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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No Description
Sugarmate, LLC
1007228
In Commercial Distribution

  • 00850018992435 ()


  • Self-care monitoring/reporting software
Clinical decision support software indicated for use by licensed clinicians to inform the detection of disease utilizing an iOS client.
AMBIENT CLINICAL ANALYTICS, INC.
1.0
In Commercial Distribution

  • 00850893007033 ()


  • Clinical management support software
No Description
Philips Ultrasound LLC
795161
In Commercial Distribution

  • 00884838103405 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
Mobile Application Remote Control
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52603
In Commercial Distribution

  • 09008737526030 ()


  • Audiometric/hearing device software
No Description
BIOSERENITY MEDICAL DEVICES GROUP
5100-00012
Not in Commercial Distribution

  • 03615220002610 ()


  • Electroencephalographic monitoring system
FeetMe Rehabilitation mobile application corresponding to iOS version 1.Y.Z
FEETME
1
In Commercial Distribution

  • 03760349820024 ()


  • Biomechanical function analysis/rehabilitation software
IOS Healing Abutment Nobel Biocare N1™ Base Tri RP
Nobel Biocare AB
300992
In Commercial Distribution

  • 07332747192797 ()
300992

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Healing Abutment Nobel Biocare N1™ Base Tri NP
Nobel Biocare AB
300991
In Commercial Distribution

  • 07332747192780 ()
300991

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Base Replica Nobel Biocare N1™ Base Tri RP
Nobel Biocare AB
301025
In Commercial Distribution

  • 07332747177169 ()
301025

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Base Replica Nobel Biocare N1™ Base Tri NP
Nobel Biocare AB
301024
In Commercial Distribution

  • 07332747177152 ()
301024

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Base Replica Nobel Biocare N1™ Base Tri RP
Nobel Biocare AB
301025
In Commercial Distribution

  • 07332747163148 ()
301025

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Base Replica Nobel Biocare N1™ Base Tri NP
Nobel Biocare AB
301024
In Commercial Distribution

  • 07332747163131 ()
301024

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Healing Abutment Nobel Biocare N1™ Base Tri RP
Nobel Biocare AB
300992
In Commercial Distribution

  • 07332747162967 ()
300992

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Healing Abutment Nobel Biocare N1™ Base Tri NP
Nobel Biocare AB
300991
In Commercial Distribution

  • 07332747162950 ()
300991

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Base Replica Nobel Biocare N1™ Base Tri RP
Nobel Biocare AB
301025
In Commercial Distribution

  • 07332747214406 ()
301025

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Base Replica Nobel Biocare N1™ Base Tri NP
Nobel Biocare AB
301024
In Commercial Distribution

  • 07332747214390 ()
301024

  • Dental implant suprastructure, temporary, preformed, single-use
Bluetooth Basal Thermometer with Ovy App
BEURER NORTH AMERICA, L.P.
OT30
In Commercial Distribution

  • 00850003500560 ()
791.77

  • Thermometric fertility analyser
MAJ-1352 BALLOON APP. FOR EBUS BRONCHSCP
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1352
In Commercial Distribution

  • 04953170355981 ()


  • Surgical instrument assist arm system, manually-adjusted
CB RING KIT TI SM-No App
OSSUR AMERICAS, INC.
515300T
Not in Commercial Distribution

  • 05690977334960 ()
515300T

  • Cervical spine immobilization head ring
CB RING KIT TI LG-No App
OSSUR AMERICAS, INC.
515500T
Not in Commercial Distribution

  • 05690977326200 ()
515500T

  • Cervical spine immobilization head ring
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