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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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
APP (Pads only)
COMPASS HEALTH BRANDS CORP.
SA901P
Not in Commercial Distribution

  • 00841447104070 ()
SA901P

  • Air-filled bed mattress overlay
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
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
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
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
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
FOP NM-10 is indicated for screening, capture and storage of images of the eye and surrounding area, FOP NM 10 camera is been designed for true colour and monochrome imaging in visible spectrum of light and consists of an incoherent light source. Light from the device is shown into the patient eye & the camera of a smart phone is used to capture images of the eye.
REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED
001
In Commercial Distribution

  • 08906096520014 ()


  • Ophthalmic fundus camera
  • Smartphone camera ophthalmic imaging lens
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
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
MA9158 IOS (Version 13)
In Commercial Distribution

  • 00300021177553 ()
MA9158001AM

  • 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
MA9152 Android (Version 13)
In Commercial Distribution

  • 00300021176556 ()
MA9152001AM

  • 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
MA9140 IOS (Version 12)
In Commercial Distribution

  • 00300021175559 ()
MA9140001AM

  • 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
MA9135 ANDROID (Version 12)
In Commercial Distribution

  • 00300021174552 ()
MA9135001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
SW 31302 CARELINK EXPRESS MOBILE IOS USA
MEDTRONIC, INC.
31302
In Commercial Distribution

  • 00643169636668 ()


  • Implantable cardiac device management application software
Mobile application compatible to iOS operating system
ST. JUDE MEDICAL, INC.
APP1005
In Commercial Distribution

  • 05415067032829 ()
APP1005

  • Implantable cardiac device management application software
DreamMapper iOS, North American Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054264 ()
1101478

  • Self-care monitoring/reporting software
Tandem t:slim Mobile Application, iOS version 2.9
Tandem Diabetes Care, Inc.
1014707
In Commercial Distribution

  • 00389152470740 ()


  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
Lumify Diagnostic Ultrasound System iOS Release 5.1
Philips Ultrasound LLC
795161
In Commercial Distribution

  • 00884838124141 ()


  • General-purpose ultrasound imaging system
NP IOS Model Implant Replica CC NP
Nobel Biocare AB
38189
Not in Commercial Distribution

  • 07332747175943 ()
38189

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 4 mm WP
Nobel Biocare AB
38739
In Commercial Distribution

  • 07332747191875 ()

  • Height: 4.000 Millimeter
38739

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 5 mm WP
Nobel Biocare AB
38738
In Commercial Distribution

  • 07332747191868 ()

  • Height: 5.000 Millimeter
38738

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 4.5 mm RP
Nobel Biocare AB
38737
In Commercial Distribution

  • 07332747191851 ()

  • Height: 4.500 Millimeter
38737

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 6 mm RP
Nobel Biocare AB
38736
In Commercial Distribution

  • 07332747191844 ()

  • Height: 6.000 Millimeter
38736

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 4.5 mm NP
Nobel Biocare AB
38735
In Commercial Distribution

  • 07332747191837 ()

  • Height: 4.500 Millimeter
38735

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Healing Cap 6 mm NP
Nobel Biocare AB
38734
In Commercial Distribution

  • 07332747191820 ()

  • Height: 6.000 Millimeter
38734

  • Dental implant suprastructure, temporary, preformed, single-use
NP IOS Model Implant Replica CC WP
Nobel Biocare AB
38191
Not in Commercial Distribution

  • 07332747175967 ()
38191

  • Dental implant suprastructure, temporary, preformed, single-use
NP IOS Model Implant Replica CC RP
Nobel Biocare AB
38190
Not in Commercial Distribution

  • 07332747175950 ()
38190

  • Dental implant suprastructure, temporary, preformed, single-use
NP IOS Model Implant Replica CC 3.0
Nobel Biocare AB
38188
Not in Commercial Distribution

  • 07332747175936 ()

  • Outer Diameter: 3.000 Millimeter
38188

  • Dental implant suprastructure, temporary, preformed, single-use
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