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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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Wireless Patient Monitor
ATHENA GTX, INC.
WVSM 5.0
In Commercial Distribution

  • B3945000001120 ()
500-0001-12

  • Multiple vital physiological parameter monitoring system, clinical
  • Multiple-patient intensive/general healthcare physiologic monitoring system
Wireless Patient Monitor
ATHENA GTX, INC.
WVSM 5.0
In Commercial Distribution

  • B3945000001010 ()
500-0001-01

  • Multiple-patient intensive/general healthcare physiologic monitoring system
  • Multiple vital physiological parameter monitoring system, clinical
It is a digital capillaroscope with Wi-Fi transmission. With special software and Apps included you can capture photos and videos both from PC and from Smartphone and Tablet.
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-308
Not in Commercial Distribution

  • B1621091 ()


  • Otoscope, direct
It is digital dental scope with Wi-Fi transmission. With special software and Apps included you can capture photos and videos both from PC and from Smartphone and Tablet.
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-307
Not in Commercial Distribution

  • B1621081 ()


  • Otoscope, direct
It is a digital otoscope with Wi-Fi transmission. With special software and Apps included you can capture photos and videos both from PC and from Smartphone and Tablet.
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-306
Not in Commercial Distribution

  • B1621071 ()


  • Otoscope, direct
Table with installed software is used with wireless battery powered probes (different shapes and sizes) to detect a determined range of gamma radiation energies and maximizes sensitivity and directivity.
Kubtec
K0017C01
In Commercial Distribution

  • B619GPROCASETABL2 ()


  • Mobile gamma camera system
The Hybrid Navigation Unit EM is a high performance computer workstation with built-in electromagnetic Localization System. The workstation runs the navigation software NOVA which imports radiologic image via DICOM.
Scopis GmbH
2.2
In Commercial Distribution

  • B057U2040040 ()
U2 040 04

  • Electromagnetic/optical surgical navigation device tracking system
The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting.
CLEAR GUIDE MEDICAL, INC.
CGOHM
In Commercial Distribution

  • B201CGOHM0 ()
  • B201CGOHM1 ()
CG-OH-M

  • Radiological video camera patient positioning/tracking system camera
  • Optical surgical navigation device tracking system
The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting.
CLEAR GUIDE MEDICAL, INC.
CGOH
In Commercial Distribution

  • B201CGOH1 ()
  • B201CGOH0 ()
CG-OH

  • Radiological video camera patient positioning/tracking system camera
  • Optical surgical navigation device tracking system
FedMedMicFiSTD, with white light, is a digital dermatoscope with Wi-Fi transmission. With special software and Apps included you can capture photos and videos both from PC and from Smartphone and Tablet.
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-304
Not in Commercial Distribution

  • B1621051 ()
BTS-304

  • Otoscope, direct
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