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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myPhonak 4.0 app
Sonova AG
088-0013-70
In Commercial Distribution

  • 07613389399295 ()
088-0013-70

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-24
In Commercial Distribution

  • 07613389399288 ()
088-0013-24

  • Audiometric/hearing device software
myPhonak 4.0 app
Sonova AG
088-0013-21
In Commercial Distribution

  • 07613389399271 ()
088-0013-21

  • Audiometric/hearing device software
SCS Programming App
NALU MEDICAL, INC.
53001
In Commercial Distribution

  • 00812537030463 ()
53001

  • Implantable electrical stimulation device management software
SmartView Connect App
MICROPORT CRM SRL
SW001U
In Commercial Distribution

  • 08031527019932 ()
SW001U

  • Cardiology information system application software
myPhonak Junior app
Sonova AG
088-0017
In Commercial Distribution

  • 07613389477283 ()
088-0017

  • Audiometric/hearing device software
myPhonak Junior app
Sonova AG
088-0017-83
In Commercial Distribution

  • 07613389477184 ()
088-0017-83

  • Audiometric/hearing device software
myPhonak Junior app
Sonova AG
088-0017-09
In Commercial Distribution

  • 07613389477160 ()
088-0017-09

  • Audiometric/hearing device software
myPhonak Junior app
Sonova AG
088-0017-14
In Commercial Distribution

  • 07613389477146 ()
088-0017-14

  • Audiometric/hearing device software
myPhonak Junior app
Sonova AG
088-0017-26
In Commercial Distribution

  • 07613389477122 ()
088-0017-26

  • Audiometric/hearing device software
myPhonak Junior app
Sonova AG
088-0017-12
In Commercial Distribution

  • 07613389477108 ()
088-0017-12

  • Audiometric/hearing device software
myPhonak Junior app
Sonova AG
088-0017-17
In Commercial Distribution

  • 07613389477054 ()
088-0017-17

  • Audiometric/hearing device software
myPhonak Junior app
Sonova AG
088-0017-97
In Commercial Distribution

  • 07613389477030 ()
088-0017-97

  • Audiometric/hearing device software
myPhonak Junior app
Sonova AG
088-0017-13
In Commercial Distribution

  • 07613389477016 ()
088-0017-13

  • Audiometric/hearing device software
myPhonak Junior app
Sonova AG
088-0017-20
In Commercial Distribution

  • 07613389476996 ()
088-0017-20

  • Audiometric/hearing device software
myPhonak Junior app
Sonova AG
088-0017-04
In Commercial Distribution

  • 07613389476972 ()
088-0017-04

  • Audiometric/hearing device software
myPhonak Junior app
Sonova AG
088-0017-02
In Commercial Distribution

  • 07613389476958 ()
088-0017-02

  • Audiometric/hearing device software
myPhonak Junior app
Sonova AG
088-0017-08
In Commercial Distribution

  • 07613389476934 ()
088-0017-08

  • Audiometric/hearing device software
myPhonak Junior app
Sonova AG
088-0017-15
In Commercial Distribution

  • 07613389476910 ()
088-0017-15

  • Audiometric/hearing device software
myPhonak Junior app
Sonova AG
088-0017-44
In Commercial Distribution

  • 07613389475203 ()
088-0017-44

  • Audiometric/hearing device software
myPhonak Junior app
Sonova AG
088-0017-24
In Commercial Distribution

  • 07613389475180 ()
088-0017-24

  • Audiometric/hearing device software
HelloGo Hearing App
Unitron Hearing Division
088-5012
In Commercial Distribution

  • 07613389444391 ()
088-5012

  • Audiometric/hearing device software
myPhonak 5.0 app
Sonova AG
088-0014
In Commercial Distribution

  • 07613389430639 ()
088-0014

  • Audiometric/hearing device software
myPhonak 5.0 app
Sonova AG
088-0014-83
In Commercial Distribution

  • 07613389430615 ()
088-0014-83

  • Audiometric/hearing device software
myPhonak 5.0 app
Sonova AG
088-0014-22
In Commercial Distribution

  • 07613389430608 ()
088-0014-22

  • Audiometric/hearing device software
myPhonak 5.0 app
Sonova AG
088-0014-09
In Commercial Distribution

  • 07613389430592 ()
088-0014-09

  • Audiometric/hearing device software
myPhonak 5.0 app
Sonova AG
088-0014-14
In Commercial Distribution

  • 07613389430578 ()
088-0014-14

  • Audiometric/hearing device software
myPhonak 5.0 app
Sonova AG
088-0014-28
In Commercial Distribution

  • 07613389430547 ()
088-0014-28

  • Audiometric/hearing device software
myPhonak 5.0 app
Sonova AG
088-0014-16
In Commercial Distribution

  • 07613389430523 ()
088-0014-16

  • Audiometric/hearing device software
G7 Android App
Dexcom, Inc.
SW12299
In Commercial Distribution

  • 00386270001870 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
JBAIDS IVD Influenza A/H5 Detection Kit
BIOFIRE DEFENSE, LLC
JRPD-ASY-0136
Not in Commercial Distribution

  • 00851458005082 ()
JRPD-ASY-0136

  • Influenza A virus H5N1 subtype (avian influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)
AEON-C Stand Alone; TAV; 15x18; 15deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039836487 ()
CSAT.15181505

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; TAV; 15x18; 7deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039836371 ()
CSAT.15180705

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; TAV; 15x18; 0deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039836265 ()
CSAT.15180005

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; TAV; 14x16; 15deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039836159 ()
CSAT.14161505

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; TAV; 14x16; 7deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039836043 ()
CSAT.14160705

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; TAV; 14x16; 0deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835930 ()
CSAT.14160005

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; TAV; 12x14; 15deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835824 ()
CSAT.12141505

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; TAV; 12x14; 7deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835718 ()
CSAT.12140705

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; TAV; 12x14; 0deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835602 ()
CSAT.12140005

  • Spinal fixation plate, non-bioabsorbable
MOBI-C IMPLANT M « STANDARD » 19x19 H5 US
LDR Spine Usa, Inc.
MB3995
In Commercial Distribution

  • 03662663002073 ()

  • Width: 19 Millimeter
  • Depth: 19 Millimeter
  • Height: 5 Millimeter
MB3995

  • Cervical total intervertebral disc prosthesis, modular
MOBI-C IMPLANT M « STANDARD » 17x19 H5 US
LDR Spine Usa, Inc.
MB3795
In Commercial Distribution

  • 03662663002042 ()

  • Height: 5 Millimeter
  • Depth: 17 Millimeter
  • Width: 19 Millimeter
MB3795

  • Cervical total intervertebral disc prosthesis, modular
MOBI-C IMPLANT M « STANDARD » 17x17 H5 US
LDR Spine Usa, Inc.
MB3775
In Commercial Distribution

  • 03662663002011 ()

  • Width: 17 Millimeter
  • Depth: 17 Millimeter
  • Height: 5 Millimeter
MB3775

  • Cervical total intervertebral disc prosthesis, modular
ROI-C Lordotic Rounded Tooth Trial 12x14 H5
LDR Spine Usa, Inc.
SI-ROIC-0116
In Commercial Distribution

  • 03662663047432 ()

  • Height: 5 Millimeter
  • Width: 14 Millimeter
  • Depth: 12 Millimeter
SI-ROIC-0116

  • Spinal implant trial
JACQUETTE SCLR RND HD DE H5/33
SKLAR CORPORATION
49-2750
In Commercial Distribution

  • 10649111103247 ()


  • Manual dental scaler, reusable
#H5/33 DE Scaler, AD Style, ResinEight
HU-FRIEDY MFG. CO., LLC
SH5/338Z
Not in Commercial Distribution

  • 10889950095871 ()


  • Manual dental scaler, reusable
#204 SICKLE-RIGHT/#H5 DE SCALER, #6 Hdl
HU-FRIEDY MFG. CO., LLC
SC5179
In Commercial Distribution

  • 10889950092818 ()


  • Manual dental scaler, reusable
904 Band Pusher/H5 Sickle, #41 Handle
HU-FRIEDY MFG. CO., LLC
PI7011
In Commercial Distribution

  • 10889950083373 ()


  • Orthodontic metal band pusher
#H5/NEVI #1 SICKLE SCALER DE, ResinEight
HU-FRIEDY MFG. CO., LLC
SNEV1/H58
In Commercial Distribution

  • 10889950030568 ()


  • Manual dental scaler, reusable
#H5/NEVI #1 SICKLE Scaler DE, SS
HU-FRIEDY MFG. CO., LLC
SNEV1/H56
In Commercial Distribution

  • 10889950030544 ()


  • Manual dental scaler, reusable
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