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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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A comprehensive analysis suite for magnetoencephalographic and electroencephalographic data acquired with Elekta Neuromag®, Elekta Neuromag® TRIUX and TRIUX™ neo.
Megin Oy
SW23380N
In Commercial Distribution

  • 06430056480022 ()


  • Electroencephalograph
No Description
Philips Ultrasound LLC
989605496481
In Commercial Distribution

  • 00884838091672 ()


  • Radiological PACS software
No Description
Philips Ultrasound LLC
989605492681
In Commercial Distribution

  • 00884838090736 ()


  • Radiological PACS software
No Description
Philips Ultrasound LLC
989605465051
In Commercial Distribution

  • 00884838084322 ()


  • Radiological PACS software
Guideline 4000™ Resident Expert Software Module, 1x
FHC, INC.
C0258-00818
In Commercial Distribution

  • 00873263008188 ()
C0258

  • Neurophysiologic monitoring system
Guideline 4000™ Resident Expert Software Module, 1x
FHC, INC.
C0258-00808
Not in Commercial Distribution

  • 00873263008089 ()
C0258

  • Neurological stereotactic surgery system
VMA Image Acquisition Software (SW1) installed on VMA (Motion Normalizer Console)
ORTHO KINEMATICS, INC.
3
In Commercial Distribution

  • 00868579000230 ()


  • Radiological PACS software
No Description
ZOLL MANUFACTURING CORPORATION
Version 1.0
In Commercial Distribution

  • 00855778005333 ()


  • Electrocardiograph, professional, multichannel
The ScottCare VersaCare Cardiopulmonary Monitoring System is designed to allow monitoring and recording of electrocardiograph (ECG) rhythm strips and related information for patients undergoing an exercise therapy program. Patients are monitored by medical telemetry exercise monitoring equipment. This feature allows patients to comply with exercise prescriptions while exercising at a medical/rehabilitation facility near their home, or by returning to the primary medical facility to participate in an in-house cardiopulmonary rehabilitation program. VersaCare includes a Program Management module that prints a variety of reports.
SCOTTCARE CORPORATION, THE
TeleRehab Software File Manager
In Commercial Distribution

  • 00856298006244 ()
101601

  • Electrocardiography telemetric monitoring system
User interface in the patient's room
Vital Connect, Inc.
6100-03
In Commercial Distribution

  • 00850490007382 ()
6100-03

  • Electrocardiography telemetric monitoring system
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