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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RemoteLink 2 1.0.0 iOS
Sbo Hearing A/S
242484
In Commercial Distribution

  • 05714464058952 ()


  • Hearing aid/implant system remote control
Oticon RemoteCare 3.3.0 iOS
Sbo Hearing A/S
228209
In Commercial Distribution

  • 05714464012930 ()


  • Hearing aid/implant system remote control
RemoteLink Connect 3.3.0 iOS
Sbo Hearing A/S
228203
In Commercial Distribution

  • 05714464012879 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 2.5.0 IOS
Sbo Hearing A/S
228198
In Commercial Distribution

  • 05714464012824 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2.5.0 IOS
Sbo Hearing A/S
228196
In Commercial Distribution

  • 05714464012800 ()


  • Hearing aid/implant system remote control
OTICON ON 2.5.0 IOS
Sbo Hearing A/S
228193
In Commercial Distribution

  • 05714464012770 ()


  • Hearing aid/implant system remote control
OTICON ON 2.4.0 IOS
Sbo Hearing A/S
226657
In Commercial Distribution

  • 05714464012275 ()


  • Hearing aid/implant system remote control
Oticon RemoteCare 3.4.0 iOS
Sbo Hearing A/S
236788
In Commercial Distribution

  • 05714464042463 ()


  • Hearing aid/implant system remote control
RemoteLink Connect 3.4.0 iOS
Sbo Hearing A/S
234034
In Commercial Distribution

  • 05714464034673 ()


  • Hearing aid/implant system remote control
OTICON COMPANION 1.5.0 IOS
Sbo Hearing A/S
274919
In Commercial Distribution

  • 05714464146109 ()


  • Hearing aid/implant system remote control
SOUNDLINK 3 1.5.0 IOS
Sbo Hearing A/S
274915
In Commercial Distribution

  • 05714464146062 ()


  • Hearing aid/implant system remote control
REMOTELINK 2 1.5.0 IOS
Sbo Hearing A/S
274913
In Commercial Distribution

  • 05714464146048 ()


  • Hearing aid/implant system remote control
OTICON COMPANION 1.4.0 IOS
Sbo Hearing A/S
270493
In Commercial Distribution

  • 05714464139477 ()


  • Hearing aid/implant system remote control
SOUNDLINK 3 1.4.0 IOS
Sbo Hearing A/S
270491
In Commercial Distribution

  • 05714464139453 ()


  • Hearing aid/implant system remote control
REMOTELINK 2 1.4.0 IOS
Sbo Hearing A/S
270490
In Commercial Distribution

  • 05714464139446 ()


  • Hearing aid/implant system remote control
SOUNDLINK 3 1.3.0 IOS
Sbo Hearing A/S
269356
In Commercial Distribution

  • 05714464133963 ()


  • Hearing aid/implant system remote control
REMOTELINK 2 1.3.0 IOS
Sbo Hearing A/S
269354
In Commercial Distribution

  • 05714464133949 ()


  • Hearing aid/implant system remote control
OTICON COMPANION 1.3.0 IOS
Sbo Hearing A/S
269348
In Commercial Distribution

  • 05714464133888 ()


  • Hearing aid/implant system remote control
REMOTELINK 2 1.2.0 IOS
Sbo Hearing A/S
265710
In Commercial Distribution

  • 05714464127191 ()


  • Hearing aid/implant system remote control
OTICON COMPANION 1.2.0 IOS
Sbo Hearing A/S
265702
In Commercial Distribution

  • 05714464127139 ()


  • Hearing aid/implant system remote control
OTICON COMPANION 1.1.0 IOS
Sbo Hearing A/S
264790
In Commercial Distribution

  • 05714464125241 ()


  • Hearing aid/implant system remote control
SOUNDLINK 3 1.1.0 IOS
Sbo Hearing A/S
264786
In Commercial Distribution

  • 05714464125203 ()


  • Hearing aid/implant system remote control
REMOTELINK 2 1.1.0 IOS
Sbo Hearing A/S
264784
In Commercial Distribution

  • 05714464125180 ()


  • Hearing aid/implant system remote control
WVSM Management Suite - iOS
ATHENA GTX, INC.
iOS Software
In Commercial Distribution

  • B3943950006000 ()
395-0006-00

  • Centralized patient monitor
SEER 1000 IOS APPLICATION
Ge Medical Systems Information Technologies, Inc.
1000 IOS Application
In Commercial Distribution

  • 00840682116879 ()


  • Electrocardiographic ambulatory recorder
Vscan Air for iOS
GE Vingmed Ultrasound AS
Air for iOS
In Commercial Distribution

  • 00840682147071 ()


  • Ultrasound imaging system application software
On1 IOS Replica WP
Nobel Biocare AB
38742
In Commercial Distribution

  • 07332747213072 ()

  • Outer Diameter: 6.500 Millimeter
38742

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica RP
Nobel Biocare AB
38741
In Commercial Distribution

  • 07332747213065 ()

  • Outer Diameter: 5.300 Millimeter
38741

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica NP
Nobel Biocare AB
38740
In Commercial Distribution

  • 07332747213058 ()

  • Outer Diameter: 4.800 Millimeter
38740

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica WP
Nobel Biocare AB
38742
Not in Commercial Distribution

  • 07332747176278 ()

  • Outer Diameter: 6.500 Millimeter
38742

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica RP
Nobel Biocare AB
38741
Not in Commercial Distribution

  • 07332747176261 ()

  • Outer Diameter: 5.300 Millimeter
38741

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica NP
Nobel Biocare AB
38740
Not in Commercial Distribution

  • 07332747176254 ()

  • Outer Diameter: 4.800 Millimeter
38740

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica WP
Nobel Biocare AB
38742
In Commercial Distribution

  • 07332747113778 ()

  • Outer Diameter: 6.500 Millimeter
38742

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica RP
Nobel Biocare AB
38741
In Commercial Distribution

  • 07332747113761 ()

  • Outer Diameter: 5.300 Millimeter
38741

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica NP
Nobel Biocare AB
38740
In Commercial Distribution

  • 07332747113754 ()

  • Outer Diameter: 4.800 Millimeter
38740

  • Dental implant suprastructure, temporary, preformed, single-use
FreeStyle LibreLink iOS US
ABBOTT DIABETES CARE INC
71733-01
In Commercial Distribution

  • 00357599000059 ()
71733-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
No Description
Berman Instruments LLC
SS533
Not in Commercial Distribution

  • 00810060723449 ()


  • Manual dental scaler, reusable
No Description
Berman Instruments LLC
SS056
Not in Commercial Distribution

  • 00810060723425 ()


  • Manual dental scaler, reusable
SW APP 9735762 STEALTH S8 APP
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00643169865341 ()


  • Multi-purpose stereotactic surgery system
Multi-unit Abutment BL 2.9 H5
Rex Implants, Inc.
Multi-unit Abutment BL 2.9 H5
In Commercial Distribution

  • D894R4230 ()

  • Height: 5 Millimeter
  • Outer Diameter: 2.6 Millimeter
R4-23

  • Dental implant suprastructure, permanent, preformed
SCALERS ANTERIOR NV-1/H5 MINI
Power Dental U.S.A. Inc.
1225M
In Commercial Distribution

  • D9431225M00 ()
1225M

  • Dental excavator, reusable
  • Manual dental scaler, reusable
SCALERS JACQUETTE H5/33 TITANIUM
Power Dental U.S.A. Inc.
1203T
In Commercial Distribution

  • D9431203T0 ()
1203T

  • Dental excavator, reusable
  • Manual dental scaler, reusable
ORTHODONTIC, BAND SEAT OBP / H5
Power Dental U.S.A. Inc.
5894
In Commercial Distribution

  • D9435894 ()
5894

  • Dental amalgam carrier
  • Dental spatula, reusable
  • Orthodontic metal band pusher
H5 SCALER/#2 BAND PUSHER
HU-FRIEDY MFG. CO., LLC
BP5012
In Commercial Distribution

  • 10889950042585 ()
BP5012

  • Orthodontic metal band pusher
H5/PLGOR4 Scaler/Plugger, Serr
HU-FRIEDY MFG. CO., LLC
PLG5338
Not in Commercial Distribution

  • 10889950085841 ()


  • Endodontic plugger
#H5/LDG2 Ligature #6 Handle
HU-FRIEDY MFG. CO., LLC
PI7155
In Commercial Distribution

  • 10889950083533 ()
PI7155

  • Orthodontic ligature director
#H5 SE SCALER, SATIN STEEL
HU-FRIEDY MFG. CO., LLC
SC5418
In Commercial Distribution

  • 10889950093167 ()


  • Manual dental scaler, reusable
SATIN STEEL #H5/SN128 Scaler
HU-FRIEDY MFG. CO., LLC
SC43596
In Commercial Distribution

  • 10889950092207 ()


  • Manual dental scaler, reusable
#H5/GF21T SCALER - 2 HDL
HU-FRIEDY MFG. CO., LLC
SC1218
In Commercial Distribution

  • 10889950091071 ()


  • Manual dental scaler, reusable
#H5/0 MORSE SCALER DE
HU-FRIEDY MFG. CO., LLC
SC1197
In Commercial Distribution

  • 10889950090883 ()


  • Manual dental scaler, reusable
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