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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
MAICO Diagnostics GmbH
RA660
In Commercial Distribution

  • 04260176121190 ()


  • Tone audiometer
No Description
MAICO Diagnostics GmbH
MA 28
In Commercial Distribution

  • 04260176121114 ()


  • Tone audiometer
encevis is a quantitative EEG trending, spike and seizure detection software. encevis is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings.
AIT Austrian Institute of Technology GmbH
1.12
In Commercial Distribution

  • 09120109830122 ()


  • Bioelectrical signal analysis software
encevis is a quantitative EEG trending, spike and seizure detection software. encevis is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings.
AIT Austrian Institute of Technology GmbH
1.6
In Commercial Distribution

  • 09120109830078 ()


  • Bioelectrical signal analysis software
No Description
CORSCIENCE GmbH & Co. KG
CS20401
In Commercial Distribution

  • 04251341900054 ()


  • Bioelectrical signal analysis software
No Description
MAICO Diagnostics GmbH
MA 42
Not in Commercial Distribution

  • 04260176120902 ()


  • Tone audiometer
No Description
MAICO Diagnostics GmbH
MA 27
In Commercial Distribution

  • 04260176120865 ()


  • Tone audiometer
No Description
MAICO Diagnostics GmbH
MA 1
In Commercial Distribution

  • 04260176120858 ()


  • Tone audiometer
No Description
MAICO Diagnostics GmbH
MA 41
Not in Commercial Distribution

  • 04260176120704 ()


  • Tone audiometer
No Description
MAICO Diagnostics GmbH
MA 25
In Commercial Distribution

  • 04260176120377 ()


  • Tone audiometer
No Description
MICROLIFE USA, INC.
WBP O3 1G 5 schedule
In Commercial Distribution

  • 14719003314375 ()
  • 04719003314378 ()


  • Blood pressure ambulatory recorder
No Description
APOZA ENTERPRISE CO., LTD.
CAM-I
In Commercial Distribution

  • 04719883751522 ()


  • Intraoral camera
No Description
APOZA ENTERPRISE CO., LTD.
CAM-II
In Commercial Distribution

  • 04719883751423 ()


  • Intraoral camera
The A-PULSE CASPal®+ is a noninvasive blood pressure monitoring system which is designed to measure the Central Aortic Systolic Pressure (CASP) based on arterial tonometry at the radial artery of the wrist. It has a built-in Bluetooth module for Bluetooth Serial Port Profile communication with application program.
HEALTHSTATS INTERNATIONAL PTE LTD
T7200 Series
Not in Commercial Distribution

  • 08885014410074 ()


  • Blood pressure ambulatory recorder
The A-PULSE CASPro® is a noninvasive blood pressure monitoring system designed to measure the Central Aortic Systolic Pressure (CASP) and additional arterial pulse waveform related indices based on arterial tonometry at the radial artery of the wrist.
HEALTHSTATS INTERNATIONAL PTE LTD
T7100 Series
Not in Commercial Distribution

  • 08885014410043 ()


  • Blood pressure ambulatory recorder
The MC3100™ is an oscillometric blood pressure monitor for measuring systolic pressure, diastolic pressure and pulse rate.
HEALTHSTATS INTERNATIONAL PTE LTD
T3100 Series
Not in Commercial Distribution

  • 08885014410029 ()


  • Blood pressure ambulatory recorder
BPro® Ambulatory Blood Pressure Monitoring System is a noninvasive ambulatory blood pressure monitoring (ABPM) system based on arterial tonometry at the radial artery and oscillometry at the upper arm. It is used for measuring systolic pressure, diastolic pressure and pulse rate of adults.
HEALTHSTATS INTERNATIONAL PTE LTD
T6200 Series
Not in Commercial Distribution

  • 08885014410012 ()


  • Blood pressure ambulatory recorder
The BPro® BT is used to capture the pulse wave from the radial artery.
HEALTHSTATS INTERNATIONAL PTE LTD
T6200 series
In Commercial Distribution

  • 08885014410005 ()


  • Blood pressure ambulatory recorder
The BPro® device is designed to be worn like a wristwatch and to function as a blood pressure monitor.
HEALTHSTATS INTERNATIONAL PTE LTD
T6200 Series
Not in Commercial Distribution

  • 08885014410104 ()


  • Blood pressure ambulatory recorder
The BPro® BT Ambulatory Blood Pressure Monitoring system is a noninvasive ambulatoryblood pressure monitoring system based on arterial tonometry at the radial artery of the wrist with radial pulse waveform acquisition.
HEALTHSTATS INTERNATIONAL PTE LTD
T6200 series
In Commercial Distribution

  • 08885014410098 ()


  • Blood pressure ambulatory recorder
The BProSOftCASP® 24-Hour Ambulatory Blood Pressure and CASP Monitoring System is a noninvasive ambulatory blood pressure monitoring (ABPM) system based on arterial tonometry at the radial artery and oscillometry at the upper arm. It is used for measuring systolic pressure (SYS), diastolic pressure (DIA), pulse rate (PR) and the Central Aortic Systolic Pressure (CASP) of adults.
HEALTHSTATS INTERNATIONAL PTE LTD
T6300 Series
Not in Commercial Distribution

  • 08885014410081 ()


  • Blood pressure ambulatory recorder
The MC3100™+ is a noninvasive blood pressure monitor for measuring the systolic pressure, diastolic pressure and pulse rate using the oscillometric method. It has a built-in Bluetooth module for Bluetooth Serial Port Profile communication with application program.
HEALTHSTATS INTERNATIONAL PTE LTD
T3100 Series
Not in Commercial Distribution

  • 08885014410067 ()


  • Blood pressure ambulatory recorder
The A-PULSE CASPal® is a noninvasive blood pressure monitoring system which is designed to measure the Central Aortic Systolic Pressure (CASP) based on arterial tonometry at the radial artery of the wrist.
HEALTHSTATS INTERNATIONAL PTE LTD
T7200 Series
Not in Commercial Distribution

  • 08885014410050 ()


  • Blood pressure ambulatory recorder
The A-PULSE CASP® pulse wave analysis system consists of the BPro® radial pulse wave acquisition device, a blood pressure (BP) calibrator and the A-PULSE CASP® pulse wave application software. The BPro® device is used to capture the pulse wave from the radial artery, and the BP calibrator is used to calibrate the pulse wave. Once the pulse wave is calibrated, the software is used to derive the central aortic systolic pressure, radial augmentation index (rAI) and a range of other pulse wave indices. The software allows the pulse wave, blood pressure readings and pulse rate readings to be displayed, stored and printed. The MC3100™ oscillometric blood pressure monitor, or an equivalent, may be used as the BP calibrator.
HEALTHSTATS INTERNATIONAL PTE LTD
T6400 Series
Not in Commercial Distribution

  • 08885014410036 ()


  • Blood pressure ambulatory recorder
exoplan is a medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patient’s anatomy. The process is based on CT/CBCT data sets originating from other medical devices, and can be supported by optical scan(s) of the patient’s anatomy as well as a virtual prosthetic proposal. exoplan allows the design of surgical guides to support the placement of endosseous dental implants in guided surgery. The design of surgical guides is based on 3D surface data representing the preoperative situation and approved implant positions. Alternatively, instead of optical surface data a second CBCT/CT dataset can be used. The software exports the planning and design results as geometrical data and a digital 3D model of the surgical guide to support the manufacture of a separate physical product. exoplan does not extend or change indications of dental implants. Usage of a surgical guide designed with the software does not change the necessary due diligence required compared to conventional (non-guided) surgery. The software is intended to be used only by dental professionals with sufficient medical training in dental implantology and surgical dentistry in office environments suitable for reading diagnostic dental DICOM data sets. exoplan shall not be used for any purpose other than planning dental implant placement or design of surgical guides.
exocad GmbH
3.1 Rijeka
In Commercial Distribution

  • 04260521365026 ()


  • Dental treatment application software
exoplan is a medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patient’s anatomy. The process is based on CT/CBCT data sets originating from other medical devices, and can be supported by optical scan(s) of the patient’s anatomy as well as a virtual prosthetic proposal. exoplan allows the design of surgical guides to support the placement of endosseous dental implants in guided surgery. The design of surgical guides is based on 3D surface data representing the preoperative situation and approved implant positions. Alternatively, instead of optical surface data a second CBCT/CT dataset can be used. The software exports the planning and design results as geometrical data and a digital 3D model of the surgical guide to support the manufacture of a separate physical product. exoplan does not extend or change indications of dental implants. Usage of a surgical guide designed with the software does not change the necessary due diligence required compared to conventional (non-guided) surgery. The software is intended to be used only by dental professionals with sufficient medical training in dental implantology and surgical dentistry in office environments suitable for reading diagnostic dental DICOM data sets. exoplan shall not be used for any purpose other than planning dental implant placement or design of surgical guides.
exocad GmbH
3.0 Galway
In Commercial Distribution

  • 04260521365019 ()


  • Dental treatment application software
exoplan is a medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patient’s anatomy. The process is based on CT/CBCT data sets originating from other medical devices, and can be supported by optical scan(s) of the patient’s anatomy as well as a virtual prosthetic proposal. exoplan allows the design of surgical guides to support the placement of endosseous dental implants in guided surgery. The design of surgical guides is based on 3D surface data representing the preoperative situation and approved implant positions. The software exports the planning and design results as geometrical data and a digital 3D model of the surgical guide to support the manufacture of a separate physical product. exoplan does not extend or change indications of dental implants. Usage of a surgical guide designed with the software does not change the necessary due diligence required compared to conventional (non-guided) surgery. The software is intended to be used only by dental professionals with sufficient medical training in dental implantology and surgical dentistry in office environments suitable for reading diagnostic dental DICOM data sets. exoplan shall not be used for any purpose other than planning dental implant placement or design of surgical guides.
exocad GmbH
2.3 Matera
In Commercial Distribution

  • 04260521365002 ()


  • Dental treatment application software
No Description
Osstell AB
Osstell OsstellConnect
In Commercial Distribution

  • 09010522001073 ()


  • Dental treatment application software
Striped Red Tubing 100pk
ETYMOTIC RESEARCH, INC.
ER3-21TR
In Commercial Distribution

  • 00846430004634 ()
  • 00846430004887 ()


  • Tone audiometer
Home Hearing Test
ETYMOTIC RESEARCH, INC.
ER120 HHT
In Commercial Distribution

  • 00846430004023 ()


  • Tone audiometer
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