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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PREMIUM IMPLANT ZIRTI TG D.5.00 H.6 MM
SWEDEN & MARTINA SPA
A-ZT-500TG-060
In Commercial Distribution

  • D7700868433 ()
A-ZT-500TG-060

  • Screw endosteal dental implant, two-piece
PREMIUM IMPLANT ZIRTI TG D.4.25 H.13 MM
SWEDEN & MARTINA SPA
A-ZT-425TG-130
In Commercial Distribution

  • D7700868423 ()
A-ZT-425TG-130

  • 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.4.25 H.6 MM
SWEDEN & MARTINA SPA
A-ZT-425TG-060
In Commercial Distribution

  • D7700868373 ()
A-ZT-425TG-060

  • 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.3.80 H.13 MM
SWEDEN & MARTINA SPA
A-ZT-380TG-130
In Commercial Distribution

  • D7700855633 ()
A-ZT-380TG-130

  • Screw endosteal dental implant, two-piece
PREMIUM IMPLANT ZIRTI TG D.3.80 H.11.5 MM
SWEDEN & MARTINA SPA
A-ZT-380TG-115
In Commercial Distribution

  • D7700855623 ()
A-ZT-380TG-115

  • Screw endosteal dental implant, two-piece
PREMIUM IMPLANT ZIRTI TG D.3.80 H.10 MM
SWEDEN & MARTINA SPA
A-ZT-380TG-100
In Commercial Distribution

  • D7700855613 ()
A-ZT-380TG-100

  • Screw endosteal dental implant, two-piece
PREMIUM IMPLANT ZIRTI TG D.3.80 H.8.5 MM
SWEDEN & MARTINA SPA
A-ZT-380TG-085
In Commercial Distribution

  • D7700855603 ()
A-ZT-380TG-085

  • Screw endosteal dental implant, two-piece
PREMIUM IMPLANT ZIRTI TG D.3.30 H.15 MM
SWEDEN & MARTINA SPA
A-ZT-330TG-150
In Commercial Distribution

  • D7700855593 ()
A-ZT-330TG-150

  • Screw endosteal dental implant, two-piece
PREMIUM IMPLANT ZIRTI TG D.3.30 H.10 MM
SWEDEN & MARTINA SPA
A-ZT-330TG-100
In Commercial Distribution

  • D7700855573 ()
A-ZT-330TG-100

  • Screw endosteal dental implant, two-piece
Periodontal Surgical chisel, double-ended, modif. TG with Ochsenbein cutouts
A. TITAN INSTRUMENTS, INC.
CTG-0
In Commercial Distribution

  • 00841685109097 ()


  • Dental osteotome
Periodontal chisel # 13K/TG "Kirkland" COMFORT | SL | double ended
devemed GmbH
02-KL 13K-TG C
In Commercial Distribution

  • 04061644036561 ()


  • Orthopaedic chisel
Periodontal chisel # 13K/TG "Kirkland" F-LINE | SL | double ended
devemed GmbH
KL 13K-TG F
In Commercial Distribution

  • 04061644022250 ()


  • Orthopaedic chisel
Mix2Vial™ 20/20mm w/15µm Large Filter TG
WEST PHARMA. SERVICES IL, . LTD
8074046
In Commercial Distribution

  • 27290108240997 ()
  • 17290108240990 ()
  • 07290108240993 ()


  • Medication transfer needle, filtering
VA 20mm FLL SIL w/25μm Filter TG - VF
WEST PHARMA. SERVICES IL, . LTD
8072114
In Commercial Distribution

  • 27290108240669 ()
  • 17290108240662 ()
  • 07290108240665 ()


  • Vial/bottle adaptor, non-hermetic
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
Vial Adapter 20mm ML TG SS Blue SIL- VF
WEST PHARMA. SERVICES IL, . LTD
8072028
Not in Commercial Distribution

  • 27290108240003 ()
  • 17290108240006 ()
  • 07290108240009 ()


  • Vial/bottle adaptor, non-hermetic
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)
No Description
Roche Diagnostics GmbH
05918081190
In Commercial Distribution

  • 07613336180877 ()
05918081190

  • Thyroglobulin IVD, control
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
Sugarmate, LLC
1007228
In Commercial Distribution

  • 00850018992435 ()


  • Self-care monitoring/reporting software
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
Mobile Application Remote Control
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52603
In Commercial Distribution

  • 09008737526030 ()


  • Audiometric/hearing device software
No Description
Philips Ultrasound LLC
795161
In Commercial Distribution

  • 00884838103405 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
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
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
FeetMe Rehabilitation mobile application corresponding to iOS version 1.Y.Z
FEETME
1
In Commercial Distribution

  • 03760349820024 ()


  • Biomechanical function analysis/rehabilitation software
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 NP
Nobel Biocare AB
301024
In Commercial Distribution

  • 07332747214390 ()
301024

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

  • 07332747214406 ()
301025

  • Dental implant suprastructure, temporary, preformed, single-use
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
LOCATOR ABUTMENT PRE/KOH TG MEDIUM PLATFORM, H. 2 MM
SWEDEN & MARTINA SPA
2089
In Commercial Distribution

  • 00840481117848 ()
2089

  • Dental implant suprastructure, permanent, preformed
LOCATOR ABUTMENT PRE/KOH TG MEDIUM PLATFORM, H. 1 MM
SWEDEN & MARTINA SPA
2088
In Commercial Distribution

  • 00840481117831 ()
2088

  • Dental implant suprastructure, permanent, preformed
LOCATOR ABUTMENT PRE/KOH TG MEDIUM PLATFORM, H. 0.2 MM
SWEDEN & MARTINA SPA
2087
In Commercial Distribution

  • 00840481117824 ()
2087

  • Dental implant suprastructure, permanent, preformed
LOCATOR ABUTMENT PRE/KOH TG WIDE PLATFORM, H.2 MM
SWEDEN & MARTINA SPA
2082
In Commercial Distribution

  • 00840481117770 ()
2082

  • Dental implant suprastructure, permanent, preformed
LOCATOR ABUTMENT PRE/KOH TG MEDIUM PLATFORM, H. 1.25 MM
SWEDEN & MARTINA SPA
2081
In Commercial Distribution

  • 00840481117763 ()
2081

  • Dental implant suprastructure, permanent, preformed
CASTABLE CAP FOR PREMADE POSTS REP., PRE-KOH TG, MEDIUM PLAT.
SWEDEN & MARTINA SPA
A-TG-CAPCM-M
In Commercial Distribution

  • D7700875003 ()
A-TG-CAPCM-M

  • Dental implant suprastructure, permanent, preformed
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