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 Class Implantable

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No Description
HELENA LABORATORIES CORPORATION
5102
In Commercial Distribution

  • M52551020 ()


  • Alkaline phosphatase (ALP) isoenzyme IVD, reagent
No Description
HELENA LABORATORIES CORPORATION
3348
In Commercial Distribution

  • M52533480 ()


  • Alkaline phosphatase (ALP) isoenzyme IVD, reagent
No Description
HELENA LABORATORIES CORPORATION
3058
In Commercial Distribution

  • M52530580 ()


  • Alkaline phosphatase (ALP) isoenzyme IVD, reagent
MicroVue BAP EIA
QUIDEL CORPORATION
BAP EIA
In Commercial Distribution

  • 30014613333920 ()
8012

  • Bone alkaline phosphatase (BALP) IVD, kit, enzyme immunoassay (EIA)
The Access Ostase assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay Systems for the quantitative measurement of bone alkaline phosphatase (BAP), and indicator of osteoblastic activity in human serum and plasma. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease.
Beckman Coulter, Inc.
37300
In Commercial Distribution

  • 15099590232313 ()
37300

  • Bone alkaline phosphatase (BALP) IVD, kit, chemiluminescent immunoassay
No Description
Ventana Medical Systems, Inc.
06680011001
In Commercial Distribution

  • 04015630970476 ()
06680011001

  • p16 antigen IVD, antibody
No Description
Ventana Medical Systems, Inc.
50 Tests
In Commercial Distribution

  • 04015630970452 ()
06680003001

  • p16 antigen IVD, antibody
for Android
COCHLEAR LIMITED
NSA-2 / v5
In Commercial Distribution

  • 09321502062190 ()
P1834165

  • Audiometric/hearing device software
for Android
COCHLEAR LIMITED
NSA-2 / v4
In Commercial Distribution

  • 09321502060479 ()
P1787373

  • Audiometric/hearing device software
G6 Android
Dexcom, Inc.
SW11678
In Commercial Distribution

  • 00386270000811 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Android 5.0
Philips Ultrasound LLC
795005
In Commercial Distribution

  • 00884838122116 ()


  • General-purpose ultrasound imaging system
Android App
INTRICON CORPORATION
HHE Hearing
In Commercial Distribution

  • 00858177007335 ()
23354

  • Audiometric/hearing device software
Android App
INTRICON CORPORATION
hiHearing
In Commercial Distribution

  • 00858177007144 ()
22958

  • Audiometric/hearing device software
myAir (Android)
RESMED CORP.
22246
In Commercial Distribution

  • 00840193400122 ()
22246

  • Self-care monitoring/reporting software
RMDpulse (Android)
RESMED CORP.
22254
In Commercial Distribution

  • 00840193400023 ()


  • Ventilator application software
KIT,SUCTION,ORAL, PINT SIZE,12HR,CIN
MEDLINE INDUSTRIES, INC.
MDS876712CC
In Commercial Distribution

  • 20888277681610 ()
  • 10888277681613 ()
MDS876712CC

  • Oral care kit, single-use
Neurofeedback Software Application for Android
EXSURGO LIMITED
Android
In Commercial Distribution

  • 09413000078510 ()
100321

  • Psychophysiological biofeedback system
Clue is a digital smartphone application helping people with cycles better understand their menstrual and reproductive health. There are three different modes for users to pick from, depending on what suits their current goal best Clue Period Tracking, Clue Conceive, and Clue Pregnancy. Across all modes there are different features that allow users to track their health experiences, access current scientific literature, and learn more about what’s happening to their body. Both a free version and a paid premium version of the app, called Clue Plus, are available to users. Clue Conceive is a mode of the Clue app. Clue Conceive's proprietary algorithm uses period start date information entered by the user to provide predictions on the best days to try and conceive.
BioWink GmbH
Android
In Commercial Distribution

  • 04260749840046 ()


  • Self-care monitoring/reporting software
Clue Conceive is a mode of the Clue app. Clue Conceive's proprietary algorithm uses period start date information entered by the user to provide predictions on the best days to try and conceive. Identification of high chance days allows the user to determine the days on which their chance of conception is highest, and then make choices about when to have sex to increase chance of pregnancy.
BioWink GmbH
Android
In Commercial Distribution

  • 04260749840022 ()


  • Self-care monitoring/reporting software
Yersinia Sel (CIN)(deep,add R45050) 20/PK
REMEL, INC.
R09999
In Commercial Distribution

  • 00848838013782 ()
R09999

  • Differential/selective agar culture medium IVD
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