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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SCALER HYGIENIST H5/33 DE #2H
DARBY DENTAL SUPPLY, LLC
5257285
In Commercial Distribution

  • 00889813066348 ()


  • Manual dental scaler, reusable
UniPost abutment Ø6.5mm H5 mm indexed
BIOTECH DENTAL
KPV655
In Commercial Distribution

  • 03701045238140 ()


  • Dental implant system
UniPost abutment Ø4.0mm H5 mm indexed
BIOTECH DENTAL
KPV405
In Commercial Distribution

  • 03701045238058 ()


  • Dental implant system
Double Ended Trials L12xW16XA7 H5 & 6
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039870528 ()
CSA.0166

  • Spinal fixation plate, non-bioabsorbable
Straight abutment H5 Internal Hex RP
UNIQA DENTAL LTD
USBR-4605
In Commercial Distribution

  • 07290112858788 ()
USBR-4605

  • Dental implant suprastructure, permanent, preformed
Laminar Hook - W7 x H5 .F
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809263394909 ()

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

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

  • 08809263394879 ()

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

  • Bone-screw internal spinal fixation system, non-sterile
Mecta-C SA – Plate Quattro Lag h5
Medacta International SA
03.18.415
In Commercial Distribution

  • 07630040726177 ()


  • Metallic spinal interbody fusion cage
Mecta-C SA – Plate Trio Lag h5
Medacta International SA
03.18.315
In Commercial Distribution

  • 07630040726016 ()


  • Metallic spinal interbody fusion cage
Mecta-C SA – Plate Quattro Lock h5
Medacta International SA
03.18.405
In Commercial Distribution

  • 07630040726092 ()


  • Metallic spinal interbody fusion cage
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
Athena GTX Device Management Suite - iOS
ATHENA GTX, INC.
ADMS iOS Software
In Commercial Distribution

  • B3943950009000 ()
395-0009-00

  • Centralized patient monitor
OB Legacy System iOS Software System
Airstrip Technologies, Inc.
1001
In Commercial Distribution

  • B15310010 ()


  • Bedside monitor remote-viewing software, physiological parameter
SFTWR MMT-6112 CP IOS V2.2.0 OUS
MEDTRONIC MINIMED, INC.
MMT-6112
In Commercial Distribution

  • 00763000432645 ()


  • Patient health record information system application software
Sftwr MMT-6112 CP iOS 3.3.1 US
MEDTRONIC MINIMED, INC.
MMT-6112
In Commercial Distribution

  • 00763000827304 ()


  • Patient health record information system application software
SFTWR MMT-6112 CP IOS V2.3.0 US
MEDTRONIC MINIMED, INC.
MMT-6112
In Commercial Distribution

  • 00763000437787 ()


  • Patient health record information system application software
Hearing Implant Software for iOS Devices
COCHLEAR LIMITED
P1861019
In Commercial Distribution

  • 09321502065764 ()
P2006651

  • Audiometric/hearing device software
Onduo App Android
VERILY LIFE SCIENCES LLC
SW0004
In Commercial Distribution

  • 00860000249539 ()


  • Self-care monitoring/reporting software
APP HEAR.COM HORIZON
Ws Audiology Usa, Inc.
hear.com horizon
In Commercial Distribution

  • 05714880113228 ()
10996569

  • Hearing aid/implant system remote control
APP CONNEXX FIT2GO
Ws Audiology Usa, Inc.
Connexx Fit2Go
In Commercial Distribution

  • 05714880187229 ()
21023158

  • Audiometric/hearing device software
Viewfinder remote app
Edwards Lifesciences LLC
VFREM
In Commercial Distribution

  • 00690103215847 ()
VFREM

  • Bedside monitor remote-viewing software, physiological parameter
  • General-purpose multi-parameter bedside monitor
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