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,TUNER,TRUHEARING,3.5,IOS
Gn Hearing A/S
20681400
In Commercial Distribution

  • 05708296095568 ()


  • Hearing aid/implant system remote control
APP,GNH BEMORE,1.1,IOS
Gn Hearing A/S
20663900
In Commercial Distribution

  • 05708296095292 ()


  • Hearing aid/implant system remote control
APP,KS CHOICE,3.2.2,IOS
Gn Hearing A/S
20425400
In Commercial Distribution

  • 05708296076697 ()


  • Hearing aid/implant system remote control
APP,GNH TUNER,3.4,IOS
Gn Hearing A/S
20416900
In Commercial Distribution

  • 05708296074242 ()


  • Hearing aid/implant system remote control
APP,BT HEARP,3.4,IOS
Gn Hearing A/S
20416700
In Commercial Distribution

  • 05708296074228 ()


  • Hearing aid/implant system remote control
APP,RS SMART,3.4,IOS
Gn Hearing A/S
20416500
In Commercial Distribution

  • 05708296074204 ()


  • Hearing aid/implant system remote control
APP,GNH TUNER,3.3.2,IOS
Gn Hearing A/S
20402100
In Commercial Distribution

  • 05708296070831 ()


  • Hearing aid/implant system remote control
APP,BT HEARP,3.3.2,IOS
Gn Hearing A/S
20401900
In Commercial Distribution

  • 05708296070824 ()


  • Hearing aid/implant system remote control
APP,RS SMART,3.3.2,IOS
Gn Hearing A/S
20401700
In Commercial Distribution

  • 05708296070817 ()


  • Hearing aid/implant system remote control
APP,BT HEARMAX,1.0,IOS
Gn Hearing A/S
20410800
In Commercial Distribution

  • 05708296071531 ()


  • Hearing aid/implant system remote control
APP,RS CONTROL,1.0.6,IOS
Gn Hearing A/S
20409500
In Commercial Distribution

  • 05708296071432 ()


  • Hearing aid/implant system remote control
APP,MY LIVELY 1.4,IOS
Gn Hearing A/S
21123000
In Commercial Distribution

  • 05708296169702 ()


  • Hearing aid/implant system remote control
APP,KS DISCOVER,1.4,IOS
Gn Hearing A/S
20665200
In Commercial Distribution

  • 05708296164295 ()


  • Hearing aid/implant system remote control
APP,GNH TUNER,4.0,IOS
Gn Hearing A/S
20993600
In Commercial Distribution

  • 05708296158461 ()


  • Hearing aid/implant system remote control
APP,BT HEARP,4.0,IOS
Gn Hearing A/S
20993400
In Commercial Distribution

  • 05708296158447 ()


  • Hearing aid/implant system remote control
APP,RS SMART,4.0,IOS
Gn Hearing A/S
20993200
In Commercial Distribution

  • 05708296158423 ()


  • Hearing aid/implant system remote control
APP,KS CHOICE,4.0,IOS
Gn Hearing A/S
20993000
In Commercial Distribution

  • 05708296158409 ()


  • Hearing aid/implant system remote control
APP,JABRA,ENHANCE PRO,IOS
Gn Hearing A/S
21820200
In Commercial Distribution

  • 05708296214662 ()


  • Hearing aid/implant system remote control
BMS CT360 iOS Clinician App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 iOS Clinician App
Not in Commercial Distribution

  • 00851203006258 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
BMS CT360 iOS Patient App
BLUE SPARK TECHNOLOGIES, INC.
BMS CT360 iOS Patient App
Not in Commercial Distribution

  • 00851203006241 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
APP WIDEX REMOTE CARE IOS
Widex A/S
Remote Care 1.3.4
In Commercial Distribution

  • 05706069779707 ()
21035227

  • Hearing aid/implant system remote control
Tinnitus app iOS version 1.0
Widex A/S
Tinnitus app
In Commercial Distribution

  • 05706069674712 ()
5 300 0006 001

  • Tinnitus masking application software
BEYOND app iOS version 1.1
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069673562 ()
5 300 0004 001

  • Hearing aid/implant system remote control
VELYS Hip Navigation for iOS
DEPUY ORTHOPAEDICS, INC.
451580052
In Commercial Distribution

  • 10603295532040 ()
451580052

  • Orthopaedic stereotactic surgery system
MY TSF HOMECARE APP iOS
Smith & Nephew, Inc.
71075402
In Commercial Distribution

  • 00885556746387 ()
71075402

  • Wireless patient monitor/sensor reporting software, layperson-use
SFTWR MMT-6122 FOTA IOS V1.3.4
MEDTRONIC MINIMED, INC.
MMT-6122
In Commercial Distribution

  • 00763000532178 ()


  • Patient health record information system application software
No Description
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
Labat TG
In Commercial Distribution

  • 06971355420642 ()


  • General-purpose ultrasound imaging system
#13K/TG DE Curette/Chisel
HU-FRIEDY MFG. CO., LLC
S13K/TG
In Commercial Distribution

  • 10889950022549 ()
S13K/TG

  • Periodontal file/rasp, manual
VA 20mm FLL TG- VF
WEST PHARMA. SERVICES IL, . LTD
8072035
In Commercial Distribution

  • 27290108240652 ()
  • 17290108240655 ()
  • 07290108240658 ()


  • Vial/bottle adaptor, non-hermetic
XiVE® TG AuroBase D3.4-4.5
Dentsply Implants Manufacturing GmbH
32254520
In Commercial Distribution

25-4520

  • Dental implant suprastructure, permanent, preformed
XiVE® TG Abutment Screw
Dentsply Implants Manufacturing GmbH
32254300
In Commercial Distribution

25-4300

  • Dental implant suprastructure, permanent, preformed
XiVE® TG Castable Coping
Dentsply Implants Manufacturing GmbH
32254242
In Commercial Distribution

25-4242

  • Dental implant suprastructure kit
XiVE® TG Coping Screw
Dentsply Implants Manufacturing GmbH
32254200
In Commercial Distribution

25-4200

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

  • 00842448115560 ()


  • Dental implant abutment analog, laboratory
3.8mm Platform TG Implant Analog
TITAN IMPLANT INC
P-38TGIA-AL
In Commercial Distribution

  • 00842448116819 ()


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

  • 00842448112750 ()


  • Dental implant suprastructure, temporary, preformed, single-use
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
MINI ACCESS 4FR SS/TG
MEDLINE INDUSTRIES, INC.
DYNJMAST05
In Commercial Distribution

  • 40888277538871 ()
  • 10888277538870 ()
DYNJMAST05

  • 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
MINI ACCESS 5FR NT/TG
MEDLINE INDUSTRIES, INC.
DYNJMAST04
In Commercial Distribution

  • 40888277538864 ()
  • 10888277538863 ()
DYNJMAST04

  • General surgical procedure kit, non-medicated, reusable
TG Ab CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373706
In Commercial Distribution

  • 00630414971384 ()
LTGCVM

  • Thyroglobulin antibody IVD, control
TG Ab - CENTAUR - CTL - 2x3x2mL
Siemens Healthcare Diagnostics Inc.
10630917
In Commercial Distribution

  • 00630414587905 ()
10630917

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

  • 00636257156179 ()


  • Ankle/foot orthosis
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