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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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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

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

Blue Sky Bio, LLC. - 00810060226346

Blue Sky Plan Software
BLUE SKY BIO LLC
5.0
In Commercial Distribution

  • 00810060226346 ()
BSP

  • Dental treatment application software

Swissmeda powered by Carestream Dental - 60192155944543

Swissmeda powered by Carestream Dental
CARESTREAM DENTAL LLC
5944541
In Commercial Distribution

  • 60192155944543 ()
5944541

  • Dental treatment application software

Blue Sky Bio, LLC. - 00810060226063

Blue Sky Plan Software
BLUE SKY BIO LLC
4.13
In Commercial Distribution

  • 00810060226063 ()
BSP

  • Dental treatment application software

PXL - 00813557020243

PXL Intraoral Camera
Digital Doc LLC
PXL-1000
In Commercial Distribution

  • 00813557020243 ()
PXL-1000

  • Intraoral camera

Iris - 00813557020205

IRIS X90 Intraoral Camera
Digital Doc LLC
X90
In Commercial Distribution

  • 00813557020205 ()
IRIS-X90

  • Intraoral camera

Iris - 00813557020144

IRIS X80 Intraoral Camera
Digital Doc LLC
X80
In Commercial Distribution

  • 00813557020144 ()
IRIS-X80

  • Intraoral camera

Iris - 00813557020007

IRIS USB 2.0 Intraoral Camera
Digital Doc LLC
Iris-1000
In Commercial Distribution

  • 00813557020007 ()
IRIS-1000

  • Intraoral camera

Blue Sky Bio, LLC. - 00815131026726

No Description
BLUE SKY BIO LLC
4.12
In Commercial Distribution

  • 00815131026726 ()
BSP

  • Dental treatment application software

Blue Sky Bio, LLC. - 00815131026412

No Description
BLUE SKY BIO LLC
Blue Sky Plan Software
In Commercial Distribution

  • 00815131026412 ()


  • Dental treatment application software

MedTrakVNG Goggle - B292M9205200

No Description
MEDTRAK VNG, INC.
M920520
In Commercial Distribution

  • B292M9205200 ()


  • Eye movement analysis system

MedTrakVNG Interface Controller - B292M9203020

No Description
MEDTRAK VNG, INC.
M920302
In Commercial Distribution

  • B292M9203020 ()


  • Eye movement analysis system

MobiTrakVNG Receiver - B292M9174150

No Description
MEDTRAK VNG, INC.
M917415
In Commercial Distribution

  • B292M9174150 ()


  • Eye movement analysis system

MobiTrak Software v3.00 - B292M9170810

No Description
MEDTRAK VNG, INC.
M917081
In Commercial Distribution

  • B292M9170810 ()


  • Eye movement analysis system

MedTrakVNG Footswitch - B2924091070

No Description
MEDTRAK VNG, INC.
40-9107
In Commercial Distribution

  • B2924091070 ()


  • Eye movement analysis system

MedTrakVNG MobiTrak System - B2924040100

No Description
MEDTRAK VNG, INC.
40-4010
In Commercial Distribution

  • B2924040100 ()


  • Eye movement analysis system

SHOEBOX AUDIOMETRY - B348SHOEBOXAUDIOMETER0

No Description
SHOEBOX Ltd
SHOEBOXAUDIOMETER
In Commercial Distribution

  • B348SHOEBOXAUDIOMETER0 ()


  • Tone audiometer

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 - B202BCSEG0

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

  • B202BCSEG0 ()
BCSEG

  • Bioelectrical signal analysis software

BC - B202BC0

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

  • B202BC0 ()
BC

  • 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

SmartAudiometer Software - 00817020020877

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M817000
In Commercial Distribution

  • 00817020020877 ()


  • Tone audiometer

SmartTrOAE Software - 00817020020860

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M814000
In Commercial Distribution

  • 00817020020860 ()


  • Bioelectrical signal analysis software

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
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