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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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Welch Allyn, Inc. - 00732094070194

Welch Allyn CardioPerfect Workstation with PC-Based 12-Lead Resting Electrocardiograph, Automatic ECG Interpretation, AHA ECG Cable, ABPM-6100S Ambulatory Blood Pressure System
WELCH ALLYN, INC.
901047
Not in Commercial Distribution

  • 00732094070194 ()
101444

  • Blood pressure ambulatory recorder

Welch Allyn, Inc. - 00732094070132

Welch Allyn CardioPerfect Workstation with PC-Based 12-Lead Resting Electrocardiograph, Noninterpretive, AHA ECG Cable, ABPM-7100S Ambulatory Blood Pressure System, PC-Based SpiroPerfect Spirometer
WELCH ALLYN, INC.
901047
Not in Commercial Distribution

  • 00732094070132 ()
101452

  • Blood pressure ambulatory recorder

Welch Allyn, Inc. - 00732094069891

Welch Allyn CardioPerfect Workstation with PCE-210 PC-Based 12-Lead Exercise Stress Electrocardiograph, Automatic ECG Interpretation, AHA ECG Cable, Treadmill, Personal Computer with Printer and Cart
WELCH ALLYN, INC.
901047
Not in Commercial Distribution

  • 00732094069891 ()
101457

  • Blood pressure ambulatory recorder

Swoop Site Quality Assurance Phantom - 00860000606134

The Site Quality Assurance Phantom is specifically designed as a medical device and augments the scanner by allowing weekly quality control checks of the functioning of the scanner in the hospital environment.
Hyperfine Operations, Inc.
V1.0 (810-11049-01)
In Commercial Distribution

  • 00860000606134 ()


  • MRI phantom, test object

Synchrony Dysphagia Solutions by ACP - 00858703006337

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

  • 00858703006337 ()


  • Bioelectrical signal analysis software

AMBCO - 00851195007011

Audiometer - Model 650AB
AMBCO ELECTRONICS
650AB
In Commercial Distribution

  • 00851195007011 ()
650AB

  • Tone audiometer

AMBCO - 00851195007004

AMBCO Audiometer - Model 650A
AMBCO ELECTRONICS
650A
In Commercial Distribution

  • 00851195007004 ()
650A

  • Tone audiometer

hearX - 00860003469811

No Description
HEARX GROUP (PTY) LTD
hearTest
In Commercial Distribution

  • 00860003469811 ()


  • Tone audiometer

Interacoustics - 05711117180565

No Description
Interacoustics A/S
EyeSeeCam
In Commercial Distribution

  • 05711117180565 ()


  • Eye movement analysis system

Interacoustics - 05711117180305

No Description
Interacoustics A/S
PA5
In Commercial Distribution

  • 05711117180305 ()


  • Tone audiometer
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