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 Class Implantable

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Accessories
CeramTec Schweiz GmbH
301250
In Commercial Distribution

  • 07640161394773 ()
301250

  • Dental implant suprastructure, temporary, preformed, single-use
Accessories
CeramTec Schweiz GmbH
301249
In Commercial Distribution

  • 07640161394766 ()
301249

  • Dental implant suprastructure, temporary, preformed, single-use
The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries. System includes one TST-11 tip.
3shape Trios A/S
L1P-1F
In Commercial Distribution

  • 05902729754149 ()


  • Intraoral optical scanning system
The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries. System includes five TST-11 tips.
3shape Trios A/S
L1P-1F
In Commercial Distribution

  • 05902729753722 ()


  • Intraoral optical scanning system
No Description
STARKEY LABORATORIES, INC.
“ProAkustik name” for iOS
In Commercial Distribution

  • 00842318130839 ()


  • Audiometric/hearing device software
No Description
STARKEY LABORATORIES, INC.
“KIND name” for iOS
In Commercial Distribution

  • 00842318130815 ()


  • Audiometric/hearing device software
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 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 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 Apple iOS devices
ELI LILLY AND COMPANY
MA9140 IOS (Version 12)
In Commercial Distribution

  • 00300021175559 ()
MA9140001AM

  • Medication reminder application software
  • Patient subjective symptom recorder
Care Assist
Philips Medical Systems Hsg
Care Assist iOS 4.2
In Commercial Distribution

  • 00884838123717 ()
989803221531

  • Centralized patient monitor
PAD, TABLE, 1.5" x 27" x 78"
DOMICO MED-DEVICE, LLC
173-20
In Commercial Distribution

  • 00810050244015 ()

  • Height: 1.5 Inch
  • Width: 27 Inch
  • Length: 78 Inch


  • Multifunction body cushion
  • Radiological general body-part positioner
PAD, TABLE, 1" x 24" x 60"
DOMICO MED-DEVICE, LLC
175-185
Not in Commercial Distribution

  • 00810050243766 ()

  • Height: 1 Inch
  • Width: 24 Inch
  • Length: 60 Inch


  • Multifunction body cushion
  • Radiological general body-part positioner
PAD, TABLE, 1" x 21" x 42"
DOMICO MED-DEVICE, LLC
174-184
In Commercial Distribution

  • 00810050243759 ()

  • Height: 1 Inch
  • Width: 21 Inch
  • Length: 42 Inch


  • Multifunction body cushion
  • Radiological general body-part positioner
PAD, TABLE, 1.50 X 27.00 X 78.00
DOMICO MED-DEVICE, LLC
173-183
In Commercial Distribution

  • 00810050241571 ()

  • Height: 1.50 Inch
  • Width: 27.00 Inch
  • Length: 78.00 Inch


  • Multifunction body cushion
  • Radiological general body-part positioner
PAD, TABLE, 1.00 X 27.00 X 78.00
DOMICO MED-DEVICE, LLC
176-186
In Commercial Distribution

  • 00810050241533 ()

  • Height: 1 Inch
  • Width: 27 Inch
  • Length: 78 Inch


  • Multifunction body cushion
  • Radiological general body-part positioner
PAD, TABLE, 1.25" x 26" x 78"
DOMICO MED-DEVICE, LLC
172-20
In Commercial Distribution

  • 00810050240888 ()

  • Height: 1.25 Inch
  • Width: 26 Inch
  • Length: 78 Inch


  • Multifunction body cushion
  • Radiological general body-part positioner
PAD, TABLE, 1.25 X 26.00 X 78.00
DOMICO MED-DEVICE, LLC
172-182
In Commercial Distribution

  • 00810050241564 ()

  • Height: 1.25 Inch
  • Width: 26.00 Inch
  • Length: 78.00 Inch


  • Multifunction body cushion
  • Radiological general body-part positioner
PAD, TABLE, 1.00 X 27.00 X 78.00
DOMICO MED-DEVICE, LLC
176-20
In Commercial Distribution

  • 00810050241540 ()

  • Height: 1.00 Inch
  • Width: 27.00 Inch
  • Length: 78.00 Inch


  • Multifunction body cushion
  • Radiological general body-part positioner
PAD, TABLE, 1.00 X 24.00 X 72.00
DOMICO MED-DEVICE, LLC
171-181
In Commercial Distribution

  • 00810050241526 ()

  • Height: 1 Inch
  • Width: 24 Inch
  • Length: 72 Inch


  • Multifunction body cushion
  • Radiological general body-part positioner
PAD, TABLE, 1" x 24" x 72"
DOMICO MED-DEVICE, LLC
171-20
In Commercial Distribution

  • 00810050240871 ()

  • Height: 1 Inch
  • Width: 24 Inch
  • Length: 72 Inch


  • Multifunction body cushion
  • Radiological general body-part positioner
The Glooko Mobile application for iOS and Android displays retrospective data that is captured from BG meters, insulin pumps and continuous glucose monitors (CGM)
GLOOKO, INC.
5.xx
In Commercial Distribution

  • 00855093008033 ()


  • Clinical management support 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
Dedicated speech generating device utilizing synthesized speech, permitting multiple methods of message formulation and multiple methods of device access based on Apple iOS operating system.
RM SPEECH
RMNXS
In Commercial Distribution

  • B660RMNXS0 ()


  • Voice synthesizer/digitizer
Dedicated speech generating device utilizing synthesized speech, permitting multiple methods of message formulation and multiple methods of device access based on Apple iOS operating system.
RM SPEECH
RMNXL
In Commercial Distribution

  • B660RMNXL0 ()


  • Voice synthesizer/digitizer
Dedicated speech generating device utilizing synthesized speech, permitting multiple methods of message formulation and multiple methods of device access based on Apple iOS operating system.
RM SPEECH
RMNS
In Commercial Distribution

  • B660RMNS0 ()


  • Voice synthesizer/digitizer
Dedicated speech generating device utilizing synthesized speech, permitting multiple methods of message formulation and multiple methods of device access based on Apple iOS operating system.
RM SPEECH
RMN
In Commercial Distribution

  • B660RMN0 ()


  • Voice synthesizer/digitizer
No Description
STARKEY LABORATORIES, INC.
Thrive Hearing Control for iOS
In Commercial Distribution

  • 00842318130792 ()


  • Audiometric/hearing device software
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