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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
CCA-200 Mini Audiometer
In Commercial Distribution

  • 04260176127673 ()


  • Tone audiometer
No Description
MAICO Diagnostics GmbH
CCA-200 Mini
In Commercial Distribution

  • 04260176127666 ()


  • Tone audiometer
No Description
MAICO Diagnostics GmbH
CCA-200 Mini Audiometer
In Commercial Distribution

  • 04260176127659 ()


  • Tone audiometer
No Description
MAICO Diagnostics GmbH
CCF-200 Fit Test
In Commercial Distribution

  • 04260176127635 ()


  • Tone audiometer
No Description
MAICO Diagnostics GmbH
CCA-100 Mini Audiometer
In Commercial Distribution

  • 04260176127628 ()


  • Tone audiometer
No Description
MAICO Diagnostics GmbH
MA 42
In Commercial Distribution

  • 04260176127444 ()


  • Tone audiometer
No Description
MAICO Diagnostics GmbH
RA360
In Commercial Distribution

  • 04260176127369 ()


  • Tone audiometer
No Description
MAICO Diagnostics GmbH
Pilot Test
In Commercial Distribution

  • 04260176126935 ()


  • Tone audiometer
No Description
MAICO Diagnostics GmbH
MA 33
In Commercial Distribution

  • 04260176121961 ()


  • Tone audiometer
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
No Description
PAR Medizintechnik GmbH & Co. Kommanditgesellschaft
2001589-202
In Commercial Distribution

  • 04260671371021 ()


  • 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
Orpyx Custom Sensory Insole refill is includes the a replacement set of insoles for the Orpyx Custom Sensory Insole system. This package contains only the insoles and product documentation such as an Instruction for Use manual. The Orpyx Custom Sensory Insole system consists of a powered limb overload warning technology to provide real time notifications for pressure offloading. For wellness purposes the system also includes temperature sensors to monitor physiological parameters such as plantar foot skin temperature and motion sensors to measure activity. The Orpyx Custom Sensory Insole is fabricated from a foot impression. The Orpyx Custom Sensory Insole system is intended to act as an adjunct to standard footcare, not a replacement. It is designed for use throughout everyday activities. Orpyx Sensory Insoles system is indicated for people at risk of developing ulcers on the plantar aspect of the foot. The device is a prescription device and is not transferable to another person. The product does not diagnose or treat any conditions, it is meant to be used as an adjunct to current foot care practices.
Orpyx
SI000010
In Commercial Distribution

  • 10185571000516 ()


  • Pressure monitoring insole
The Orpyx Custom Sensory Insole system consists of a powered limb overload warning technology to provide real time notifications for pressure offloading. For wellness purposes the system also includes temperature sensors to monitor physiological parameters such as plantar foot skin temperature and motion sensors to measure activity. The Orpyx Custom Sensory Insole is fabricated from a foot impression. Orpyx Sensory Insoles system is indicated for people at risk of developing ulcers on the plantar aspect of the foot. The device is a prescription device and is not transferable to another person. The product does not diagnose or treat any conditions, it is meant to be used as an adjunct to current foot care practices.
Orpyx
SI000010
In Commercial Distribution

  • 10185571000509 ()


  • Pressure monitoring insole
The Orpyx® Custom Sensory Insole renewal is a pair of custom sensory insoles with 4 months of remote patient monitoring support. The renewal insoles work as part of the Orpyx Sensory Insole system. The following is included: 1 pair of custom insoles - Instructions for use manual - 4 months of RPM support - 3rd party contracted scanning, fitting and dispensing support
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000493 ()
10185571000493

  • Pressure monitoring insole
The Orpyx® Custom Sensory Insole system is designed to help patients at risk of foot ulceration. The system consists of pressure sensors integrated into custom fabricated shoe insoles which wirelessly communicates with a display application running on a smartphone or digital display. In addition to pressure, the device monitors plantar foot temperature and movement. Sensor data is collected by the device and sent to the cloud to enable remote monitoring. The following is included: 1 pair of custom insoles - Digital Display - Charging accessories - Instructions for use manual - 4 months of RPM support - support for scanning, fitting and dispensing.
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000486 ()
10185571000486

  • Pressure monitoring insole
The Orpyx® Custom Sensory Insole system is designed to help patients at risk of foot ulceration. The system consists of pressure sensors integrated into custom fabricated shoe insoles which wirelessly communicates with a display application running on a smartphone or digital display. In addition to pressure, the device monitors plantar foot temperature and movement. Sensor data is collected by the device and sent to the cloud to enable remote monitoring. The following is included: 1 pair of custom insoles - Digital Display - Charging accessories - Instructions for use manual - 6 months of RPM support - support for scanning, fitting and dispensing.
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000479 ()
10185571000479

  • Pressure monitoring insole
The Orpyx® Custom Sensory Insole system is designed to help patients at risk of foot ulceration. The system consists of pressure sensors integrated into custom fabricated shoe insoles which wirelessly communicates with a display application running on a smartphone or digital display. In addition to pressure, the device monitors plantar foot temperature and movement. Sensor data is collected by the device and sent to the cloud to enable remote monitoring. The following is included: 1 pair of custom insoles - Digital Display - Charging accessories - Instructions for use manual - 12 months of RPM support - support for scanning, fitting and dispensing.
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000462 ()
10185571000462

  • Pressure monitoring insole
The Orpyx® Custom Sensory Insole system is designed to help patients at risk of foot ulceration. The system consists of pressure sensors integrated into custom fabricated shoe insoles which wirelessly communicates with a display application running on a smartphone or digital display. In addition to pressure, the device monitors plantar foot temperature and movement. Sensor data is collected by the device and sent to the cloud to enable remote monitoring. The following is included: 1 pair of custom insoles - Digital Display - Charging accessories - Instructions for use manual - 4 months of RPM support
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000417 ()
10185571000417

  • Pressure monitoring insole
Orpyx Flex Sensory Insoles refill (1 pair) - This is a set of pre-fabricated sensory insoles compatible with the Orpyx Sensory Insole system. Included in the package: pre-fabricated sensory insoles - instructions for use manual
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000400 ()
10185571000400

  • Pressure monitoring insole
Orpyx Custom Sensory Insoles refill (1 pair) - This is a set of custom sensory insoles compatible with the Orpyx Sensory Insole system. Included in the package: Pair of custom sensory insoles - instructions for use manual.
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000363 ()
10185571000363

  • Pressure monitoring insole
The Orpyx® Custom Sensory Insole renewal is a pair of custom sensory insoles with 4 months of remote patient monitoring support. The renewal insoles work as part of the Orpyx Sensory Insole system. The following is included: 1 pair of custom insoles - Instructions for use manual - 4 months of RPM support
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000356 ()
10185571000356

  • Pressure monitoring insole
The Orpyx® Custom Sensory Insole system is designed to help patients at risk of foot ulceration. The system consists of pressure sensors integrated into custom fabricated shoe insoles which wirelessly communicates with a display application running on a smartphone or digital display. In addition to pressure, the device monitors plantar foot temperature and movement. Sensor data is collected by the device and sent to the cloud for remote monitoring purposes. The following is included: 1 pair of custom insoles - Digital Display - Charging accessories - Instructions for use manual - 6 months of RPM support
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000349 ()
10185571000349

  • Pressure monitoring insole
The Orpyx® Custom Sensory Insole system is designed to help patients at risk of foot ulceration. The system consists of pressure sensors integrated into custom fabricated shoe insoles which wirelessly communicates with a display application running on a smartphone or digital display. In addition to pressure, the device monitors plantar foot temperature and movement. Sensor data is collected by the device and sent to the cloud for remote monitoring purposes. The following is included: 1 pair of custom insoles - Digital Display - Charging accessories - Instructions for use manual - 12 months of RPM support
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000332 ()
10185571000332

  • Pressure monitoring insole
The Orpyx® Flex Sensory insole system is designed to help patients at risk of foot ulceration. The system consists of pressure sensors integrated into pre-fabricated shoe insoles which wirelessly communicates with a display application running on a smartphone or digital display. In addition to pressure, the device monitors plantar foot temperature and movement. Sensor data is collected by the device and sent to the cloud to enable remote monitoring. The following is included in the Orpyx Flex Sensory Insoles Start Up Kit: - 1 pair of flex insoles - Digital Display - Charging accessories - Instructions for use manual
Orpyx
ORPYXSIV1
In Commercial Distribution

  • 10185571000172 ()
10185571000172

  • Pressure monitoring insole
Therapy cycling feedback software
ACCELERATED CARE PLUS CORP
OmniTourSoftware
In Commercial Distribution

  • 00858703006375 ()


  • Bioelectrical signal analysis software
Bioelectrical signal analysis software; Biomechanical function analysis, interactive rehabilitation system
ACCELERATED CARE PLUS CORP
300800A
In Commercial Distribution

  • 00858703006337 ()


  • Bioelectrical signal analysis software
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