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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Mecta-C SA – Plate Trio Lock h5
Medacta International SA
03.18.305
In Commercial Distribution

  • 07630040725934 ()


  • Metallic spinal interbody fusion cage
TRIAL L12 x W14 x H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809489298951 ()
AC.2017

  • Bone-screw internal spinal fixation system, non-sterile
TRIAL L14 x W16 x H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809489298944 ()
AC.2033

  • Bone-screw internal spinal fixation system, non-sterile
ROI-C LORDOTIC COATED IMPLANT 12x15,5 H5
LDR Spine Usa, Inc.
CMC1451P
In Commercial Distribution

  • 03662663023597 ()

  • Width: 15.5 Millimeter
  • Depth: 12 Millimeter
  • Height: 5 Millimeter
CMC1451P

  • Metal-polymer composite spinal interbody fusion cage
ROI-C LORDOTIC COATED IMPLANT 12x14 H5
LDR Spine Usa, Inc.
CMC1441P
In Commercial Distribution

  • 03662663023535 ()

  • Width: 14 Millimeter
  • Depth: 12 Millimeter
  • Height: 5 Millimeter
CMC1441P

  • Metal-polymer composite spinal interbody fusion cage
ROI-C LORDOTIC COATED IMPLANT 14x17 H5
LDR Spine Usa, Inc.
CMC1431P
In Commercial Distribution

  • 03662663023474 ()

  • Height: 5 Millimeter
  • Depth: 14 Millimeter
  • Width: 17 Millimeter
CMC1431P

  • Metal-polymer composite spinal interbody fusion cage
ROI-C LORDOTIC COATED IMPLANT 14x15,5 H5
LDR Spine Usa, Inc.
CMC1421P
In Commercial Distribution

  • 03662663023412 ()

  • Height: 5 Millimeter
  • Depth: 14 Millimeter
  • Width: 15.5 Millimeter
CMC1421P

  • Metal-polymer composite spinal interbody fusion cage
ROI-C LORDOTIC COATED IMPLANT 14x14 H5
LDR Spine Usa, Inc.
CMC1411P
In Commercial Distribution

  • 03662663023351 ()

  • Height: 5 Millimeter
  • Depth: 14 Millimeter
  • Width: 14 Millimeter
CMC1411P

  • Metal-polymer composite spinal interbody fusion cage
ACIF Trial, MD, Lordotic, H5/H6mm
CTL Medical Corporation
113.7335
In Commercial Distribution

  • 00841732165816 ()


  • Spinal implant trial
ACIF Trial, SM, Lordotic, H5/H6mm
CTL Medical Corporation
113.7315
In Commercial Distribution

  • 00841732165786 ()


  • Spinal implant trial
Actual downloadable APP, called Omnipod 5 Controller APP
Insulet Corporation
1.0
In Commercial Distribution

  • 10385081120302 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
SW APP A620 DBS PATIENT APP V3.0 LK55
MEDTRONIC, INC.
A620
In Commercial Distribution

  • 00763000523329 ()


  • Multiple active implantable device programmer
SW APP A610 DBS CLINICIAN APP V4.0 LK54
MEDTRONIC, INC.
A610
In Commercial Distribution

  • 00763000523312 ()


  • Multiple active implantable device programmer
DreamMapper Mobile iOS China Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059801 ()
1136968

  • Self-care monitoring/reporting software
DreamMapper Mobile iOS APAC Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059795 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper Mobile iOS EU Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059788 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper Mobile iOS NA Instance v2.24
Respironics, Inc.
2.24
In Commercial Distribution

  • 00606959059771 ()
1101478

  • Self-care monitoring/reporting software
DreamMapper iOS APAC Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959059061 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper iOS EU Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959059054 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper iOS NA Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959059047 ()
1101478

  • Self-care monitoring/reporting software
DreamMapper iOS APAC Instance v 2.20
Respironics, Inc.
2.20
In Commercial Distribution

  • 00606959057203 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper iOS EU Instance v 2.20
Respironics, Inc.
2.20
In Commercial Distribution

  • 00606959057197 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper iOS NA Instance v 2.20
Respironics, Inc.
2.20
In Commercial Distribution

  • 00606959057180 ()
1101478

  • Self-care monitoring/reporting software
DreamMapper iOS China Instance v 2.23
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959059078 ()
1136968

  • Self-care monitoring/reporting software
DreamMapper iOS China Instance v 2.20
Respironics, Inc.
2.20
In Commercial Distribution

  • 00606959057210 ()
1136968

  • Self-care monitoring/reporting software
DreamMapper iOS, China Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054295 ()
1136968

  • Self-care monitoring/reporting software
DreamMapper iOS China Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution

  • 00606959051362 ()
1136968

  • Self-care monitoring/reporting software
DreamMapper iOS China Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution

  • 00606959049963 ()
1136968

  • Self-care monitoring/reporting software
Hearing Test Feature iOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949149948 ()


  • Self-testing tone audiometer
Hearing Aid Feature iOS (1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949149924 ()


  • Air-conduction hearing aid, in-the-ear
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