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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M10345 - Salmonella Monovalent H Antiserum - Factor H-5 - 2ml
MAST GROUP LIMITED
M10345
In Commercial Distribution

  • 15060392375881 ()
M10345

  • Multiple Salmonella species culture isolate antigen IVD, kit, agglutination
SCALER # H5/33 (ONYX COLLECTION) (US ALLOY N664)
POMEE CORPORATION
711-533OC
In Commercial Distribution

  • G157711533OC0 ()
711-533OC

  • Manual dental scaler, reusable
SV1/H56 SAVANNAH 1/H5 #6 HDL 1P
Peter Brasseler Holdings, LLC
5023453U0
In Commercial Distribution

  • 00887919682509 ()


  • Manual dental scaler, reusable
SH5/H5S6 H5/H5S SCAL #6 HDL 1P
Peter Brasseler Holdings, LLC
5023410U0
In Commercial Distribution

  • 00887919682073 ()


  • Manual dental scaler, reusable
SH5/486 H5/48 SCAL #6 HDL 1P
Peter Brasseler Holdings, LLC
5023408U0
In Commercial Distribution

  • 00887919682059 ()


  • Manual dental scaler, reusable
SH5/336 H5/33 SCAL #6 HDL 1P
Peter Brasseler Holdings, LLC
5023406U0
In Commercial Distribution

  • 00887919682035 ()


  • Manual dental scaler, reusable
SH5/U156 H5/U15 SCAL #6 HDL 1P
Peter Brasseler Holdings, LLC
5023411U0
In Commercial Distribution

  • 00887919682080 ()


  • Manual dental scaler, reusable
Galaxy ACIF cage H5 x W16 x L14
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809263396101 ()

  • Height: 5 Millimeter
  • Width 16mm, Length 14mm
NC551614

  • Bone-screw internal spinal fixation system, non-sterile
Galaxy ACIF cage H5 x W15 x L14
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809263396057 ()

  • Width 15mm, Length 14mm
  • Height: 5 Millimeter
NC551514

  • Bone-screw internal spinal fixation system, non-sterile
Galaxy ACIF cage H5 x W14 x L12
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809263396002 ()

  • Height: 5 Millimeter
  • Width 14mm, Length 12mm
NC551412

  • Bone-screw internal spinal fixation system, non-sterile
TRIAL L12 x W14 x A7 x H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809489299392 ()
AC.2025

  • Bone-screw internal spinal fixation system, non-sterile
TRIAL L14 x W16 x A7 x H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809489299149 ()
AC.2041

  • Bone-screw internal spinal fixation system, non-sterile
ACIF Depth Stop Trial, MD, 12°, H5/H6mm
CTL Medical Corporation
113.7475
In Commercial Distribution

  • 00841732165168 ()


  • Metallic spinal interbody fusion cage
ACIF Depth Stop Trial, SM, 12°, H5/H6mm
CTL Medical Corporation
113.7465
In Commercial Distribution

  • 00841732165137 ()


  • Metallic spinal interbody fusion cage
ACIF Depth Stop Trial, SM, Lordotic, H5/H6mm
CTL Medical Corporation
113.7415
In Commercial Distribution

  • 00841732129115 ()


  • Spinal implant trial
ACIF Depth Stop Trial, MD, Parallel, H5/H6
CTL Medical Corporation
113.7425
In Commercial Distribution

  • 00841732125483 ()


  • Spinal implant trial
ACIF Depth Stop Trial, SM, Parallel, H5/H6mm
CTL Medical Corporation
113.7405
In Commercial Distribution

  • 00841732125452 ()


  • Spinal implant trial
Sirona B Android App
DATRIX LLC
RX22711
In Commercial Distribution

  • 00851074007149 ()


  • Telemetric electrocardiographic ambulatory recorder
Sirona B PC App
DATRIX LLC
RX22673
In Commercial Distribution

  • 00851074007125 ()


  • Telemetric electrocardiographic ambulatory recorder
TempTraq Clinician Android App
BLUE SPARK TECHNOLOGIES, INC.
4.x.x
In Commercial Distribution

  • 00851203006432 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Clinician Web App
BLUE SPARK TECHNOLOGIES, INC.
4.x.x
In Commercial Distribution

  • 00851203006388 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Patient Android App
BLUE SPARK TECHNOLOGIES, INC.
4.x.x
In Commercial Distribution

  • 00851203006364 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Clinician Web App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Clinician Web App
Not in Commercial Distribution

  • 00851203006173 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Clinician Android App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Clinician Android App
Not in Commercial Distribution

  • 00851203006128 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Patient Android App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Patient Android App
Not in Commercial Distribution

  • 00851203006111 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
TempTraq Consumer Android App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Consumer Android App
Not in Commercial Distribution

  • 00851203006036 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
Widex MOMENT App Android
Widex A/S
Moment app
In Commercial Distribution

  • 05706069930320 ()
5 300 0022 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
Beyond App Android 1.2
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069689112 ()
5 300 0009 001

  • Hearing aid/implant system remote control
Widex ToneLink App Android
Widex A/S
ToneLink app
In Commercial Distribution

  • 05706069702965 ()
5 300 0017 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
ON APP 1.2 ANDROID
Oticon A/S
176635
In Commercial Distribution

  • 05707131328526 ()


  • Hearing aid/implant system remote control
Sony | Hearing Control App
Ws Audiology Usa, Inc.
Sony | Hearing Control
In Commercial Distribution

  • 05714880189308 ()
21022296

  • Audiometric/hearing device software
Bionic Circle App, Android
Beta Bionics, Inc.
BOM000083
In Commercial Distribution

  • 00850050080176 ()
BB5002

  • Ambulatory insulin infusion pump software, data-display
BERNAFON APP 1.5.0 ANDROID
Sbo Hearing A/S
274910
In Commercial Distribution

  • 05714464146017 ()


  • Hearing aid/implant system remote control
Bernafon App 1.0.0 Android
Sbo Hearing A/S
242481
In Commercial Distribution

  • 05714464058921 ()


  • Hearing aid/implant system remote control
BERNAFON APP 1.3.0 ANDROID
Sbo Hearing A/S
269351
In Commercial Distribution

  • 05714464133918 ()


  • Hearing aid/implant system remote control
BERNAFON APP 1.2.0 ANDROID
Sbo Hearing A/S
265713
In Commercial Distribution

  • 05714464127221 ()


  • Hearing aid/implant system remote control
BERNAFON APP 1.1.0 ANDROID
Sbo Hearing A/S
264781
In Commercial Distribution

  • 05714464125159 ()


  • Hearing aid/implant system remote control
BERNAFON APP 1.4.0 ANDROID
Sbo Hearing A/S
270494
In Commercial Distribution

  • 05714464139484 ()


  • Hearing aid/implant system remote control
OvuSense 2 App - Android
VIO HEALTHTECH LIMITED
M032 Android
In Commercial Distribution

  • 05060508530114 ()


  • Thermometric fertility analyser
Vea - Mobile Alignment App
ALPHATEC SPINE, INC.
AIX21000
In Commercial Distribution

  • 00190376470351 ()


  • Orthopaedic/craniofacial implantation planning software
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