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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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Benson - 04260176127635

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

  • 04260176127635 ()


  • Tone audiometer

Benson - 04260176127628

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

  • 04260176127628 ()


  • Tone audiometer

Maico - 04260176127444

No Description
MAICO Diagnostics GmbH
MA 42
In Commercial Distribution

  • 04260176127444 ()


  • Tone audiometer

TREMETRICS - 04260176127369

No Description
MAICO Diagnostics GmbH
RA360
In Commercial Distribution

  • 04260176127369 ()


  • Tone audiometer

Maico - 04260176126935

No Description
MAICO Diagnostics GmbH
Pilot Test
In Commercial Distribution

  • 04260176126935 ()


  • Tone audiometer

Maico - 04260176121961

No Description
MAICO Diagnostics GmbH
MA 33
In Commercial Distribution

  • 04260176121961 ()


  • Tone audiometer

TREMETRICS - 04260176121190

No Description
MAICO Diagnostics GmbH
RA660
In Commercial Distribution

  • 04260176121190 ()


  • Tone audiometer

Maico - 04260176120902

No Description
MAICO Diagnostics GmbH
MA 42
Not in Commercial Distribution

  • 04260176120902 ()


  • Tone audiometer

Maico - 04260176120865

No Description
MAICO Diagnostics GmbH
MA 27
In Commercial Distribution

  • 04260176120865 ()


  • Tone audiometer

Maico - 04260176120858

No Description
MAICO Diagnostics GmbH
MA 1
In Commercial Distribution

  • 04260176120858 ()


  • Tone audiometer

Maico - 04260176120704

No Description
MAICO Diagnostics GmbH
MA 41
Not in Commercial Distribution

  • 04260176120704 ()


  • Tone audiometer

Maico - 04260176120377

No Description
MAICO Diagnostics GmbH
MA 25
In Commercial Distribution

  • 04260176120377 ()


  • Tone audiometer

Senti Set 1 - 04260223143151

Senti Audiometry (Class 4 Advanced) Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. Senti device with touchscreen AN100097 4. FW Labelprinter AN100414 5. Pure Tone Audiometer Class 4A AN100653 6. Headphone HDA-280 AN100117 7. Power supply AN100083 8. USB data cable AN100089
PATH medical GmbH
100330
Not in Commercial Distribution

  • 04260223143151 ()


  • Tone audiometer

Senti Desktop Flex (Basic Set) - 04260223142987

Senti Desktop Flex Basic Set Content: 1. Case AN100503 2. Inlay Sentiero AN100385 3. Senti Desktop Flex device AN100433 4. Headphone DD-45 AN100306 5. FW Labelprinter AN100414 6. FW Pure Tone Audiometer Class 3 AN100114 7. Bone Conductor B81 AN100888 or B71W AN100344 optionally 8. Patient response button AN100171 9. Power supply AN100524 + AN100525-USA or AN101360 + AN101251-USA optionally 10. USB data cable AN100418
PATH medical GmbH
100470
In Commercial Distribution

  • 04260223142987 ()


  • Tone audiometer

Senti Set 3 - 04260223142970

Senti Audiometry (Class 3 with HF) Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. Senti device with touchscreen AN100097 4. FW Labelprinter AN100414 5. Pure Tone Audiometer Class 3 AN100114 6. Pure Tone Audiometer High Frequency AN100454 7. Headphone HDA-300 AN100630 8. Bone conductor B-71 with Patient Response button AN100214 9. Power supply AN100083 10. USB data cable AN100089
PATH medical GmbH
100460
Not in Commercial Distribution

  • 04260223142970 ()


  • Tone audiometer

Senti Set 2 - 04260223142963

Senti Audiometry (Class 3) Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. Senti device with touchscreen AN100097 4. FW Labelprinter AN100414 5. Pure Tone Audiometer Class 3 AN100114 6. Headphone HDA-280 AN100117 7. Bone conductor B71 with patient response button AN100214 8. Power supply AN100083 9. USB data cable AN100089
PATH medical GmbH
100450
Not in Commercial Distribution

  • 04260223142963 ()


  • Tone audiometer

Maico - 04260176121114

No Description
MAICO Diagnostics GmbH
MA 28
In Commercial Distribution

  • 04260176121114 ()


  • Tone audiometer

Senti Desktop Flex - 04260223145285

Senti Desktop Flex Screening Set Content: 1. Case AN100503 2. Inlay Sentiero AN100385 3. Senti Desktop Flex device AN100433 4. Headphone DD-45 AN100306 5. FW Labelprinter AN100414 6. FW Pure Tone Audiometer Class 4 Advanced AN100653 7. Power supply AN100524 + AN100525-USA or AN101360 + 101251-USA optionally 8. USB data cable AN100418
PATH medical GmbH
100470-SC
In Commercial Distribution

  • 04260223145285 ()


  • Tone audiometer

exoplan - 04260521365026

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 - 04260521365019

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 - 04260521365002

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

SHOEBOX Audiometry - B835SHOEBOXAUDIOMETER0

No Description
SHOEBOX Ltd
SHOEBOXAUDIOMETER
In Commercial Distribution



  • Tone audiometer

HAWK - 08800017900025

Highest resolution 1280 x 720 delivers precise, true-to-life images auto-focus system 15 advanced LED lights for the correct color representation
DXM CO., LTD
HD
In Commercial Distribution

  • 08800017900025 ()


  • Intraoral camera

ABP - 10841522107719

LOANER - ABP ONTRAK MONITOR, MULTI-LINGUAL
SPACELABS HEALTHCARE (WASHINGTON), INC
90227
Not in Commercial Distribution

  • 10841522107719 ()
L-90227-1

  • Blood pressure ambulatory recorder

Spacelabs Healthcare - 10841522106675

Blood Pressure Long-Term Ambulatory Recorder
SPACELABS HEALTHCARE (WASHINGTON), INC
90207
Not in Commercial Distribution

  • 10841522106675 ()
N/A

  • Blood pressure ambulatory recorder

ABP - 10841522105074

Ambulatory Blood Pressure Monitor
SPACELABS HEALTHCARE (WASHINGTON), INC
90217
Not in Commercial Distribution

  • 10841522105074 ()
N/A

  • Blood pressure ambulatory recorder

Ultralite - 10841522105067

ABP ULTRALITE MONITOR,MULTI-LINGUAL
SPACELABS HEALTHCARE (WASHINGTON), INC
Ultralite
In Commercial Distribution

  • 10841522105067 ()
90217A-1

  • Blood pressure ambulatory recorder

OnTrak - 10841522131431

ABP ONTRAK MONITOR, BRAZIL, 90227
SPACELABS HEALTHCARE (WASHINGTON), INC
OnTrak
In Commercial Distribution

  • 10841522131431 ()
90227-8

  • Blood pressure ambulatory recorder

Ontrak - 10841522129629

CUFF,ABP,ADULT,XL,38-50CM/15-20IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129629 ()

  • 38-50 cm OD
  • 15-20 in OD
016-0109-06Q

  • Blood pressure ambulatory recorder

Ontrak - 10841522129612

CUFF,ABP,ADULT,L,32-42CM/13-17IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129612 ()

  • 32-42 cm OD
  • 13-17 in OD
016-0077-07Q

  • Blood pressure ambulatory recorder
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