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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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 Connect 3.4.0 iOS
Sbo Hearing A/S
234032
In Commercial Distribution

  • 05714464034659 ()


  • Hearing aid/implant system remote control
Sonic SoundLink Connect 3.4.0 iOS
Sbo Hearing A/S
234030
In Commercial Distribution

  • 05714464034635 ()


  • Hearing aid/implant system remote control
Bernafon EasyControl Connect 3.4.0 iOS
Sbo Hearing A/S
234028
In Commercial Distribution

  • 05714464034611 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK CONNECT 3.5.0 IOS
Sbo Hearing A/S
246112
In Commercial Distribution

  • 05714464059782 ()


  • Hearing aid/implant system remote control
SONIC SOUNDLINK CONNECT 3.5.0 IOS
Sbo Hearing A/S
246110
In Commercial Distribution

  • 05714464059768 ()


  • Hearing aid/implant system remote control
BERNAFON EASYCONTROL CONNECT 3.5.0 IOS
Sbo Hearing A/S
246108
In Commercial Distribution

  • 05714464059744 ()


  • Hearing aid/implant system remote control
Philips HearLink 2 1.0.0 iOS
Sbo Hearing A/S
242488
In Commercial Distribution

  • 05714464058990 ()


  • Hearing aid/implant system remote control
Vision testing application - iOS version
Brightinsight, Inc.
1
In Commercial Distribution

  • 00860003376157 ()


  • Vision self-testing software
DreamMapper Mobile Application iOS EMEA
Respironics, Inc.
2.6
In Commercial Distribution

  • 00606959044401 ()
1128264

  • Self-care monitoring/reporting software
Kosmos OTS iOS Software Package
ECHONOUS, INC.
P007639
In Commercial Distribution

  • 09353278000717 ()


  • 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.
2.5
In Commercial Distribution

  • 00606959042018 ()
1128264

  • Self-care monitoring/reporting software
Vscan Air R3 for iOS
GE Vingmed Ultrasound AS
Air R3 for iOS
In Commercial Distribution

  • 00195278884749 ()


  • Ultrasound imaging system application software
Vscan Air R2 for iOS
GE Vingmed Ultrasound AS
Air R2 for iOS
In Commercial Distribution

  • 00195278640550 ()


  • Ultrasound imaging system application software
VELYS Hip Navigation for iOS
DEPUY ORTHOPAEDICS, INC.
451580052
In Commercial Distribution

  • 10603295532040 ()
451580052

  • Orthopaedic stereotactic surgery system
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
TG Chisel, Modified, Smooth HDL
HU-FRIEDY MFG. CO., LLC
CTG-OCH
In Commercial Distribution

  • 10889950045180 ()
CTG-OCH

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

  • 10889950022570 ()
S13K/TGS6

  • Periodontal file/rasp, manual
TG Ab CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373706
In Commercial Distribution

  • 00630414971384 ()
LTGCVM

  • Thyroglobulin antibody IVD, control
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
TG PRO TACO L-XL STRAP
MEDI MANUFACTURING, INC.
200146
Not in Commercial Distribution

  • 00636257156117 ()


  • Ankle/foot orthosis
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