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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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
ACIF Trial - W20xL16, H5/H6mm
CTL Medical Corporation
013.7425
In Commercial Distribution

  • 00841732122130 ()


  • General internal orthopaedic fixation system implantation kit
RE H5 Revax Lab Key
Preat Corporation
2RT00H5
In Commercial Distribution

  • 00842092109700 ()
2RT00H5

  • Dental implant holding endpiece, reusable
MaxiGrip Scaler DE H5/33
HENRY SCHEIN, INC.
9005024
In Commercial Distribution

  • 00304040050231 ()
9005024

  • Manual dental scaler, reusable
Acclean Scaler DE Sickle H5
HENRY SCHEIN, INC.
5703779
In Commercial Distribution

  • 00304040184929 ()
5703779

  • Manual dental scaler, reusable
Acclean Scaler DE Sickle H5
HENRY SCHEIN, INC.
5703778
In Commercial Distribution

  • 00304040184912 ()
5703778

  • Manual dental scaler, reusable
Acclean Scaler Sickle H5/Hoe
HENRY SCHEIN, INC.
5703777
In Commercial Distribution

  • 00304040184905 ()
5703777

  • Manual dental scaler, reusable
BAND PUSHER/SCALER #H5 HOLLOW
J & J INSTRUMENTS INC
77-822
In Commercial Distribution

  • 00817524029482 ()


  • Orthodontic metal band pusher
CERVICAL CAGE 14X17 H5 mm
LDR Spine Usa, Inc.
MC131P
In Commercial Distribution

  • 03662663021234 ()

  • Width: 17 Millimeter
  • Depth: 14 Millimeter
  • Height: 5 Millimeter


  • Polymeric spinal fusion cage, sterile
CERVICAL CAGE 14X14 H5 mm
LDR Spine Usa, Inc.
MC111P
In Commercial Distribution

  • 03662663021166 ()

  • Width: 14 Millimeter
  • Depth: 14 Millimeter
  • Height: 5 Millimeter


  • Polymeric spinal fusion cage, sterile
ROI-C MONOBLOCK TRIAL 14X17 H5
LDR Spine Usa, Inc.
MC9039R
In Commercial Distribution

  • 03662663043502 ()

  • Height: 5 Millimeter
  • Width: 17 Millimeter
  • Depth: 14 Millimeter
MC9039R

  • Spinal implant trial
ROI-C MONOBLOCK TRIAL 12X14 H5
LDR Spine Usa, Inc.
MC9011R
In Commercial Distribution

  • 03662663043212 ()

  • Depth: 12 Millimeter
  • Width: 14 Millimeter
  • Height: 5 Millimeter
MC9011R

  • Spinal implant trial
CLOSED CERVICAL CAGE 12X14 H5
LDR Spine Usa, Inc.
MC341P
In Commercial Distribution

  • 03662663021555 ()

  • Width: 14 Millimeter
  • Depth: 12 Millimeter
  • Height: 5 Millimeter


  • Polymeric spinal fusion cage, sterile
CLOSED CERVICAL CAGE 14X17 H5
LDR Spine Usa, Inc.
MC331P
In Commercial Distribution

  • 03662663021487 ()

  • Width: 17 Millimeter
  • Depth: 14 Millimeter
  • Height: 5 Millimeter


  • Polymeric spinal fusion cage, sterile
CLOSED CERVICAL CAGE 14X14 H5
LDR Spine Usa, Inc.
MC311P
In Commercial Distribution

  • 03662663021357 ()

  • Width: 14 Millimeter
  • Depth: 14 Millimeter
  • Height: 5 Millimeter


  • Polymeric spinal fusion cage, sterile
CERVICAL CAGE 12X15.5 H5 mm
LDR Spine Usa, Inc.
MC151P
In Commercial Distribution

  • 03662663021319 ()

  • Width: 15.5 Millimeter
  • Depth: 12 Millimeter
  • Height: 5 Millimeter


  • Polymeric spinal fusion cage, sterile
CERVICAL CAGE 14X15.5 H5 mm
LDR Spine Usa, Inc.
MC121P
In Commercial Distribution

  • 03662663021203 ()

  • Width: 15.5 Millimeter
  • Depth: 14 Millimeter
  • Height: 5 Millimeter


  • Polymeric spinal fusion cage, sterile
ROI-C lordosis implant 14x15.5 H5
LDR Spine Usa, Inc.
MC1421P
In Commercial Distribution

  • 03662663016407 ()

  • Width: 15.5 Millimeter
  • Depth: 14 Millimeter
  • Height: 5 Millimeter


  • Polymeric spinal fusion cage, sterile
ROI-C MONOBLOCK TRIAL 14X15.5 H5
LDR Spine Usa, Inc.
MC9032R
In Commercial Distribution

  • 03662663043441 ()

  • Height: 5 Millimeter
  • Width: 15.5 Millimeter
  • Depth: 14 Millimeter
MC9032R

  • Spinal implant trial
ROI-C MONOBLOCK TRIAL 14X14 H5
LDR Spine Usa, Inc.
MC9025R
In Commercial Distribution

  • 03662663043366 ()

  • Depth: 14 Millimeter
  • Width: 14 Millimeter
  • Height: 5 Millimeter
MC9025R

  • Spinal implant trial
ROI-C MONOBLOCK TRIAL 12X15.5 H5
LDR Spine Usa, Inc.
MC9018R
In Commercial Distribution

  • 03662663043281 ()

  • Height: 5 Millimeter
  • Width: 15.5 Millimeter
  • Depth: 12 Millimeter
MC9018R

  • Spinal implant trial
Laminar Hook - W7 x H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809263394695 ()

  • Width 7mm
  • Height: 5 Millimeter
FH.LH.0705

  • Bone-screw internal spinal fixation system, non-sterile
Laminar Hook - W5 x H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809263394664 ()

  • Width 5mm
  • Height: 5 Millimeter
FH.LH.0505

  • Bone-screw internal spinal fixation system, non-sterile
ROI-C COATED IMPLANT 12x15,5 H5
LDR Spine Usa, Inc.
CMC1351P
In Commercial Distribution

  • 03662663023313 ()

  • Height: 5 Millimeter
  • Depth: 12 Millimeter
  • Width: 15.5 Millimeter
CMC1351P

  • Metal-polymer composite spinal interbody fusion cage
ROI-C COATED IMPLANT 12x14 H5
LDR Spine Usa, Inc.
CMC1341P
In Commercial Distribution

  • 03662663023269 ()

  • Width: 14 Millimeter
  • Depth: 12 Millimeter
  • Height: 5 Millimeter
CMC1341P

  • Metal-polymer composite spinal interbody fusion cage
ROI-C COATED IMPLANT 14x17 H5
LDR Spine Usa, Inc.
CMC1331P
In Commercial Distribution

  • 03662663023214 ()

  • Height: 5 Millimeter
  • Depth: 14 Millimeter
  • Width: 17 Millimeter
CMC1331P

  • Metal-polymer composite spinal interbody fusion cage
ROI-C COATED IMPLANT 14x15,5 H5
LDR Spine Usa, Inc.
CMC1321P
In Commercial Distribution

  • 03662663023177 ()

  • Height: 5 Millimeter
  • Depth: 14 Millimeter
  • Width: 15.5 Millimeter
CMC1321P

  • Metal-polymer composite spinal interbody fusion cage
ROI-C COATED IMPLANT 14x14 H5
LDR Spine Usa, Inc.
CMC1311P
In Commercial Distribution

  • 03662663023122 ()

  • Width: 14 Millimeter
  • Depth: 14 Millimeter
  • Height: 5 Millimeter
CMC1311P

  • Metal-polymer composite spinal interbody fusion cage
Vision testing application - iOS version
Brightinsight, Inc.
1
In Commercial Distribution

  • 00860003376157 ()


  • Vision self-testing software
PHILIPS HEARLINK 2 1.5.0 IOS
Sbo Hearing A/S
274917
In Commercial Distribution

  • 05714464146086 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2 1.4.0 IOS
Sbo Hearing A/S
270492
In Commercial Distribution

  • 05714464139460 ()


  • Hearing aid/implant system remote control
BERNAFON EASYCONTROL CONNECT 3.1.0 IOS
Sbo Hearing A/S
215182
In Commercial Distribution

  • 05714464004584 ()


  • Hearing aid/implant system remote control
Bernafon EasyControl Connect 3.3.0 iOS
Sbo Hearing A/S
228215
In Commercial Distribution

  • 05714464012992 ()


  • Hearing aid/implant system remote control
Sonic SoundLink Connect 3.3.0 iOS
Sbo Hearing A/S
228213
In Commercial Distribution

  • 05714464012978 ()


  • Hearing aid/implant system remote control
Philips HearLink Connect 3.3.0 iOS
Sbo Hearing A/S
228211
In Commercial Distribution

  • 05714464012954 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK CONNECT 3.1.0 IOS
Sbo Hearing A/S
215186
In Commercial Distribution

  • 05714464004621 ()


  • Hearing aid/implant system remote control
SONIC SOUNDLINK CONNECT 3.1.0 IOS
Sbo Hearing A/S
215184
In Commercial Distribution

  • 05714464004607 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK CONNECT 3.5.0 IOS
Sbo Hearing A/S
246112
In Commercial Distribution

  • 05714464059782 ()


  • Hearing aid/implant system remote control
SONIC SOUNDLINK CONNECT 3.5.0 IOS
Sbo Hearing A/S
246110
In Commercial Distribution

  • 05714464059768 ()


  • Hearing aid/implant system remote control
BERNAFON EASYCONTROL CONNECT 3.5.0 IOS
Sbo Hearing A/S
246108
In Commercial Distribution

  • 05714464059744 ()


  • Hearing aid/implant system remote control
Philips HearLink 2 1.0.0 iOS
Sbo Hearing A/S
242488
In Commercial Distribution

  • 05714464058990 ()


  • Hearing aid/implant system remote control
Kosmos OTS iOS Software Package
ECHONOUS, INC.
P007639
In Commercial Distribution

  • 09353278000717 ()


  • Ultrasound imaging system application software
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.
2.7
In Commercial Distribution

  • 00606959046818 ()
1128264

  • Self-care monitoring/reporting software
IOS VMAX SERIES OPTION-ICU CART
VYAIRE MEDICAL, INC.
776268-103
In Commercial Distribution

  • 10190752164154 ()
776268-103

  • Neonatal/adult intensive-care ventilator
PHILIPS HEARLINK 2 1.2.0 IOS
Sbo Hearing A/S
265706
In Commercial Distribution

  • 05714464127153 ()


  • Hearing aid/implant system remote control
PHILIPS HEARLINK 2 1.1.0 IOS
Sbo Hearing A/S
264788
In Commercial Distribution

  • 05714464125227 ()


  • Hearing aid/implant system remote control
SW M01A02 CARELINK SMARTSYNC IOS
MEDTRONIC, INC.
M01A02
In Commercial Distribution

  • 00643169833739 ()


  • Implantable cardiac device management application software
PHILIPS HEARLINK 2 1.3.0 IOS
Sbo Hearing A/S
269358
In Commercial Distribution

  • 05714464133987 ()


  • Hearing aid/implant system remote control
SONIC SOUNDLINK 3 1.2.0 IOS
Sbo Hearing A/S
265708
In Commercial Distribution

  • 05714464127177 ()


  • Hearing aid/implant system remote control
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