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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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twiist Refill Kit without Infusion Set
SEQUEL MED TECH, LLC
RF-90400
In Commercial Distribution

  • 00198617904009 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
twiist Refill Kit with Cleo Infusion Set
SEQUEL MED TECH, LLC
RF-90100
In Commercial Distribution

  • 00198617901008 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
twiist Convenience Starter Kit with Cleo Infusion Set
SEQUEL MED TECH, LLC
CM-10100
In Commercial Distribution

  • 00198617101002 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
HexaVue IP In-Light Camera Control Feature
BLACK DIAMOND VIDEO, INC.
HexaVue IP
In Commercial Distribution

  • 00724995220594 ()
XQHPILCC

  • Operating room audiovisual data/device management system application software
HexaVue IP Surgical Light Control Feature
BLACK DIAMOND VIDEO, INC.
HexaVue IP
In Commercial Distribution

  • 00724995220587 ()
XQHPSLC

  • Operating room audiovisual data/device management system application software
No Description
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
Scansys TA517
In Commercial Distribution

  • 06945087505175 ()


  • Eye anterior segment analyser
MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation therapy planning purposes. MR-RT consists of RTGo SW and MR CouchTop accessory. RTgo is a software that provides MR-RT functionality including MRCAT (MRCAT Prostate, MRCAT Pelvis, MRCAT Brain, MRCAT Head &Neck)
Philips Medical Systems Nederland B.V.
RTgo 5
In Commercial Distribution

  • 00884838122123 ()
781439

  • MRI system application software
MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation therapy planning purposes. MR-RT consists of RTGo SW and MR CouchTop accessory. RTgo is a software that provides MR-RT functionality including MRCAT (MRCAT Prostate, MRCAT Pelvis, MRCAT Brain, MRCAT Head &Neck)
Philips Medical Systems Nederland B.V.
300005806303
In Commercial Distribution

  • 00884838112742 ()
781439

  • MRI system application software
MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation therapy planning purposes. MR-RT consists of RTGo SW and MR CouchTop accessory. RTgo is a software that provides MR-RT functionality including MRCAT (MRCAT Prostate, MRCAT Pelvis, MRCAT Brain, MRCAT Head &Neck)
Philips Oy
RTgo 5.0 5
Not in Commercial Distribution

  • 00884838107311 ()
300005806302

  • MRI system application software
UroNav is a medical image processing device that provides image-guided intervention and diagnostic information, which guides interventional instrumentation to targets that have been defined by the physician.
Philips DS North America LLC
UroNav 4
In Commercial Distribution

  • 00884838107069 ()
784039

  • Ultrasound imaging system application software
No Description
THE MAGSTIM COMPANY LIMITED
6251-00
In Commercial Distribution

  • 05060229533081 ()


  • Clinical management support software
No Description
THE MAGSTIM COMPANY LIMITED
6261-00
In Commercial Distribution

  • 05060229533074 ()


  • Clinical management support software
No Description
THE MAGSTIM COMPANY LIMITED
5736-00
In Commercial Distribution

  • 05060229532794 ()


  • Clinical management support software
No Description
THE MAGSTIM COMPANY LIMITED
5453-00
In Commercial Distribution

  • 05060229532725 ()


  • Clinical management support software
CytoVision V7.6 configuration
Leica Biosystems Richmond, Inc.
23SWR00076CV
Not in Commercial Distribution

  • 00849832013419 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision 7.5 Warranty upgrade DVD
Leica Biosystems Richmond, Inc.
23SWRWAR750
Not in Commercial Distribution

  • 00849832011620 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision V7.5 configuration
Leica Biosystems Richmond, Inc.
23SWR00075CV
Not in Commercial Distribution

  • 00849832011613 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision V7.4 configuration
Leica Biosystems Richmond, Inc.
23SWR000CVX740
Not in Commercial Distribution

  • 00849832010753 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems Ariol TMA Module
Leica Biosystems Richmond, Inc.
23ASWTMA
In Commercial Distribution

  • 00849832007845 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems Ariol Batch Processing Module
Leica Biosystems Richmond, Inc.
23ASWBATCH
In Commercial Distribution

  • 00849832007821 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems Ariol Slide Exporter (SCN for DIH)
Leica Biosystems Richmond, Inc.
23ASASE
In Commercial Distribution

  • 00849832007814 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision CytoLink Development System
Leica Biosystems Richmond, Inc.
23REV009KFXCL1
Not in Commercial Distribution

  • 00849832005001 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision CytoLink Data Service Module
Leica Biosystems Richmond, Inc.
23SVRCYTOLINK
Not in Commercial Distribution

  • 00849832004998 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision Station upgrade use existing Jai M4
Leica Biosystems Richmond, Inc.
23CUP003CVX720
Not in Commercial Distribution

  • 00849832004578 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision Capture station upgrade use existing DFC
Leica Biosystems Richmond, Inc.
23CUP004CVX710
Not in Commercial Distribution

  • 00849832004516 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision Station Upgrade use existing Jai CVM2
Leica Biosystems Richmond, Inc.
23CUP005CVMV2
Not in Commercial Distribution

  • 00849832004493 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision Station Upgrade existing Dual Jai CVM4
Leica Biosystems Richmond, Inc.
23CUP005CVMV4
Not in Commercial Distribution

  • 00849832004486 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision Station Upgrade use existing Jai A10
Leica Biosystems Richmond, Inc.
23CUP006CVXA10
Not in Commercial Distribution

  • 00849832004479 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision Station Upgrade use existing Dual Jai A10
Leica Biosystems Richmond, Inc.
23CUP008CVXA10
Not in Commercial Distribution

  • 00849832004462 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision GSL10 to GSL120 Stacker Upgrade
Leica Biosystems Richmond, Inc.
23GSL010UPG120
Not in Commercial Distribution

  • 00849832004448 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
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