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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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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