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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XiVE® TG Gold Bar Coping with Guide Pin
Dentsply Implants Manufacturing GmbH
32254240
Not in Commercial Distribution

  • EFRI322542402 ()
25-4240

  • Dental implant suprastructure, permanent, preformed
LOCATOR Abutment for Platform "M" Premium TG x 5.0mm
Zest Anchors, LLC
2092
In Commercial Distribution

  • 00840481117879 ()

  • Length: 5 Millimeter
2092

  • Dental implant suprastructure, permanent, preformed
LOCATOR Abutment for Platform "M" Premium TG x 4.0mm
Zest Anchors, LLC
2091
In Commercial Distribution

  • 00840481117862 ()

  • Length: 4 Millimeter
2091

  • Dental implant suprastructure, permanent, preformed
LOCATOR Abutment for Platform "M" Premium TG x 3.0mm
Zest Anchors, LLC
2090
In Commercial Distribution

  • 00840481117855 ()

  • Length: 3 Millimeter
2090

  • Dental implant suprastructure, permanent, preformed
LOCATOR Abutment for Platform "W" Premium TG x 6.0mm
Zest Anchors, LLC
2086
In Commercial Distribution

  • 00840481117817 ()

  • Length: 6 Millimeter
2086

  • Dental implant suprastructure, permanent, preformed
LOCATOR Abutment for Platform "W" Premium TG x 5.0mm
Zest Anchors, LLC
2085
In Commercial Distribution

  • 00840481117800 ()

  • Length: 5 Millimeter
2085

  • Dental implant suprastructure, permanent, preformed
LOCATOR Abutment for Platform "W" Premium TG x 4.0mm
Zest Anchors, LLC
2084
In Commercial Distribution

  • 00840481117794 ()

  • Length: 4 Millimeter
2084

  • Dental implant suprastructure, permanent, preformed
LOCATOR Abutment for Platform "W" Premium TG x 3.0mm
Zest Anchors, LLC
2083
In Commercial Distribution

  • 00840481117787 ()

  • Length: 3 Millimeter
2083

  • Dental implant suprastructure, permanent, preformed
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
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
Mix2Vial™ 20/20mm w/15µm Large Filter TG
WEST PHARMA. SERVICES IL, . LTD
8074046
In Commercial Distribution

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


  • Medication transfer needle, filtering
Mobile version
3DIEMME SRL
RealGUIDE APP
In Commercial Distribution

  • 08050038830003 ()


  • CAD/CAM software
No Description
Pjama AB
DryGuardians App
In Commercial Distribution

  • 07350078445160 ()
4200

  • Incontinence sensor/alarm
No Description
Clarius Mobile Health Corp
App - Android
In Commercial Distribution

  • 07540205000403 ()
12-01-00004

  • Ultrasound imaging system application software
  • Radiological PACS software
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)
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
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
FeetMe Rehabilitation mobile application corresponding to iOS version 1.Y.Z
FEETME
1
In Commercial Distribution

  • 03760349820024 ()


  • Biomechanical function analysis/rehabilitation software
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

  • 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 RP
Nobel Biocare AB
301025
In Commercial Distribution

  • 07332747214406 ()
301025

  • 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
Bluetooth Basal Thermometer with Ovy App
BEURER NORTH AMERICA, L.P.
OT30
In Commercial Distribution

  • 00850003500560 ()
791.77

  • Thermometric fertility analyser
MAJ-1352 BALLOON APP. FOR EBUS BRONCHSCP
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1352
In Commercial Distribution

  • 04953170355981 ()


  • Surgical instrument assist arm system, manually-adjusted
CB RING KIT TI SM-No App
OSSUR AMERICAS, INC.
515300T
Not in Commercial Distribution

  • 05690977334960 ()
515300T

  • Cervical spine immobilization head ring
CB RING KIT TI LG-No App
OSSUR AMERICAS, INC.
515500T
Not in Commercial Distribution

  • 05690977326200 ()
515500T

  • Cervical spine immobilization head ring
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