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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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hi Health Innovations - 00858177007076

Hearing Aid Fitting Software
INTRICON CORPORATION
hi-PS
In Commercial Distribution

  • 00858177007076 ()
22724

  • Hearing aid wireless-fitting computer-aided set

CloudCath Connect - Patient Monitoring Software - 00860006810238

Patient Monitoring Software/System
Gastroklenz Inc.
04PD001
In Commercial Distribution

  • 00860006810238 ()


  • Peritoneal dialysis system

Kinesia StimPoint - 00859584006195

Kinesia StimPoint Application Software
Great Lakes Neurotechnologies Inc.
360-0050 Kinesia StimPoint Software
In Commercial Distribution

  • 00859584006195 ()
360-0050

  • Tremor transducer

Kinesia 360 - 00859584006126

Kinesia 360, Application Software
Great Lakes Neurotechnologies Inc.
360-0041, Application Software
In Commercial Distribution

  • 00859584006126 ()


  • Tremor transducer

Kinesia One - 00859584006119

Kinesia One, Application Software
Great Lakes Neurotechnologies Inc.
360-0040, Application Software
In Commercial Distribution

  • 00859584006119 ()


  • Tremor transducer

HeartSee Cardiac PET Processing Software - 30815112021543

Cardiac PET Processing Software
Bracco Diagnostics Inc.
4
In Commercial Distribution

  • 30815112021543 ()
001771

  • Image segmentation application software

SPOTCHECK - 00725609000434

NeoPac Software with Manual
ASTORIA-PACIFIC, INC.
307-C001-00
In Commercial Distribution

  • 00725609000434 ()
307-C001-00

  • Laboratory instrument/analyser application software IVD

Welch Allyn, Inc. - 00732094319057

Software Rest Interp v7.5
WELCH ALLYN, INC.
901155
In Commercial Distribution

  • 00732094319057 ()
107440

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094326802

E-Scribe Oracle Database Software
WELCH ALLYN, INC.
901134
Not in Commercial Distribution

  • 00732094326802 ()
108086

  • Patient health record information system application software

Welch Allyn, Inc. - 00732094320800

XSCRIBE V6.3.0 SOFTWARE CD
WELCH ALLYN, INC.
901144
Not in Commercial Distribution

  • 00732094320800 ()
419540

  • Electrocardiographic lead set, reusable

Welch Allyn, Inc. - 00732094320794

Q-STRESS V6.3.0 SOFTWARE CD
WELCH ALLYN, INC.
901144
Not in Commercial Distribution

  • 00732094320794 ()
419449

  • Electrocardiographic lead set, reusable

Welch Allyn, Inc. - 00732094356878

DVD SOFTWARE HSCRIBE V6.4.1
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094356878 ()
109202

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094356861

DVD SOFTWARE VISION V6.4.1
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094356861 ()
109203

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094272468

SOFTWARE H-SCRIBE VER 4.34
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094272468 ()
11013-018-50

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094272437

SOFTWARE ASSY R-SCRIBE V1.10.10
WELCH ALLYN, INC.
901127
In Commercial Distribution

  • 00732094272437 ()
11017-002-50

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094272390

SOFTWARE SURVEYOR IMPORT V4.10
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094272390 ()
11054-009-50

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094272369

SOFTWARE X-SCRIBE HX-GATE V1.11
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094272369 ()
11064-003-51

  • Electrocardiographic lead set, reusable

Welch Allyn, Inc. - 00732094281385

SOFTWARE Q-STRESS & RSCRIBE V6.2.2
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094281385 ()
11107-005-50

  • Electrocardiographic lead set, reusable

Welch Allyn, Inc. - 00732094258905

SOFTWARE E-SCRIBE SERVER V8.15
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094258905 ()
11012-014-50

  • Patient health record information system application software

Implant Studio - 05902729753265

Dental treatment application software
3shape Medical A/S
2.17.3 (R1.2)
Not in Commercial Distribution

  • 05902729753265 ()


  • Dental treatment application software
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