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 Class Implantable

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Scan Body with Screw Compatible with Astra Tech OsseoSpeed 3.5/4.0 IOS
Biodenta Swiss AG
CAD-SBATOS3545
In Commercial Distribution

  • 07640169736346 ()
CAD-SBATOS3545

  • Dental implant abutment analog, intraoral-scanning, single-use
No Description
IMPLANT DIRECT SYBRON MANUFACTURING LLC
DA-IOSDriver
In Commercial Distribution

  • 10841307128205 ()
DA-IOSDriver

  • Surgical screwdriver, reusable
myDigitalKnee mobile app is used with a Digital Knee sensor attached to a brace or orthosis and worn by a patient to collect motion data and assist with management of their condition.
OPUM TECHNOLOGIES SERVICES LIMITED
Mobile App iOS
In Commercial Distribution

  • 09413000126259 ()


  • Electronic goniometer/kinesiology sensor
No Description
Phillips-Medisize A/S
iOS (Mobile App)
Not in Commercial Distribution

  • 05713495000053 ()
84601063

  • Medication reminder application software
Software as a Medical Device (SaMD) which operates as a medication reminder and support services; Operates on Apple iOS devices.
Astellas Pharma Us, Inc.
iOS (Version 1)
In Commercial Distribution

  • 00304692416089 ()
DIGI-001

  • Medication reminder application software
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
Not in Commercial Distribution

  • 07392532242373 ()
75750

  • Rectal irrigation system application software
Accessories
CeramTec Schweiz GmbH
301291
In Commercial Distribution

  • 07640161395015 ()
301291

  • Dental implant suprastructure, temporary, preformed, single-use
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
In Commercial Distribution

75750

  • Rectal irrigation system application software
Accessories
CeramTec Schweiz GmbH
301250
In Commercial Distribution

  • 07640161394773 ()
301250

  • Dental implant suprastructure, temporary, preformed, single-use
Accessories
CeramTec Schweiz GmbH
301251
In Commercial Distribution

  • 07640161394780 ()
301251

  • Dental implant suprastructure, temporary, preformed, single-use
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