearing A/S
20521611
In Commercial Distribution

  • 05708296085507 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085491

DVD,FSW,RS SMART FIT 1.1,US
Gn Hearing A/S
20521111
In Commercial Distribution

  • 05708296085491 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085422

SW,FSW,RS SMART FIT 1.3
Gn Hearing A/S
20660100
In Commercial Distribution

  • 05708296085422 ()


  • Audiometric/hearing device software

Beltone - 05708296087914

SW,FSW,BT,SOLUS PRO 1.12
Gn Hearing A/S
20594800
In Commercial Distribution

  • 05708296087914 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085989

DVD,FSW,SMART FIT 1.1,COSTCO
Gn Hearing A/S
20577911
In Commercial Distribution

  • 05708296085989 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085972

SW,FSW,AVENTA 3.12,COSTCO
Gn Hearing A/S
20579000
In Commercial Distribution

  • 05708296085972 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085965

SW,FSW,SMART FIT 1.1,COSTCO
Gn Hearing A/S
20578900
In Commercial Distribution

  • 05708296085965 ()


  • Audiometric/hearing device software

Beltone - 05708296085682

USB,FSW,BT SOLUS MAX 1.0#1,US
Gn Hearing A/S
20552610
In Commercial Distribution

  • 05708296085682 ()


  • Audiometric/hearing device software

Beltone - 05708296085668

USB,FSW,BT SOLUS MAX 1.0#1
Gn Hearing A/S
20552010
In Commercial Distribution

  • 05708296085668 ()


  • Audiometric/hearing device software

Beltone - 05708296085644

SW,FSW,BT SOLUS MAX 1.0#1
Gn Hearing A/S
20551700
In Commercial Distribution

  • 05708296085644 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085637

USB,FSW,RS SMART FIT 1.0#1,US
Gn Hearing A/S
20551310
In Commercial Distribution

  • 05708296085637 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085613

USB,FSW,RS SMART FIT 1.0#1
Gn Hearing A/S
20550710
In Commercial Distribution

  • 05708296085613 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085538

DVD,FSW,RS SMART FIT 1.1
Gn Hearing A/S
20523011
In Commercial Distribution

  • 05708296085538 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085514

DVD,FSW,RS SMART FIT 1.1,VA
Gn Hearing A/S
20522111
In Commercial Distribution

  • 05708296085514 ()


  • Audiometric/hearing device software

GN ReSound - 05708296085484

SW,FSW,RS SMART FIT 1.1
Gn Hearing A/S
20521400
In Commercial Distribution

  • 05708296085484 ()


  • Audiometric/hearing device software

Synchrony Dysphagia Solutions by ACP - 00858703006337

Bioelectrical signal analysis software; Biomechanical function analysis, interactive rehabilitation system
ACCELERATED CARE PLUS CORP
300800A
In Commercial Distribution

  • 00858703006337 ()


  • Bioelectrical signal analysis software

hearX - 00858177007465

Android Hearing Aid Programming App
INTRICON CORPORATION
Lexie
In Commercial Distribution

  • 00858177007465 ()
Lexie Android App

  • Audiometric/hearing device software

hearX - 00858177007458

IOS Hearing Aid Programming App
INTRICON CORPORATION
Lexie
In Commercial Distribution

  • 00858177007458 ()
Lexie IOS App

  • Audiometric/hearing device software

Hearing Help Express - 00858177007335

Android App
INTRICON CORPORATION
HHE Hearing
In Commercial Distribution

  • 00858177007335 ()
23354

  • Audiometric/hearing device software

hiHealth Innovations - 00858177007144

Android App
INTRICON CORPORATION
hiHearing
In Commercial Distribution

  • 00858177007144 ()
22958

  • Audiometric/hearing device software

Hearing Help Express - 00858177007113

iOS App
INTRICON CORPORATION
HHE Hearing
In Commercial Distribution

  • 00858177007113 ()
23150

  • Audiometric/hearing device software

hi Health Innovations - 00858177007069

IOS Remote Control App
INTRICON CORPORATION
Remote
In Commercial Distribution

  • 00858177007069 ()
22957

  • Audiometric/hearing device software

GN Hearing - 05708296265565

USB,FSW XB1.15,US,UP1
Gn Hearing A/S
22284700
In Commercial Distribution

  • 05708296265565 ()


  • Audiometric/hearing device software

GN Hearing - 05708296265558

USB,FSW XB1.15,UP1
Gn Hearing A/S
22284800
In Commercial Distribution

  • 05708296265558 ()


  • Audiometric/hearing device software

Beltone - 05708296265541

USB,FSW SM1.15,SP1,US,UP1
Gn Hearing A/S
22284100
In Commercial Distribution

  • 05708296265541 ()


  • Audiometric/hearing device software

Beltone - 05708296265534

USB,FSW SM1.15,SP1,UP1
Gn Hearing A/S
22284200
In Commercial Distribution

  • 05708296265534 ()


  • Audiometric/hearing device software

GN ReSound - 05708296265527

USB,FSW SF1.15,AV3,US,UP1
Gn Hearing A/S
22283900
In Commercial Distribution

  • 05708296265527 ()


  • Audiometric/hearing device software

GN ReSound - 05708296265510

USB,FSW SF1.15,AV3,UP1
Gn Hearing A/S
22283800
In Commercial Distribution

  • 05708296265510 ()


  • Audiometric/hearing device software

GN Hearing - 05708296265497

USB,FSW DL1.15,AV3,UP1
Gn Hearing A/S
22285500
In Commercial Distribution

  • 05708296265497 ()


  • Audiometric/hearing device software

GN Hearing - 05708296265480

USB,FSW AG2.15,AG1,US,UP1
Gn Hearing A/S
22284500
In Commercial Distribution

  • 05708296265480 ()


  • Audiometric/hearing device software

GN Hearing - 05708296265473

USB,FSW AG2.15,AG1,UP1
Gn Hearing A/S
22284400
In Commercial Distribution

  • 05708296265473 ()


  • Audiometric/hearing device software

GN Hearing - 05708296265466

SW,FSW XE BEMORE 1.15,UP1
Gn Hearing A/S
22284600
In Commercial Distribution

  • 05708296265466 ()


  • Audiometric/hearing device software

Beltone - 05708296265459

SW,FSW SOLUS MAX 1.15,UP1
Gn Hearing A/S
22284000
In Commercial Distribution

  • 05708296265459 ()


  • Audiometric/hearing device software

GN ReSound - 05708296265442

SW,FSW SMART FIT LTD 1.15,UP1
Gn Hearing A/S
22285200
In Commercial Distribution

  • 05708296265442 ()


  • Audiometric/hearing device software

GN ReSound - 05708296265435

SW,FSW SMART FIT 1.15,UP1
Gn Hearing A/S
22283600
In Commercial Distribution

  • 05708296265435 ()


  • Audiometric/hearing device software
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