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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Mix2Vial™ 20/20mm w/15µm Large Filter TG
WEST PHARMA. SERVICES IL, . LTD
8074046
In Commercial Distribution

  • 27290108240997 ()
  • 17290108240990 ()
  • 07290108240993 ()


  • Medication transfer needle, filtering
Mobile version
3DIEMME SRL
RealGUIDE APP
In Commercial Distribution

  • 08050038830003 ()


  • CAD/CAM software
No Description
Pjama AB
DryGuardians App
In Commercial Distribution

  • 07350078445160 ()
4200

  • Incontinence sensor/alarm
No Description
Clarius Mobile Health Corp
App - Android
In Commercial Distribution

  • 07540205000403 ()
12-01-00004

  • Ultrasound imaging system application software
  • Radiological PACS software
No Description
Roche Diagnostics GmbH
05918081190
In Commercial Distribution

  • 07613336180877 ()
05918081190

  • Thyroglobulin IVD, control
Anti-TG Ab is an ELISA test system for the quantitative measurement of IgG class autoantibodies against thyroglobulin (TG) in human serum or plasma.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3708
In Commercial Distribution

  • 04048474037081 ()
EIA-3708

  • Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA)
Anti-TG Ab is an ELISA test system for the quantitative measurement of IgG class autoantibodies against thyroglobulin (TG) in human serum or plasma.
DRG International Inc
EIA-3708
In Commercial Distribution

  • 00840239037084 ()
EIA-3708

  • Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Sugarmate, LLC
1007228
In Commercial Distribution

  • 00850018992435 ()


  • Self-care monitoring/reporting software
Clinical decision support software indicated for use by licensed clinicians to inform the detection of disease utilizing an iOS client.
AMBIENT CLINICAL ANALYTICS, INC.
1.0
In Commercial Distribution

  • 00850893007033 ()


  • Clinical management support software
No Description
Philips Ultrasound LLC
795161
In Commercial Distribution

  • 00884838103405 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
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