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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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SmartDPOAE Software - 00817020020853

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M813000
In Commercial Distribution

  • 00817020020853 ()


  • Bioelectrical signal analysis software

SmartScreener-Plus2 OAE Module - 00817020020846

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M813010
In Commercial Distribution

  • 00817020020846 ()


  • Bioelectrical signal analysis software

SmartScreener-Plus2 AEP Module - 00817020020839

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M812001
In Commercial Distribution

  • 00817020020839 ()


  • Bioelectrical signal analysis software

SmartScreener-Plus2 Screener Launch - 00817020020822

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M812002
In Commercial Distribution

  • 00817020020822 ()


  • Bioelectrical signal analysis software

SmartEP-ASSR Software - 00817020020815

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M811007
In Commercial Distribution

  • 00817020020815 ()


  • Bioelectrical signal analysis software

SmartEP Software - 00817020020808

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M811000
In Commercial Distribution

  • 00817020020808 ()


  • Bioelectrical signal analysis software

SoundField USBBox-to-Amp Cable (RCA Plugs) - 00817020020365

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M025704
In Commercial Distribution

  • 00817020020365 ()


  • Tone audiometer

SoundField USBBox-to-Amp Cable (Mono Plugs) - 00817020020358

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M025701
In Commercial Distribution

  • 00817020020358 ()


  • Tone audiometer

CNS Envision - B485VIS100

Software for use in the review, annotation and analysis of patient data collected using external physiological monitors.
MOBERG RESEARCH INC
VIS-100
In Commercial Distribution

  • B485VIS100 ()


  • Bioelectrical signal analysis software

CNS Envision - B485CNSENV1000

Software for use in the review, annotation and analysis of patient data collected using external physiological monitors.
NATUS NEUROLOGY INCORPORATED
1.03.00
In Commercial Distribution

  • B485CNSENV1000 ()


  • Bioelectrical signal analysis software

GoCheck Audiometric Headphone Assembly - B43061000060

Audiometric Headphone Final Assembly
Gobiquity, Inc.
Sennheiser HD280 Pro
In Commercial Distribution

  • B43061000060 ()


  • Tone audiometer

GoCheck - B43056000011000

Mobile Application for Hearing Screening
Gobiquity, Inc.
Hearing Mobile App V1.0.0
In Commercial Distribution

  • B43056000011000 ()


  • Tone audiometer

Vasomedical-Biox™ Model 1807 Ambulatory Blood Pressure Recorder w/Bluetooth - 00817980020481

Model 1807 Ambulatory Blood Pressure Recorder w/Bluetooth
VASOMEDICAL, INC.
Model 1807 Kit
In Commercial Distribution

  • 00817980020481 ()
A10-1807-00

  • Blood pressure ambulatory recorder

Vasomedical-Biox™ Model 1806 Ambulatory Blood Pressure Recorder - 00817980020474

Model 1806 Ambulatory Blood Pressure Recorder
VASOMEDICAL, INC.
Model 1806 Kit
In Commercial Distribution

  • 00817980020474 ()
A10-1806-00

  • Blood pressure ambulatory recorder

Vasomedical-Biox™ Model 1805 Ambulatory Blood Pressure Recorder - 00817980020467

Model 1805 Ambulatory Blood Pressure Recorder
VASOMEDICAL, INC.
Model 1805 Kit
In Commercial Distribution

  • 00817980020467 ()
A10-1805-00

  • Blood pressure ambulatory recorder

Vasomedical-Biox™ 1807 ABP Monitor With Analysis S/W w/ Bluetooth - 00817980020061

Ambulatory Blood Pressure Recorder w/Bluetooth
VASOMEDICAL, INC.
Model 1807
In Commercial Distribution

  • 00817980020061 ()
A10-1807-01

  • Blood pressure ambulatory recorder

Vasomedical-Biox™ 1806 ABP Monitor With Analysis S/W - 00817980020054

Ambulatory Blood Pressure Recorder
VASOMEDICAL, INC.
Model 1806
In Commercial Distribution

  • 00817980020054 ()
A10-1806-01

  • Blood pressure ambulatory recorder

Vasomedical-Biox™ 1805 Ambulatory Blood Pressure Monitor With Analysis S/W - 00817980020047

Ambulatory Blood Pressure Recorder
VASOMEDICAL, INC.
Model 1805
In Commercial Distribution

  • 00817980020047 ()
A10-0088

  • Blood pressure ambulatory recorder

MSOFT Dental Planning System - 07629999685093

No Description
Swissmeda AG
2.16
Not in Commercial Distribution

  • 07629999685093 ()


  • Dental treatment application software

MSOFT Dental Planning System - 07629999628410

No Description
Swissmeda AG
2.19.0
In Commercial Distribution

  • 07629999628410 ()


  • Dental treatment application software

Swissmeda Dental Planning System - 07629999614178

No Description
Swissmeda AG
2.17.1
In Commercial Distribution

  • 07629999614178 ()


  • Dental treatment application software

Swissmeda Dental Planning System - 07629999065512

No Description
Swissmeda AG
2.15.4
In Commercial Distribution

  • 07629999065512 ()


  • Dental treatment application software

Swissmeda Dental Planning System - 07629999062177

No Description
Swissmeda AG
2.20.0
In Commercial Distribution

  • 07629999062177 ()


  • Dental treatment application software

Swissmeda Dental Planning System - 07629999061569

No Description
Swissmeda AG
2.15.3
Not in Commercial Distribution

  • 07629999061569 ()


  • Dental treatment application software

Swissmeda Dental Planning System - 07629999057654

No Description
Swissmeda AG
2.15.2
Not in Commercial Distribution

  • 07629999057654 ()


  • Dental treatment application software

Swissmeda Dental Planning System - 07629999056985

No Description
Swissmeda AG
2.15.1
Not in Commercial Distribution

  • 07629999056985 ()


  • Dental treatment application software

Swissmeda Dental Planning System - 07629999056220

No Description
Swissmeda AG
2.15
Not in Commercial Distribution

  • 07629999056220 ()


  • Dental treatment application software

MSOFT Dental Planning System - 07629999054356

No Description
Swissmeda AG
2.14.3
Not in Commercial Distribution

  • 07629999054356 ()


  • Dental treatment application software

Swissmeda Dental Planning System - 07629999052505

No Description
Swissmeda AG
2.14.2
Not in Commercial Distribution

  • 07629999052505 ()


  • Dental treatment application software

Swissmeda Dental Planning System - 07629999052109

No Description
Swissmeda AG
2.14.1
Not in Commercial Distribution

  • 07629999052109 ()


  • Dental treatment application software

Swissmeda Dental Planning System - 07629999048713

No Description
Swissmeda AG
2.14
Not in Commercial Distribution

  • 07629999048713 ()


  • Dental treatment application software

BC - B202BC0

No Description
R.J.L. SCIENCES, INC.
BC (Body Composition Software)
In Commercial Distribution

  • B202BC0 ()
BC

  • Bioelectrical signal analysis software

BC - B202BCSEG0

No Description
R.J.L. SCIENCES, INC.
BC (Body Composition Software) Segmental
In Commercial Distribution

  • B202BCSEG0 ()
BCSEG

  • Bioelectrical signal analysis software

Custom Healthcare Systems Inc. - 00811870035227

No Description
Manus Medical, LLC
B9-18339
In Commercial Distribution

  • 20811870035221 ()
  • 00811870035227 ()


  • Mammographic stereotactic biopsy system

Custom Healthcare Systems Inc. - 00811870033360

No Description
Manus Medical, LLC
B9-17972A
In Commercial Distribution

  • 20811870033364 ()
  • 00811870033360 ()


  • Mammographic stereotactic biopsy system

Custom Healthcare Systems Inc. - 00811870033254

No Description
Manus Medical, LLC
B9-17972
In Commercial Distribution

  • 20811870033258 ()
  • 00811870033254 ()


  • Mammographic stereotactic biopsy system

CUSTOM HEALTHCARE SYSTEMS INC - 00811870031830

No Description
Manus Medical, LLC
B9-16261
In Commercial Distribution

  • 00811870031830 ()


  • Mammographic stereotactic biopsy system

Custom Healthcare Systems Inc. - 00811870031649

No Description
Manus Medical, LLC
B9-15263A
In Commercial Distribution

  • 00811870031649 ()


  • Mammographic stereotactic biopsy system

Custom Healthcare Systems Inc. - 00811870031137

No Description
Manus Medical, LLC
B446MM-B
In Commercial Distribution

  • 20811870031131 ()
  • 00811870031137 ()


  • Mammographic stereotactic biopsy system

CUSTOM HEALTHCARE SYSTEMS INC - 00811870030710

No Description
Manus Medical, LLC
B9-18339B
In Commercial Distribution

  • 20811870030714 ()
  • 00811870030710 ()


  • Mammographic stereotactic biopsy system
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