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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Mix2Vial 20/20mm W/20mic large filter TG S-Spike
WEST PHARMA. SERVICES IL, . LTD
8074022
In Commercial Distribution

  • 27290108240423 ()
  • 17290108240426 ()
  • 07290108240429 ()


  • Medication transfer needle, filtering
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

  • 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
XiVE® TG Titanium Bar Coping with Guide Pin
Dentsply Implants Manufacturing GmbH
32254241
Not in Commercial Distribution

25-4241

  • Dental implant suprastructure, permanent, preformed
XiVE® TG Gold Bar Coping with Guide Pin
Dentsply Implants Manufacturing GmbH
32254240
Not in Commercial Distribution

25-4240

  • Dental implant suprastructure, permanent, preformed
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)
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 Instruments Gesellschaft mit beschränkter Haftung
EIA-3708
In Commercial Distribution

  • 04048474037081 ()
EIA-3708

  • Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
05918081190
In Commercial Distribution

  • 07613336180877 ()
05918081190

  • Thyroglobulin IVD, control
iOS smartphone application for MODD1 Insulin Delivery System, software version v1.X
Modular Medical, Inc.
MODD1 Insulin Delivery System
In Commercial Distribution

  • 00850037806010 ()
MTL-103

  • Ambulatory insulin infusion pump software, patient-dosing
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
Eversense Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5501-02-300
In Commercial Distribution

  • 00817491023520 ()
FG-5501-02-300

  • Implantable glucose monitoring system
No Description
Thought Technology Ltd.
SA4520
In Commercial Distribution

  • 07540191000623 ()


  • Psychophysiological biofeedback system
TG Ab Ancillary Diluent - Atellica IM - CONS - 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995463
In Commercial Distribution

  • 00630414597904 ()
  • 00630414007304 ()
10995463

  • Buffered sample diluent IVD
4.8mm TG Hex Abutment Plastic Sleeve Hexed with Ti. Screw
TITAN IMPLANT INC
TN-48TGHAPSH
In Commercial Distribution

  • 00842448115621 ()


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