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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myPhonak 4.0 app
Sonova AG
088-0013-08
In Commercial Distribution

  • 07613389402933 ()
088-0013-08

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-45
In Commercial Distribution

  • 07613389402926 ()
088-0013-45

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-15
In Commercial Distribution

  • 07613389402919 ()
088-0013-15

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013
In Commercial Distribution

  • 07613389402810 ()
088-0013

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-18
In Commercial Distribution

  • 07613389399301 ()
088-0013-18

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-70
In Commercial Distribution

  • 07613389399295 ()
088-0013-70

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-24
In Commercial Distribution

  • 07613389399288 ()
088-0013-24

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-21
In Commercial Distribution

  • 07613389399271 ()
088-0013-21

  • Audiometric/hearing device software
SCS Programming App
NALU MEDICAL, INC.
53001
In Commercial Distribution

  • 00812537030463 ()
53001

  • Implantable electrical stimulation device management software
Holter Mobile App
Lifesignals, Inc.
UA2251-R
In Commercial Distribution

  • B353UA2251R1 ()


  • Medical equipment clinical data interfacing software
Dialogue AAC App
PRENTKE ROMICH COMPANY
Dialogue App
In Commercial Distribution

  • 00816486021183 ()
18312

  • Voice synthesizer/digitizer
TouchChat HD App
PRENTKE ROMICH COMPANY
TouchChat App
In Commercial Distribution

  • 00816486021053 ()
18626-4

  • Voice synthesizer/digitizer
Classic TouchChat App
PRENTKE ROMICH COMPANY
TouchChat App
In Commercial Distribution

  • 00816486021022 ()
18626-0

  • Voice synthesizer/digitizer
SmartView Connect App
MICROPORT CRM SRL
SW001U
In Commercial Distribution

  • 08031527019932 ()
SW001U

  • Cardiology information system application software
Kosmos Application loaded on an iPad.
ECHONOUS, INC.
iOS 4.X
Not in Commercial Distribution

  • 09353278000823 ()


  • Ultrasound imaging system application software
KOSMOS OTS iOS SOFTWARE PACKAGE [2.X]
ECHONOUS, INC.
P007944
In Commercial Distribution

  • 09353278000762 ()


  • Ultrasound imaging system application software
Stand alone software used to collect, store and print patient data on various iOS devices
Zoll Medical Corporation
ZEPCRU
In Commercial Distribution

  • 00847946021924 ()


  • Medical equipment clinical data interfacing software
reSET-O® Mobile Application running on iOS. reSET-O is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with opioid use disorder (OUD). The Introductory Access Limited Version provides limited access to the reSET-O product.
PEAR THERAPEUTICS, INC.
1
Not in Commercial Distribution

  • 10851580008170 ()


  • Mental health/function therapeutic software, screen-viewed
reSET® Mobile Application running on iOS. reSET is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with substance use disorder (SUD). The Introductory Access Limited Version provides limited access to the reSET product.
PEAR THERAPEUTICS, INC.
1
Not in Commercial Distribution

  • 10851580008149 ()


  • Mental health/function therapeutic software, screen-viewed
INSERT TRAY FOR 90,000 RPM PEN F/MODULAR GRAPHIC CASE F/EPD
SYNTHES (U.S.A.) LP
690.594
In Commercial Distribution

  • H6796905940R ()
  • 10886982254917 ()
690594

  • Surgical instrument/implant rack
INSERT TRAY FOR 60,000 RPM PEN F/MODULAR GRAPHIC CASE F/EPD
Synthes GmbH
690.587
In Commercial Distribution

  • H6796905870 ()
  • 10886982254795 ()
690587

  • Surgical instrument/implant rack
Pediatric EPD Femoral Angio Drape 75" x 125" w/Full Transparent Windows
ARGON MEDICAL DEVICES, INC.
396102
In Commercial Distribution

  • 20886333212426 ()
  • 00886333212422 ()

  • 75" x 125"
396102

  • Angiographic drape
Neonatal EPD Femoral Angio Drape 75" x 125" w/ Full Transparent Windows
ARGON MEDICAL DEVICES, INC.
396101
In Commercial Distribution

  • 20886333212419 ()
  • 00886333212415 ()

  • 75" x 125"
396101

  • Angiographic drape
Adult EPD Femoral Angio Drape 75" x 125" w/Full Transparent Windows
ARGON MEDICAL DEVICES, INC.
396100
In Commercial Distribution

  • 20886333212402 ()
  • 00886333212408 ()

  • 75" x 125"
396100

  • Angiographic drape
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Android devices (various manufacturers)
ELI LILLY AND COMPANY
MA9141 Android (Version 17)
In Commercial Distribution

  • 00300021458553 ()
MA9141001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices
ELI LILLY AND COMPANY
MA9142 IOS (Version 17)
In Commercial Distribution

  • 00300021451554 ()
MA9142001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices
ELI LILLY AND COMPANY
MA9162 IOS (Version 15)
In Commercial Distribution

  • 00300021286552 ()
MA9162001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Android devices (various manufacturers)
ELI LILLY AND COMPANY
MA9161 Android (Version 15)
In Commercial Distribution

  • 00300021285555 ()
MA9161001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices
ELI LILLY AND COMPANY
MA9160 IOS (Version 14)
In Commercial Distribution

  • 00300021284558 ()
MA9160001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Android devices (various manufacturers)
ELI LILLY AND COMPANY
MA9159 Android (Version 14)
In Commercial Distribution

  • 00300021283551 ()
MA9159001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
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