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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APP, Bluetooth, otoTune iOS for self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990019-SWH
In Commercial Distribution

  • 00850016231383 ()


  • Audiometric/hearing device software
US Dexcom Follow App for iOS, (mg/dL), v4
Dexcom, Inc.
SW10497
In Commercial Distribution

  • 00386270001931 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
t:connect Mobile Application, Mobile Bolus Enabled, 2.x (iOS)
Tandem Diabetes Care, Inc.
1007111
In Commercial Distribution

  • 90850018992452 ()


  • Ambulatory insulin infusion pump software, data-display
  • Ambulatory insulin infusion pump remote control
IOS Implant Replica Nobel Biocare N1™ TCC RP
Nobel Biocare AB
300965
In Commercial Distribution

  • 07332747162899 ()
300965

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Implant Replica Nobel Biocare N1™ TCC NP
Nobel Biocare AB
300964
In Commercial Distribution

  • 07332747162882 ()
300964

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Implant Replica Nobel Biocare N1™ TCC RP
Nobel Biocare AB
300965
In Commercial Distribution

  • 07332747177008 ()
300965

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Implant Replica Nobel Biocare N1™ TCC NP
Nobel Biocare AB
300964
In Commercial Distribution

  • 07332747176995 ()
300964

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Implant Replica Nobel Biocare N1™ TCC RP
Nobel Biocare AB
300965
In Commercial Distribution

  • 07332747214222 ()
300965

  • Dental implant suprastructure, temporary, preformed, single-use
IOS Implant Replica Nobel Biocare N1™ TCC NP
Nobel Biocare AB
300964
In Commercial Distribution

  • 07332747214215 ()
300964

  • Dental implant suprastructure, temporary, preformed, single-use
Anti-TG Ab is an ELISA test system for the quantitative measurement of IgG class autoantibodies against thyroglobulin (TG) in human serum or plasma.
DRG International Inc
EIA-3708
In Commercial Distribution

  • 00840239037084 ()
EIA-3708

  • Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA)
PREMIUM IMPLANT ZIRTI TG D.5.00 H.10 MM
SWEDEN & MARTINA SPA
A-ZT-500TG-100
In Commercial Distribution

  • D7700868453 ()
A-ZT-500TG-100

  • Screw endosteal dental implant, two-piece
PREMIUM IMPLANT ZIRTI TG D.4.25 H.11.5 MM
SWEDEN & MARTINA SPA
A-ZT-425TG-115
In Commercial Distribution

  • D7700868413 ()
A-ZT-425TG-115

  • Screw endosteal dental implant, two-piece
PREMIUM IMPLANT ZIRTI TG D.4.25 H.8.5 MM
SWEDEN & MARTINA SPA
A-ZT-425TG-085
In Commercial Distribution

  • D7700868393 ()
A-ZT-425TG-085

  • Screw endosteal dental implant, two-piece
PREMIUM IMPLANT ZIRTI TG D.3.80 H.7 MM
SWEDEN & MARTINA SPA
A-ZT-380TG-070
In Commercial Distribution

  • D7700868363 ()
A-ZT-380TG-070

  • Screw endosteal dental implant, two-piece
PREMIUM IMPLANT ZIRTI TG D.3.80 H.6 MM
SWEDEN & MARTINA SPA
A-ZT-380TG-060
In Commercial Distribution

  • D7700868353 ()
A-ZT-380TG-060

  • Screw endosteal dental implant, two-piece
PREMIUM IMPLANT ZIRTI TG D.3.30 H.11.5 MM
SWEDEN & MARTINA SPA
A-ZT-330TG-115
In Commercial Distribution

  • D7700868343 ()
A-ZT-330TG-115

  • Screw endosteal dental implant, two-piece
PREMIUM IMPLANT ZIRTI TG D.5.00 H.11.5 MM
SWEDEN & MARTINA SPA
A-ZT-500TG-115
In Commercial Distribution

  • D7700855673 ()
A-ZT-500TG-115

  • Screw endosteal dental implant, two-piece
PREMIUM IMPLANT ZIRTI TG D.5.00 H.8.5 MM
SWEDEN & MARTINA SPA
A-ZT-500TG-085
In Commercial Distribution

  • D7700855663 ()
A-ZT-500TG-085

  • Screw endosteal dental implant, two-piece
PREMIUM IMPLANT ZIRTI TG D.4.25 H.15 MM
SWEDEN & MARTINA SPA
A-ZT-425TG-150
In Commercial Distribution

  • D7700855653 ()
A-ZT-425TG-150

  • Screw endosteal dental implant, two-piece
PREMIUM IMPLANT ZIRTI TG D.3.80 H.15 MM
SWEDEN & MARTINA SPA
A-ZT-380TG-150
In Commercial Distribution

  • D7700855643 ()
A-ZT-380TG-150

  • Screw endosteal dental implant, two-piece
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