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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Connect Software Version 5.0.0
SIRONA Dental Systems GmbH
6686831
In Commercial Distribution

  • E27666868310 ()


  • CAD/CAM software
CEREC Software Version 5.0.0
SIRONA Dental Systems GmbH
6682228
In Commercial Distribution

  • E27666822280 ()


  • CAD/CAM software
CEREC Premium 4.4.4 Software
SIRONA Dental Systems GmbH
6612985
In Commercial Distribution

  • E27666129850 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
CEREC Premium CAM 4.4.4 Software
SIRONA Dental Systems GmbH
6610591
In Commercial Distribution

  • E27666105910 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
CEREC Premium CAM 4.5.0 Software
SIRONA Dental Systems GmbH
6610443
In Commercial Distribution

  • E27666104430 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
CEREC Premium 4.5.0 Software
SIRONA Dental Systems GmbH
6610435
In Commercial Distribution

  • E27666104350 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
inLab CAM 16.0 Software
SIRONA Dental Systems GmbH
6610161
In Commercial Distribution

  • E27666101610 ()


  • Dental implant abutment analog, intraoral-scanning, single-use
No Description
FOURNITURES HOSPITALIERES INDUSTRIE
0100011575
In Commercial Distribution

  • 03661489709067 ()


  • Orthopaedic/craniofacial implantation planning software
No Description
RENISHAW MAYFIELD
neuroinspire SW Atlas Module
In Commercial Distribution

  • 03662724000482 ()
001.0123

  • Neurological stereotactic surgery system
No Description
RENISHAW MAYFIELD
neuroinspire planning software
In Commercial Distribution

  • 03662724000390 ()
001.0142

  • Neurological stereotactic surgery system
No Description
EUROIMMUN Medizinische Labordiagnostika AG
YG 0671-0101-2
In Commercial Distribution

  • 04049016151012 ()


  • Laboratory instrument/analyser application software IVD
moorVMS-TREND PC software is intended for use with moorVMS-LDF and moorVMS-OXY, for long term blood flow and tissue oxygen trend monitoring. It is intended for a variety of physiological and clinical research applications in clinical settings. The clinical value of measurements in disease states has not been established. The moorVMS-TREND is not intended to be used as the sole basis for diagnosis or therapy. The moorVMS-TREND Software is not intended for critical care monitoring where loss of function could result in harm to the patient.
MOOR INSTRUMENTS LIMITED
1
In Commercial Distribution

  • 15060484490164 ()


  • Tissue saturation oximeter
  • Laser Doppler blood flowmeter
Clinical software for micro vascular assessments in physiological research and clinical applications.
MOOR INSTRUMENTS LIMITED
2
In Commercial Distribution

  • 15060484490102 ()


  • Laser Doppler blood flowmeter
AXP Accessory
Thermogenesis Corp.
7-00-288
In Commercial Distribution

  • 00886368000513 ()
7-00-288

  • Cryobiological storage container
SW000795 NGTELL7x-S Telligence Bridge Software, v7.4+
Ascom (Sweden) AB
7.x
In Commercial Distribution

  • 17350088671426 ()


  • Nurse call system
No Description
M DIALYSIS INC.
English
In Commercial Distribution

  • 07332699000751 ()
8001027

  • Bedside information system
No Description
Orthosoft Inc
20-8060-400-01
In Commercial Distribution

  • 00887868525681 ()
20-8060-400-01

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Dental Imaging software update only
CARESTREAM HEALTH, INC.
Dental Imaging Software
In Commercial Distribution

  • 60889971045072 ()
1045079

  • General-purpose dental x-ray system application software
SFW KIT 9735738 STEALTH S8 CRN DBS
MEDTRONIC NAVIGATION, INC.
9735738
In Commercial Distribution

  • 00763000378424 ()


  • Neurological stereotactic surgery system
SFW KIT 9735736 STEALTH S8 ENT
MEDTRONIC NAVIGATION, INC.
9735736
In Commercial Distribution

  • 00763000376215 ()


  • ENT stereotactic surgery system
SFW KIT 9735737 STEALTH S8 CRANIAL
MEDTRONIC NAVIGATION, INC.
9735737
In Commercial Distribution

  • 00763000374167 ()


  • Neurological stereotactic surgery system
SFW KIT 9735739 STEALTH S8 STEREOTX
MEDTRONIC NAVIGATION, INC.
9735739
In Commercial Distribution

  • 00763000373580 ()


  • Neurological stereotactic surgery system
SFW 9735762 APP STEALTH S8 APPLICATION
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00763000368494 ()


  • Multi-purpose stereotactic surgery system
SFW 9735762 APP STEALTH S8 APPLICATION
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00763000125295 ()


  • Multi-purpose stereotactic surgery system
SFW KIT 9735739 STEALTH S8 STEREOTX
MEDTRONIC NAVIGATION, INC.
9735739
In Commercial Distribution

  • 00763000125004 ()


  • Neurological stereotactic surgery system
SFW KIT 9735738 STEALTH S8 CRN DBS
MEDTRONIC NAVIGATION, INC.
9735738
In Commercial Distribution

  • 00763000124991 ()


  • Neurological stereotactic surgery system
SFW KIT 9735737 STEALTH S8 CRANIAL
MEDTRONIC NAVIGATION, INC.
9735737
In Commercial Distribution

  • 00763000117009 ()


  • Neurological stereotactic surgery system
SFW KIT 9735736 STEALTH S8 ENT
MEDTRONIC NAVIGATION, INC.
9735736
In Commercial Distribution

  • 00763000116996 ()


  • ENT stereotactic surgery system
SFW KIT 9735737 STEALTH S8 CRANIAL
MEDTRONIC NAVIGATION, INC.
9735737
In Commercial Distribution

  • 00763000070625 ()


  • Neurological stereotactic surgery system
SFW KIT 9735736 STEALTH S8 ENT
MEDTRONIC NAVIGATION, INC.
9735736
In Commercial Distribution

  • 00763000075309 ()


  • ENT stereotactic surgery system
SFW KIT 9735921 S8 DBS STEREOTX
MEDTRONIC NAVIGATION, INC.
9735921
In Commercial Distribution

  • 00763000075224 ()


  • Neurological stereotactic surgery system
SFW KIT 9735916 S8 CRANIAL PLAN STATION
MEDTRONIC NAVIGATION, INC.
9735916
In Commercial Distribution

  • 00763000075170 ()


  • Neurological stereotactic surgery system
SFW KIT 9735739 STEALTH S8 STEREOTX
MEDTRONIC NAVIGATION, INC.
9735739
In Commercial Distribution

  • 00763000075132 ()


  • Neurological stereotactic surgery system
SFW KIT 9735736 STEALTH S8 ENT EU-SC
MEDTRONIC NAVIGATION, INC.
9735736
In Commercial Distribution

  • 00763000075095 ()


  • ENT stereotactic surgery system
SFW KIT 9735736 STEALTH S8 ENT EU-SD
MEDTRONIC NAVIGATION, INC.
9735736
In Commercial Distribution

  • 00763000075088 ()


  • ENT stereotactic surgery system
SFW KIT 9735736 STEALTH S8 ENT EU-NW
MEDTRONIC NAVIGATION, INC.
9735736
In Commercial Distribution

  • 00763000075071 ()


  • ENT stereotactic surgery system
SFW KIT 9735738 STEALTH S8 CRN DBS
MEDTRONIC NAVIGATION, INC.
9735738
In Commercial Distribution

  • 00763000075125 ()


  • Neurological stereotactic surgery system
SFW KIT 9735736 STEALTH S8 ENT EU-SW
MEDTRONIC NAVIGATION, INC.
9735736
In Commercial Distribution

  • 00763000075118 ()


  • ENT stereotactic surgery system
SFW KIT 9735736 STEALTH S8 ENT EU-SE
MEDTRONIC NAVIGATION, INC.
9735736
In Commercial Distribution

  • 00763000075101 ()


  • ENT stereotactic surgery system
SFW KIT 9735736 STEALTH S8 ENT EU-E
MEDTRONIC NAVIGATION, INC.
9735736
In Commercial Distribution

  • 00763000075064 ()


  • ENT stereotactic surgery system
SFW KIT 9735737 STEALTH S8 CRANIAL EU-SE
MEDTRONIC NAVIGATION, INC.
9735737
In Commercial Distribution

  • 00763000074951 ()


  • Neurological stereotactic surgery system
No Description
Gynesonics, Inc.
SW-002
In Commercial Distribution

  • 10817929020340 ()
SW-002

  • Ultrasound-guided radio-frequency ablation system software
B125/B105 V1.5 SW PACK (USB) - MD
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V1.5
Not in Commercial Distribution

  • 00840682141291 ()


  • General-purpose multi-parameter bedside monitor
PRODUCT SOFTWARE MMT-7350 V2.2A
MEDTRONIC MINIMED, INC.
MMT-7350
In Commercial Distribution

  • 00763000242787 ()


  • Patient health record information system application software
SFW KIT 9735738 STEALTH S8 CRN DBS
MEDTRONIC NAVIGATION, INC.
9735738
In Commercial Distribution

  • 00763000238902 ()


  • Neurological stereotactic surgery system
SFW KIT 9735736 STEALTH S8 ENT
MEDTRONIC NAVIGATION, INC.
9735736
In Commercial Distribution

  • 00763000238810 ()


  • ENT stereotactic surgery system
SFW KIT 9735739 STEALTH S8 STEREOTX
MEDTRONIC NAVIGATION, INC.
9735739
In Commercial Distribution

  • 00763000238650 ()


  • Neurological stereotactic surgery system
SFW 9735762 APP STEALTH S8 APPLICATION
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00763000234867 ()


  • Multi-purpose stereotactic surgery system
SFW KIT 9735737 STEALTH S8 CRANIAL EU-SW
MEDTRONIC NAVIGATION, INC.
9735737
In Commercial Distribution

  • 00763000234812 ()


  • Neurological stereotactic surgery system
SFW KIT 9735737 STEALTH S8 CRANIAL
MEDTRONIC NAVIGATION, INC.
9735737
In Commercial Distribution

  • 00763000234799 ()


  • Neurological stereotactic surgery system
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