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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CUSTOM PACK 7S49R2 4PK VAC APK
MEDTRONIC, INC.
7S49R2
In Commercial Distribution

  • 20643169613366 ()
  • 00643169613355 ()


  • Cardiopulmonary bypass system blood tubing set
Cin/Femoral Impactor - Assembly
Medacta International SA
02.02.10.0839
In Commercial Distribution

  • 07630040777834 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Yersenia Selective (CIN) Agar
Northeast Laboratory Services, Inc.
1
In Commercial Distribution

  • 00810144910185 ()
P1160

  • Differential/selective agar culture medium IVD
VR-CI series, VacReg, Cont Int 300mmHg, Analog (inHg)
OHIO MEDICAL, LLC
CIN
In Commercial Distribution

  • 00628101501068 ()


  • Vacuum suction regulator/regulation set, general-purpose
Android
RESMED PTY LTD
22244
In Commercial Distribution

  • 00619498222445 ()


  • Ventilator application software
NEURO SPINE UNIV OF CIN PK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0411267N
In Commercial Distribution

  • 40193489423199 ()
  • 10193489423198 ()
DYNJ0411267N

  • General surgical procedure kit, non-medicated, single-use
NEURO CRANI UNIV OF CIN PK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0411273N
In Commercial Distribution

  • 10193489502350 ()
DYNJ0411273N

  • General surgical procedure kit, non-medicated, single-use
NEURO SPINE UNIV OF CIN PK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0411267M
In Commercial Distribution

  • 10193489502046 ()
  • 40193489502047 ()
DYNJ0411267M

  • General surgical procedure kit, non-medicated, single-use
Yersinia Sel (CIN) Agar 10/PK
REMEL, INC.
R01998
In Commercial Distribution

  • 00848838003585 ()
R01998

  • Differential/selective agar culture medium IVD
NEURO CRANI UNIV OF CIN PK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0411273O
In Commercial Distribution

  • 40193489372879 ()
  • 10193489372878 ()
DYNJ0411273O

  • General surgical procedure kit, non-medicated, single-use
NEURO CRANI UNIV OF CIN PK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0411273M
In Commercial Distribution

  • 10889942878826 ()
  • 40889942878827 ()
DYNJ0411273M

  • General surgical procedure kit, non-medicated, single-use
NEURO SPINE UNIV OF CIN PK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0411267L
In Commercial Distribution

  • 10889942878819 ()
DYNJ0411267L

  • General surgical procedure kit, non-medicated, single-use
NEURO CRANI UNIV OF CIN PK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0411273P
In Commercial Distribution

  • 40198459131449 ()
  • 10198459131448 ()
DYNJ0411273P

  • General surgical procedure kit, non-medicated, single-use
No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
IS-2800US
In Commercial Distribution

  • 05060169695801 ()


  • Bone alkaline phosphatase (BALP) IVD, kit, chemiluminescent immunoassay
No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
AC-20F1
In Commercial Distribution

  • 05060169690059 ()


  • Bone alkaline phosphatase (BALP) IVD, kit, chemiluminescent immunoassay
UniQ® PINP RIA is a quantitative radioimmunoassay designed for the measurement of the concentration of intact aminoterminal propeptide of type I procollagen, an indicator of osteoblastic activity, in human serum.
Aidian Oy
67034
In Commercial Distribution

  • 06438115000082 ()
67034

  • Procollagen type I N-terminal propeptide (PINP) IVD, kit, radioimmunoassay
No Description
HELENA LABORATORIES CORPORATION
552604
In Commercial Distribution

  • M5255526040 ()


  • Alkaline phosphatase (ALP) isoenzyme IVD, reagent
No Description
HELENA LABORATORIES CORPORATION
552395
In Commercial Distribution

  • M5255523950 ()


  • Alkaline phosphatase (ALP) isoenzyme IVD, reagent
No Description
HELENA LABORATORIES CORPORATION
552055
In Commercial Distribution

  • M5255520550 ()


  • Alkaline phosphatase (ALP) isoenzyme IVD, reagent
No Description
HELENA LABORATORIES CORPORATION
551031
In Commercial Distribution

  • M5255510310 ()


  • Alkaline phosphatase (ALP) isoenzyme IVD, reagent
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
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
Android 5.0
Philips Ultrasound LLC
795005
In Commercial Distribution

  • 00884838122116 ()


  • General-purpose ultrasound imaging system
G6 Android
Dexcom, Inc.
SW11678
In Commercial Distribution

  • 00386270000811 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
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
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
EASYCONTROL-A 2.1.0 ANDROID
Bernafon AG
214718
In Commercial Distribution

  • 05711584115886 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 2.0 ANDROID
Bernafon AG
204544
In Commercial Distribution

  • 05711584106587 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 1.10 ANDROID
Bernafon AG
199522
In Commercial Distribution

  • 05711584095508 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 1.9 ANDROID
Oticon A/S
189255
In Commercial Distribution

  • 05711584085349 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 1.8 ANDROID
Bernafon AG
185792
In Commercial Distribution

  • 05711584083208 ()


  • Hearing aid/implant system remote control
EASYCONTROL-A 1.4 ANDROID
Bernafon AG
178501
In Commercial Distribution

  • 05711583029917 ()


  • Hearing aid/implant system remote control
Onduo App Android
VERILY LIFE SCIENCES LLC
SW0004
In Commercial Distribution

  • 00860000249539 ()


  • Self-care monitoring/reporting software
REMOTEFIT 3.5.0 ANDROID
Sbo Hearing A/S
247220
In Commercial Distribution

  • 05714464060306 ()


  • Hearing aid/implant system remote control
RemoteFit 3.4.0 Android
Sbo Hearing A/S
236789
In Commercial Distribution

  • 05714464042470 ()


  • Hearing aid/implant system remote control
REMOTELINK 1.2 ANDROID
Oticon A/S
176637
In Commercial Distribution

  • 05707131328540 ()


  • Hearing aid/implant system remote control
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