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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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Vocal Parts and Vocal Pathology I & II Software
PENTAX OF AMERICA, INC.
9225
In Commercial Distribution

  • 04961333230358 ()


  • Electroglottograph
Applied Speech Science for Voice & Resonance Disorders, Software
PENTAX OF AMERICA, INC.
5156
Not in Commercial Distribution

  • 04961333229871 ()


  • Electroglottograph
Leica Biosystems CytoVision FISH review software (inc. dongle)
Leica Biosystems Richmond, Inc.
23SWR000FXX001
Not in Commercial Distribution

  • 00849832004318 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision FISH Software License Activition Code
Leica Biosystems Richmond, Inc.
23SWR000FLX001
Not in Commercial Distribution

  • 00849832004301 ()

  • Device Size Text, specify:


  • Microscope objective
Leica Biosystems CytoVision CGH Software License Activation Code
Leica Biosystems Richmond, Inc.
23SWR000CGX001
Not in Commercial Distribution

  • 00849832004288 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Care Orchestrator, Medical equipment clinical data interfacing software
Respironics, Inc.
1.24
In Commercial Distribution

  • 00606959057760 ()
1126366

  • Medical equipment clinical data interfacing software
Care Orchestrator, Medical equipment clinical data interfacing software
Respironics, Inc.
1.23
In Commercial Distribution

  • 00606959057500 ()
1126366

  • Medical equipment clinical data interfacing software
Lumax™ TS Pro • EMG Software Upgrade Kit
Coopersurgical, Inc.
53366
In Commercial Distribution

  • 60888937013452 ()


  • Urodynamic measurement system
ARCS ABP Analysis & Reporting Software & Dongle w/Bluetooth
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020290 ()
A10-0118-60

  • Electrocardiographic long-term ambulatory recording analyser application software
CB Series Analysis & Reporting Software - 3 CH ECG
VASOMEDICAL, INC.
CB Series S/W
In Commercial Distribution

  • 00817980020146 ()
A10-0032

  • Electrocardiographic long-term ambulatory recording analyser application software
NAVIPLAN, CT Planning Software for Total Hip Replacement
Naviswiss AG
NS053
In Commercial Distribution

  • 07640176970535 ()


  • Orthopaedic/craniofacial implantation planning software
4Klearity Med X Change Brand Software Version 7.12.1.2
Nds Surgical Imaging LLC
4KR100
Not in Commercial Distribution

  • 00817613021021 ()


  • Endoscopic video image processing unit
GoCheck Kids stand-alone software for the Nokia device.
Gobiquity, Inc.
Nokia 4.4.36
In Commercial Distribution

  • B430GCKNOK44360 ()


  • External ocular measurement camera
Aurora Xi Plasmapheresis System with Software Version 2.0
Fresenius Kabi AG
Software Version 2.0
In Commercial Distribution

  • 00810020442199 ()


  • Apheresis system
Software version for AMICUS Separator Life Extension Device
Fresenius Kabi AG
6.1.122.0
In Commercial Distribution

  • 00810020441192 ()


  • Apheresis system
Software version for AMICUS Separator Life Extension Device
Fresenius Kabi AG
6.1.113.0
In Commercial Distribution

  • 00810020440607 ()


  • Apheresis system
Aurora Xi Plasmapheresis System with Software Version 2.1
Fresenius Kabi AG
Software Version 2.1
In Commercial Distribution

  • 00810020440560 ()


  • Apheresis system
Software version for AMICUS Separator life extension device
Fresenius Kabi AG
6.0
In Commercial Distribution

  • 00810020440171 ()


  • Apheresis system
Stellaris PC with Laser with Version 4+ Software
Bausch & Lomb Incorporated
BL14304
In Commercial Distribution

  • 00757770520251 ()
BL14304

  • Phacoemulsification/vitrectomy system
Stellaris Vision Enhancement System with Version 4+ Software
Bausch & Lomb Incorporated
BL11114
In Commercial Distribution

  • 00757770520190 ()
BL11114

  • Phacoemulsification/vitrectomy system
Stellairs PC Combined System with Version 4+ Software
Bausch & Lomb Incorporated
BL14334
In Commercial Distribution

  • 00757770519996 ()
BL14334

  • Phacoemulsification/vitrectomy system
Stellaris PC with Laser with Version 4+ Software
Bausch & Lomb Incorporated
BL14304
Not in Commercial Distribution

  • 00757770519897 ()
BL14304

  • Phacoemulsification/vitrectomy system
VP 2000 System Software v2.1 with Protocols USB
ABBOTT MOLECULAR INC.
02J11-057
In Commercial Distribution

  • 00884999048478 ()
02J11-057

  • Tissue processor IVD, automated/semi-automated
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)
Philips Oy
MRCAT Brain / RTgo 4.1
In Commercial Distribution

  • 00884838098206 ()
781439

  • MRI system application software
DynaCAD is a MR image analysis software medical device that consists of MR Analysis Server, Viewer application, and Interventional Planning application.
Philips DS North America LLC
5
In Commercial Distribution

  • 00884838094857 ()
4598-016-98182, 3000-103-14352, 300011916421

  • 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)
Philips Oy
MRCAT Brain / RTgo 4.0
In Commercial Distribution

  • 00884838094093 ()
781439

  • 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
784026
In Commercial Distribution

  • 00884838089648 ()


  • Ultrasound imaging system application software
DynaLync Prostate
Philips DS North America LLC
784016
Not in Commercial Distribution

  • 00884838085510 ()


  • MRI system application software
UroNav Version 3
Philips DS North America LLC
459801572611
In Commercial Distribution

  • 00884838091818 ()


  • Ultrasound imaging system application software
DynaCAD is a MR image analysis software medical device that consists of MR Analysis Server, Viewer application, and Interventional Planning application.
Philips DS North America LLC
4.0
In Commercial Distribution

  • 00884838086630 ()


  • MRI system application software
DynaLoc Prostate 3.5
Philips DS North America LLC
98960321004
In Commercial Distribution

  • 00884838082885 ()


  • 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.
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
iLet Bionic Pancreas (Pharmacy Starter Kit)
Beta Bionics, Inc.
Insulin Only
In Commercial Distribution

  • 00850050080206 ()
BB1004

  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
iLet Bionic Pancreas (Government Starter Kit)
Beta Bionics, Inc.
Insulin Only
In Commercial Distribution

  • 00850050080190 ()
BB1003

  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
iLet Bionic Pancreas (Commercial Starter Kit)
Beta Bionics, Inc.
Insulin Only
In Commercial Distribution

  • 00850050080183 ()
BB1002

  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
iLet Bionic Pancreas (Commercial Starter Kit)
Beta Bionics, Inc.
Insulin Only
In Commercial Distribution

  • 00850050080046 ()
BB1002

  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
iLet Bionic Pancreas (Government Starter Kit)
Beta Bionics, Inc.
Insulin Only
In Commercial Distribution

  • 00850050080039 ()
BB1003

  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
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