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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CEREC AI with CEREC Omnicam
SIRONA Dental Systems GmbH
6534791
In Commercial Distribution

  • E27665347910 ()


  • CAD/CAM software
CEREC AI Connect with Omnicam
SIRONA Dental Systems GmbH
6564707
In Commercial Distribution

  • E27665647070 ()


  • CAD/CAM software
FiberOptic Adapter Storzympus to AI
Avalign Technologies, Inc.
72-9883
In Commercial Distribution

  • 00190776191504 ()


  • Fibreoptic retractor handle
Silastic Ring Applicator AI Style
Avalign Technologies, Inc.
72-52205501M
In Commercial Distribution

  • 00190776208462 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
AI AT Compression Screws Tray Assembly
Acumed LLC
AI-1520
In Commercial Distribution

  • 10806378054716 ()


  • Orthopaedic implant/instrument assembling device
AI Female Fitting Ass'y nonperm clips
Avalign Technologies, Inc.
M152332
In Commercial Distribution

  • 00190776189648 ()


  • Electrical-only medical device connection cable, reusable
FIBEROPTIC LIGHT CABLE ADAPTER FOR AI
Avalign Technologies, Inc.
72-52310
In Commercial Distribution

  • 00190776208738 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
The Navigation Probe is an instrument of the EPIONE device. It enables visualizing reference points or anatomical landmarks in the medical images. It allows the verification of patient registration accuracy, using external anatomical landmarks or skin markers.
QUANTUM SURGICAL
02-0044
In Commercial Distribution

  • 03760305400079 ()
02-0044

  • Robotic surgical navigation system
The Needle Guide is an instrument of the EPIONE device. It provides mechanical guidance for rigid straight instruments of a range of external diameter specified in the Technical Specifications.
QUANTUM SURGICAL
02-0027
In Commercial Distribution

  • 03760305400062 ()
02-0027-19G

  • Robotic surgical navigation system
The Navigation Probe is an instrument of the EPIONE device. It enables visualizing reference points or anatomical landmarks in the medical images. It allows the verification of patient registration accuracy, using external anatomical landmarks or skin markers.
QUANTUM SURGICAL
02-0031
Not in Commercial Distribution

  • 03760305400055 ()
02-0031

  • Robotic surgical navigation system
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