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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PLS13K/TG KIRKLAND CHISEL 1P
Peter Brasseler Holdings, LLC
5025458U0
In Commercial Distribution

  • 00887919759911 ()


  • Dental osteotome
XiVE® TG AuroBase D3.4-4.5
Dentsply Implants Manufacturing GmbH
32254520
In Commercial Distribution

25-4520

  • Dental implant suprastructure, permanent, preformed
XiVE® TG Abutment Screw
Dentsply Implants Manufacturing GmbH
32254300
In Commercial Distribution

25-4300

  • Dental implant suprastructure, permanent, preformed
XiVE® TG Castable Coping
Dentsply Implants Manufacturing GmbH
32254242
In Commercial Distribution

25-4242

  • Dental implant suprastructure kit
XiVE® TG Coping Screw
Dentsply Implants Manufacturing GmbH
32254200
In Commercial Distribution

25-4200

  • Dental implant suprastructure, permanent, preformed
VA 20mm FLL TG- VF
WEST PHARMA. SERVICES IL, . LTD
8072035
In Commercial Distribution

  • 27290108240652 ()
  • 17290108240655 ()
  • 07290108240658 ()


  • Vial/bottle adaptor, non-hermetic
No Description
Get-Grin Inc.
Initial Release
In Commercial Distribution

  • D962GGA00001 ()


  • Radiological PACS software
Clue is a digital smartphone application helping people with cycles better understand their menstrual and reproductive health. There are three different modes for users to pick from, depending on what suits their current goal best Clue Period Tracking, Clue Conceive, and Clue Pregnancy. Across all modes there are different features that allow users to track their health experiences, access current scientific literature, and learn more about what’s happening to their body. Both a free version and a paid premium version of the app, called Clue Plus, are available to users. Clue Conceive is a mode of the Clue app. Clue Conceive's proprietary algorithm uses period start date information entered by the user to provide predictions on the best days to try and conceive.
BioWink GmbH
Android
In Commercial Distribution

  • 04260749840046 ()


  • Self-care monitoring/reporting software
Optionally, the electrostimulator (SPM01M1) can require the combined use with the MySPM mobile application, as accessory of the Subject device. It allows to monitor the user and guide rehabilitation and training through specific protocols.
NCS LAB SRL
SPM01A1
In Commercial Distribution

  • 08051122040926 ()
SPM01A1

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
APPLE INC.
Feature Version 1.x
In Commercial Distribution

  • 00190198909534 ()


  • Cardiopulmonary physiological parameter analysis software
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