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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Lingo Biosensor iOS App US
ABBOTT DIABETES CARE INC
78783-01
In Commercial Distribution

  • 00357599849009 ()
78783-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Wide Neck TG Fixture Mount
TITAN IMPLANT INC
ITI-WNTGM
In Commercial Distribution

  • 00842448103475 ()


  • Dental implant system
Standard Diameter TG Fixture Mount
TITAN IMPLANT INC
ITI-STGM
In Commercial Distribution

  • 00842448103444 ()


  • Dental implant system
MINI ACCESS 4FR SS/TG
MEDLINE INDUSTRIES, INC.
DYNJMAST05
In Commercial Distribution

  • 40888277538871 ()
  • 10888277538870 ()
DYNJMAST05

  • General surgical procedure kit, non-medicated, reusable
MINI ACCESS 5FR NT/TG
MEDLINE INDUSTRIES, INC.
DYNJMAST04
In Commercial Distribution

  • 40888277538864 ()
  • 10888277538863 ()
DYNJMAST04

  • General surgical procedure kit, non-medicated, reusable
MINI ACCESS 4FR NT/TG
MEDLINE INDUSTRIES, INC.
DYNJMAST03
In Commercial Distribution

  • 40888277538857 ()
  • 10888277538856 ()
DYNJMAST03

  • General surgical procedure kit, non-medicated, reusable
Kosmos OTS iOS Software Package
ECHONOUS, INC.
P007639
In Commercial Distribution

  • 09353278000717 ()


  • Ultrasound imaging system application software
IOS VMAX SERIES OPTION-ICU CART
VYAIRE MEDICAL, INC.
776268-103
In Commercial Distribution

  • 10190752164154 ()
776268-103

  • Neonatal/adult intensive-care ventilator
DreamMapper Mobile Application iOS EMEA
Respironics, Inc.
2.8
In Commercial Distribution

  • 00606959047532 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper Mobile Application iOS EMEA
Respironics, Inc.
2.5
In Commercial Distribution

  • 00606959042018 ()
1128264

  • Self-care monitoring/reporting software
4.8mm TG Hex Abutment Screw
TITAN IMPLANT INC
T-48TGHAS
In Commercial Distribution

  • 00842448109842 ()


  • Dental prosthesis/implant abutment screw
4.8mm TG Hex Abutment Analog
TITAN IMPLANT INC
T-48TGHAA
In Commercial Distribution

  • 00842448109835 ()


  • Dental implant abutment analog, laboratory
DreamMapper Mobile Application iOS EMEA
Respironics, Inc.
2.7
In Commercial Distribution

  • 00606959046818 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper Mobile Application iOS EMEA
Respironics, Inc.
2.6
In Commercial Distribution

  • 00606959044401 ()
1128264

  • Self-care monitoring/reporting software
XiVE® TG AuroBase D3.4-4.5
Dentsply Implants Manufacturing GmbH
32254520
Not in Commercial Distribution

  • EFRI322545202 ()
25-4520

  • Dental implant suprastructure, permanent, preformed
XiVE® TG Abutment Screw
Dentsply Implants Manufacturing GmbH
32254300
Not in Commercial Distribution

  • EFRI322543002 ()
25-4300

  • Dental implant suprastructure, permanent, preformed
XiVE® TG Castable Coping
Dentsply Implants Manufacturing GmbH
32254242
Not in Commercial Distribution

  • EFRI322542422 ()
25-4242

  • Dental implant suprastructure kit
XiVE® TG Coping Screw
Dentsply Implants Manufacturing GmbH
32254200
Not in Commercial Distribution

  • EFRI322542002 ()
25-4200

  • Dental implant suprastructure, permanent, preformed
3.8mm Platform TG Implant Analog
TITAN IMPLANT INC
P-38TGIA-AL
In Commercial Distribution

  • 00842448116819 ()


  • Dental implant analog
6.5mm TG Hex Abutment Analog
TITAN IMPLANT INC
TN2-65TGHAA-AL
In Commercial Distribution

  • 00842448115560 ()


  • Dental implant abutment analog, laboratory
4.8mm TG Non-Locking Temporary Abutment
TITAN IMPLANT INC
T-TGTNLA
In Commercial Distribution

  • 00842448112750 ()


  • Dental implant suprastructure, temporary, preformed, single-use
iOS Hearing Aid Programming App
HEARX GROUP (PTY) LTD
Lexie iOS App
In Commercial Distribution

  • 00850022464263 ()
Lexie iOS App

  • Audiometric/hearing device software
TG Ab - CENTAUR - CTL - 2x3x2mL
Siemens Healthcare Diagnostics Inc.
10630917
In Commercial Distribution

  • 00630414587905 ()
10630917

  • Thyroglobulin antibody IVD, control
TG Ab CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373706
In Commercial Distribution

  • 00630414971384 ()
LTGCVM

  • Thyroglobulin antibody IVD, control
TG PRO TACO XS-S STRAP
MEDI MANUFACTURING, INC.
200963
Not in Commercial Distribution

  • 00636257156179 ()


  • Ankle/foot orthosis
TG PRO TACO XXS STRAP
MEDI MANUFACTURING, INC.
200903
Not in Commercial Distribution

  • 00636257156162 ()


  • Ankle/foot orthosis
TG PRO TACO L-XL STRAP
MEDI MANUFACTURING, INC.
200146
Not in Commercial Distribution

  • 00636257156117 ()


  • Ankle/foot orthosis
TG PRO TACO M STRAP
MEDI MANUFACTURING, INC.
200145
Not in Commercial Distribution

  • 00636257156100 ()


  • Ankle/foot orthosis
SW M01A02 CARELINK SMARTSYNC IOS
MEDTRONIC, INC.
M01A02
In Commercial Distribution

  • 00643169833739 ()


  • Implantable cardiac device management application software
PERIO CHISEL TG - DURALITE HAN
NORDENT MANUFACTURING INC
ECPTG
In Commercial Distribution

  • 00840018641686 ()


  • Periodontal hoe
PERIO CHISEL, MODIFIED TG, OCH
NORDENT MANUFACTURING INC
CPTG-O
In Commercial Distribution

  • 00840018641488 ()


  • Periodontal hoe
PERIO CHISEL - TG DOUBLE END
NORDENT MANUFACTURING INC
CPTG
In Commercial Distribution

  • 00840018641471 ()


  • Periodontal hoe
Vscan Air R3 for iOS
GE Vingmed Ultrasound AS
Air R3 for iOS
In Commercial Distribution

  • 00195278884749 ()


  • Ultrasound imaging system application software
Vscan Air R2 for iOS
GE Vingmed Ultrasound AS
Air R2 for iOS
In Commercial Distribution

  • 00195278640550 ()


  • Ultrasound imaging system application software
POST SCREW M1.4 PRE-KOH TG
SWEDEN & MARTINA SPA
A-TG-VP-140
In Commercial Distribution

  • D7700880493 ()
A-TG-VP-140

  • Dental implant suprastructure, permanent, preformed
2mm Guide Pin, TG (Single)
ARTHROSURFACE INCORPORATED
7007-1300
In Commercial Distribution

  • M528700713000 ()
7007-1300

  • Orthopaedic bone wire
PLS13K/TG KIRKLAND CHISEL 1P
Peter Brasseler Holdings, LLC
5025458U0
In Commercial Distribution

  • 00887919759911 ()


  • Dental osteotome
HFX 2.0 Patient Application (iOS)
NEVRO CORP.
PTA10043
In Commercial Distribution

  • 00813426021135 ()


  • Implantable electrical stimulation device management software
HFX iQ Patient Application (iOS)
NEVRO CORP.
PTA10043
In Commercial Distribution

  • 00813426020817 ()
PTA10043

  • Implantable electrical stimulation device management software
VELYS Hip Navigation for iOS
DEPUY ORTHOPAEDICS, INC.
451580052
In Commercial Distribution

  • 10603295532040 ()
451580052

  • Orthopaedic stereotactic surgery system
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