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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APP,RS SMART,3.3.2,IOS
Gn Hearing A/S
20401700
In Commercial Distribution

  • 05708296070817 ()


  • Hearing aid/implant system remote control
APP,BT HEARP,3.4,IOS
Gn Hearing A/S
20416700
In Commercial Distribution

  • 05708296074228 ()


  • Hearing aid/implant system remote control
APP,RS SMART,3.4,IOS
Gn Hearing A/S
20416500
In Commercial Distribution

  • 05708296074204 ()


  • Hearing aid/implant system remote control
IOS Hearing Aid Programming App
INTRICON CORPORATION
Lexie
In Commercial Distribution

  • 00858177007458 ()
Lexie IOS App

  • Audiometric/hearing device software
APP,JABRA,ENHANCE,1.0.0,IOS
Gn Hearing A/S
22153200
In Commercial Distribution

  • 05708296229185 ()


  • Hearing aid/implant system remote control
APP,JABRA,ENHANCE PRO,IOS
Gn Hearing A/S
21820200
In Commercial Distribution

  • 05708296214662 ()


  • Hearing aid/implant system remote control
APP,MY LIVELY 1.4,IOS
Gn Hearing A/S
21123000
In Commercial Distribution

  • 05708296169702 ()


  • Hearing aid/implant system remote control
APP,KS DISCOVER,1.4,IOS
Gn Hearing A/S
20665200
In Commercial Distribution

  • 05708296164295 ()


  • Hearing aid/implant system remote control
SW M01A02 CARELINK SMARTSYNC IOS
MEDTRONIC, INC.
M01A02
In Commercial Distribution

  • 00643169833739 ()


  • Implantable cardiac device management application software
Tinnitus app iOS version 1.0
Widex A/S
Tinnitus app
In Commercial Distribution

  • 05706069674712 ()
5 300 0006 001

  • Tinnitus masking application software
BEYOND app iOS version 1.1
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069673562 ()
5 300 0004 001

  • Hearing aid/implant system remote control
APP WIDEX REMOTE CARE IOS
Widex A/S
Remote Care 1.3.4
In Commercial Distribution

  • 05706069779707 ()
21035227

  • Hearing aid/implant system remote control
BMS CT360 iOS Clinician App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 iOS Clinician App
Not in Commercial Distribution

  • 00851203006258 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
BMS CT360 iOS Patient App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 iOS Patient App
Not in Commercial Distribution

  • 00851203006241 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
Bernafon EasyControl Connect 3.3.0 iOS
Sbo Hearing A/S
228215
In Commercial Distribution

  • 05714464012992 ()


  • Hearing aid/implant system remote control
Sonic SoundLink Connect 3.3.0 iOS
Sbo Hearing A/S
228213
In Commercial Distribution

  • 05714464012978 ()


  • Hearing aid/implant system remote control
Philips HearLink Connect 3.3.0 iOS
Sbo Hearing A/S
228211
In Commercial Distribution

  • 05714464012954 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK CONNECT 3.1.0 IOS
Sbo Hearing A/S
215186
In Commercial Distribution

  • 05714464004621 ()


  • Hearing aid/implant system remote control
SONIC SOUNDLINK CONNECT 3.1.0 IOS
Sbo Hearing A/S
215184
In Commercial Distribution

  • 05714464004607 ()


  • Hearing aid/implant system remote control
BERNAFON EASYCONTROL CONNECT 3.1.0 IOS
Sbo Hearing A/S
215182
In Commercial Distribution

  • 05714464004584 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2 1.5.0 IOS
Sbo Hearing A/S
274917
In Commercial Distribution

  • 05714464146086 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2 1.4.0 IOS
Sbo Hearing A/S
270492
In Commercial Distribution

  • 05714464139460 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2 1.3.0 IOS
Sbo Hearing A/S
269358
In Commercial Distribution

  • 05714464133987 ()


  • Hearing aid/implant system remote control
SONIC SOUNDLINK 3 1.2.0 IOS
Sbo Hearing A/S
265708
In Commercial Distribution

  • 05714464127177 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2 1.2.0 IOS
Sbo Hearing A/S
265706
In Commercial Distribution

  • 05714464127153 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2 1.1.0 IOS
Sbo Hearing A/S
264788
In Commercial Distribution

  • 05714464125227 ()


  • Hearing aid/implant system remote control
IOS VMAX SERIES OPTION-ICU CART
VYAIRE MEDICAL, INC.
776268-103
In Commercial Distribution

  • 10190752164154 ()
776268-103

  • Neonatal/adult intensive-care ventilator
VELYS Hip Navigation for iOS
DEPUY ORTHOPAEDICS, INC.
451580052
In Commercial Distribution

  • 10603295532040 ()
451580052

  • Orthopaedic stereotactic surgery system
Lingo Biosensor iOS App US
ABBOTT DIABETES CARE INC
78783-01
In Commercial Distribution

  • 00357599849009 ()
78783-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Vscan Air R2 for iOS
GE Vingmed Ultrasound AS
Air R2 for iOS
In Commercial Distribution

  • 00195278640550 ()


  • Ultrasound imaging system application software
Kosmos OTS iOS Software Package
ECHONOUS, INC.
P007639
In Commercial Distribution

  • 09353278000717 ()


  • Ultrasound imaging system application software
Vscan Air R3 for iOS
GE Vingmed Ultrasound AS
Air R3 for iOS
In Commercial Distribution

  • 00195278884749 ()


  • Ultrasound imaging system application software
DreamMapper Mobile Application iOS EMEA
Respironics, Inc.
2.8
In Commercial Distribution

  • 00606959047532 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper Mobile Application iOS EMEA
Respironics, Inc.
2.7
In Commercial Distribution

  • 00606959046818 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper Mobile Application iOS EMEA
Respironics, Inc.
2.6
In Commercial Distribution

  • 00606959044401 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper Mobile Application iOS EMEA
Respironics, Inc.
2.5
In Commercial Distribution

  • 00606959042018 ()
1128264

  • Self-care monitoring/reporting software
HFX 2.0 Patient Application (iOS)
NEVRO CORP.
PTA10043
In Commercial Distribution

  • 00813426021135 ()


  • Implantable electrical stimulation device management software
HFX iQ Patient Application (iOS)
NEVRO CORP.
PTA10043
In Commercial Distribution

  • 00813426020817 ()
PTA10043

  • Implantable electrical stimulation device management software
SFTWR MMT-6122 FOTA IOS V1.3.4
MEDTRONIC MINIMED, INC.
MMT-6122
In Commercial Distribution

  • 00763000532178 ()


  • Patient health record information system application software
MY TSF HOMECARE APP iOS
Smith & Nephew, Inc.
71075402
In Commercial Distribution

  • 00885556746387 ()
71075402

  • Wireless patient monitor/sensor reporting software, layperson-use
TG Ab - CENTAUR - CTL - 2x3x2mL
Siemens Healthcare Diagnostics Inc.
10630917
In Commercial Distribution

  • 00630414587905 ()
10630917

  • Thyroglobulin antibody IVD, control
TG Ab CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373706
In Commercial Distribution

  • 00630414971384 ()
LTGCVM

  • Thyroglobulin antibody IVD, control
Mod. S13K/TG, Boston Univ
HU-FRIEDY MFG. CO., LLC
PP7065
In Commercial Distribution

  • 10889950139940 ()


  • Periodontal file/rasp, manual
S13K/TG Jovanovic 6MM. Chisel
HU-FRIEDY MFG. CO., LLC
PJO/3
In Commercial Distribution

  • 10889950018948 ()
PJO/3

  • Periodontal file/rasp, manual
S13K/TG Jovanovic 5MM Chisel
HU-FRIEDY MFG. CO., LLC
PJO/2
In Commercial Distribution

  • 10889950018917 ()
PJO/2

  • Periodontal file/rasp, manual
S13K/TG Jovanovic 4MM Chisel
HU-FRIEDY MFG. CO., LLC
PJO/1
In Commercial Distribution

  • 10889950018894 ()
PJO/1

  • Periodontal file/rasp, manual
TG Chisel, Modified, Smooth HDL
HU-FRIEDY MFG. CO., LLC
CTG-OCH
In Commercial Distribution

  • 10889950045180 ()
CTG-OCH

  • Periodontal file/rasp, manual
#13/TG DE Curette/Chisel
HU-FRIEDY MFG. CO., LLC
S13K/TGS6
In Commercial Distribution

  • 10889950022570 ()
S13K/TGS6

  • Periodontal file/rasp, manual
TG PRO TACO XS-S STRAP
MEDI MANUFACTURING, INC.
200963
Not in Commercial Distribution

  • 00636257156179 ()


  • Ankle/foot orthosis
TG PRO TACO XXS STRAP
MEDI MANUFACTURING, INC.
200903
Not in Commercial Distribution

  • 00636257156162 ()


  • Ankle/foot orthosis
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