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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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No Description
mediCAD Hectec GmbH
7
In Commercial Distribution

  • 04260489720110 ()


  • Orthopaedic/craniofacial implantation planning software
No Description
ICU MEDICAL, INC.
22-3510-51
In Commercial Distribution

  • 00610586032335 ()


  • Infusion pump medication-dosage application software
No Description
ICU MEDICAL, INC.
21-6143-01
In Commercial Distribution

  • 00610586019145 ()


  • Infusion pump medication-dosage application software
No Description
IRHYTHM TECHNOLOGIES, INC.
FG0401US
In Commercial Distribution

  • 00850043907046 ()


  • Cardiopulmonary physiological parameter analysis software
Digital image acquisition system designed to automate patient work flow that includes image processing algorithms for imaging.
VAREX IMAGING CORPORATION
v4.9
In Commercial Distribution

  • 00854344007658 ()


  • Angiographic x-ray system application software
ApolloHipX
CORIN LTD
THR.SS.0001
In Commercial Distribution

  • 05056139249501 ()


  • Robotic surgical system application software
No Description
SCOTTCARE CORPORATION, THE
EZLink-C
In Commercial Distribution

  • 00856298006435 ()
103200

  • Cardiology information system application software
No Description
SCOTTCARE CORPORATION, THE
EZLink-R
In Commercial Distribution

  • 00856298006428 ()
103201

  • Cardiology information system application software
ScottCare’s OneView is an innovative, cardiology software tool used to simplify and streamline the pacemaker/ICD monitoring session reporting process by consolidating all device manufacturers’ session data into one, convenient platform. With a click of a button, OneView captures all relevant pacemaker/ICD data, including:  Device specifications  Measurements for every session  Settings  Episode details  Reports  Physician sign-off OneView also provides insight into historical patient trends and other critical clinical data over time, helping to prioritize patients with more severe issues. In addition, data can be gathered from almost anywhere, as it supports remote interrogation, in-person interrogation and in-person programming.
SCOTTCARE CORPORATION, THE
OneView
In Commercial Distribution

  • 00856298006206 ()
101247

  • Cardiology information system application software
The EventCare Event Monitoring System allows for the performance of traditional acoustic arrhythmia monitoring and the utilization of cellular event transmissions and monitoring. The system helps to maintain an accurate inventory of devices, patients’ records ECG events and reports. The system can also produce a wide array of administrative reports to help manage your monitoring operations. This program provides fast, accurate access to your patients’ events and Electrocardiographic recordings, regardless of time or location. EventCare allows you to receive live or recorded ECG transmissions over ordinary telephone lines, as well as cellular telephony networks, edit the ECG right on the computer screen, then print out a detailed, professional report.
SCOTTCARE CORPORATION, THE
EventCare
In Commercial Distribution

  • 00856298006190 ()
100792

  • Cardiology information system application software
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