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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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No Description
Interacoustics A/S
AS608
In Commercial Distribution

  • 05711117180244 ()


  • Tone audiometer
No Description
Interacoustics A/S
AD226
In Commercial Distribution

  • 05711117180213 ()


  • Tone audiometer
Automatic Blood Pressure Monitor
Contec Medical Systems Co., Ltd.
ABPM50
In Commercial Distribution

  • 06945040106296 ()


  • Blood pressure ambulatory recorder
Automatic Blood Pressure Monitor
Contec Medical Systems Co., Ltd.
ABPM50
In Commercial Distribution

  • 06945040100348 ()


  • Blood pressure ambulatory recorder
Welch Allyn CardioPerfect Workstation with PC-Based 12-Lead Resting Electrocardiograph, Noninterpretive, AHA ECG Cable, ABPM-7100S Ambulatory Blood Pressure System (Computer Purchased Separately)
WELCH ALLYN, INC.
901047
Not in Commercial Distribution

  • 00732094142488 ()
101450

  • Blood pressure ambulatory recorder
ABPM-7100 Ambulatory Blood Pressure Monitor including Monitor Pouch, Adult Cuff, Adult Plus Cuff, USB Cable; 4 Alkaline AA Batteries (Software Included)
WELCH ALLYN, INC.
901050
In Commercial Distribution

  • 00732094230499 ()
ABPM-7100S

  • Blood pressure ambulatory recorder
IMPLANT STUDIO IPGS (Implant Planning and Surgical Guide) is intended to be used as pre-operative planning soft-ware to plan the placement of one or more implants based on an imported CBCT scan and optionally aligned with a loaded 3D surface scan. The implants are provided by a secured implant library. In addition Virtual Crowns can be used for optimized implant positioning under the esthetical aspect. Further a surgical guide for a guided surgery can be designed and exported for 3rd party fabrication based on the approved implant position. The use of the software requires to have the necessary expertise in implant dentistry.The IMPLANT STUDIO IPGS system must be operated by trained dental practitioners and dental technicians who are skilled in implant dentistry.The IMPLANT STUDIO IPGS software is to be used in general dentist clinics and dental laboratories.
3shape Medical A/S
2016-1
Not in Commercial Distribution

  • 05902768365306 ()


  • Dental treatment application software
3Shape Implant Studio® is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in dental implantology and surgical dentistry. This software reads imaging information output from medical scanners such as CT and optical scanners. It allows pre-operative simulation and evaluation of patient anatomy and dental implant placement. Surgical guides and the planned implant position can be exported as 3D models and the guides can be manufactured using said 3D models when used as input to 3D manufacturing systems.
3shape A/S
R1.4
In Commercial Distribution

  • 05902729753845 ()


  • Dental treatment application software
The 3Shape Automate software is a web service for automatic design of crowns
3shape A/S
R1.2
In Commercial Distribution

  • 05902729753821 ()


  • Dental treatment application software
3Shape Implant Studio® is an implant planning and surgery planning software tool intended for use by dental professionals who have appropriate knowledge in dental implantology and surgical dentistry. This software reads imaging information output from medical scanners such as CT and optical scanners. It allows pre-operative simulation and evaluation of patient anatomy and dental implant placement. Surgical guides and the planned implant position can be exported as 3D models and the guides can be manufactured using said 3D models when used as input to 3D manufacturing systems.
3shape A/S
R1.3
In Commercial Distribution

  • 05902729753692 ()


  • Dental treatment application software
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