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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SINGLE SUNGLASS
Evolutioneyes, Inc.
NM SUN 2023
In Commercial Distribution

  • 00802807353927 ()


  • Tinted non-prescription spectacles
SINGLE SUNGLASS
Evolutioneyes, Inc.
ME SUN 2023
In Commercial Distribution

  • 00802807353910 ()


  • Tinted non-prescription spectacles
SINGLE SUNGLASS
Evolutioneyes, Inc.
MS SUN 2023
In Commercial Distribution

  • 00802807353903 ()


  • Tinted non-prescription spectacles
No Description
EYEVAN INC.
748 50 2023
In Commercial Distribution

  • 04571445051514 ()


  • Spectacle frame
No Description
EYEVAN INC.
554 47 2023
In Commercial Distribution

  • 04571445049689 ()


  • Spectacle frame
No Description
EYEVAN INC.
414 46 2023
In Commercial Distribution

  • 04571445048651 ()


  • Spectacle frame
No Description
EYEVAN INC.
#414 46 2023
In Commercial Distribution

  • 04571445035347 ()


  • Spectacle frame
No Description
MedicalCommunications GmbH
2023 (Build 2088)
In Commercial Distribution

  • 04260648620039 ()


  • Ophthalmology PACS software
  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
SINGLE READER
Evolutioneyes, Inc.
4221 2023 DEMI MERLOT
In Commercial Distribution

  • 00802807355129 ()


  • Magnifying spectacles
Radiography 7000 M digital mobile is a new motorized mobile x-ray system that includes: 1. Base Unit ( Sedecal Mobile X-ray system - SM-IV, cleared under K232185 August 21, 2023) 2. SkyPlate Family of detectors (Wireless Portable Detectors) and their accessories 3. Eleva WorkSpot In addition, the following accessories can be used together with the system - Raidography 7000 M: - Detector Holder f. Patient Bed - Grid Landsc. SkyPlateE Large - Grid Landscape SkyPlate Large - Grid Portr. SkyPlate E Large - Grid Portrait SkyPlate Large - Grid Portrait SkyPlate Small - Handle for Skyplate Large - Portable Panel Protector - Wireless Detect. Mobile Holder - Set of 50 WPD Hygienic Bags (large) - Set of 50 WPD Hygienic Bags (small)
Philips Medical Systems DMC GmbH
712010
In Commercial Distribution

  • 00884838115521 ()


  • Mobile basic diagnostic x-ray system, digital
No Description
SHIPPERT MEDICAL TECHNOLOGIES, INC
3-H-BA-DV-3X25
Not in Commercial Distribution

  • 00812185036220 ()


  • Liposuction system cannula, single-use
No Description
SHIPPERT MEDICAL TECHNOLOGIES, INC
3-C-1HV-12X15
Not in Commercial Distribution

  • 00812185036190 ()


  • Liposuction system cannula, single-use
No Description
SHIPPERT MEDICAL TECHNOLOGIES, INC
3-C-1HV-14X25
Not in Commercial Distribution

  • 00812185036176 ()


  • Liposuction system cannula, single-use
No Description
SHIPPERT MEDICAL TECHNOLOGIES, INC
3-C-1H1-4X20
Not in Commercial Distribution

  • 00812185036169 ()


  • Liposuction system cannula, single-use
No Description
SHIPPERT MEDICAL TECHNOLOGIES, INC
3-C-TP-3X23
Not in Commercial Distribution

  • 00812185036107 ()


  • Liposuction system cannula, single-use
No Description
SHIPPERT MEDICAL TECHNOLOGIES, INC
3-C-1H1-4X20
Not in Commercial Distribution

  • 00812185036084 ()


  • Liposuction system cannula, single-use
No Description
SHIPPERT MEDICAL TECHNOLOGIES, INC
3-C-1H1-2X20
Not in Commercial Distribution

  • 00812185036077 ()


  • Liposuction system cannula, single-use
No Description
SHIPPERT MEDICAL TECHNOLOGIES, INC
3-C-24H-4X15
Not in Commercial Distribution

  • 00812185036060 ()


  • Liposuction system cannula, single-use
No Description
SHIPPERT MEDICAL TECHNOLOGIES, INC
3-C-1H2-2X30
Not in Commercial Distribution

  • 00812185036053 ()


  • Liposuction system cannula, single-use
No Description
SHIPPERT MEDICAL TECHNOLOGIES, INC
3-C-T60-TP-3X15
Not in Commercial Distribution

  • 00812185036046 ()


  • Liposuction system cannula, single-use
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