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Software medical device. Intended for use by professional healthcare providers as an intra-operative image-guidance tool used during surgical and interventional therapy.
Philips Medical Systems Nederland B.V.
ClarifEye - 1
In Commercial Distribution
- 00884838104570 ()
002120
- Stereotactic system application software
UroNAV Fusion Biopsy System
Philips DS North America LLC
784001
In Commercial Distribution
- 00884838083592 ()
- Stereotactic system application software
UroNAV Fusion Biopsy System
Philips DS North America LLC
784012
In Commercial Distribution
- 00884838081543 ()
- Stereotactic system application software
No Description
Edan Instruments, Inc.
MFM-CNS Lite
In Commercial Distribution
- 06944413807983 ()
- Obstetrical monitoring/analysis software
No Description
Edan Instruments, Inc.
CMS-1000FM
In Commercial Distribution
- 06944413806825 ()
- Obstetrical monitoring/analysis software
No Description
Edan Instruments, Inc.
MFM-CNS
In Commercial Distribution
- 06944413800236 ()
- Obstetrical monitoring/analysis software
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Android devices (various manufacturers).
ELI LILLY AND COMPANY
MA9131 Android
In Commercial Distribution
- 00300021109554 ()
MA9131001AM
- Medication reminder application software
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices.
ELI LILLY AND COMPANY
MA7723 IOS
In Commercial Distribution
- 00300021107550 ()
MA7723001AM
- Medication reminder application software
BeCareLink MS is a mobile medical application designed to assist individuals diagnosed with Multiple Sclerosis (MS) in tracking, assessing, and managing their condition. The application allows users to complete periodic assessments that measure various neurological functions, including cognitive processing, motor coordination, and speech. These assessments are designed to provide longitudinal data regarding disease progression and symptom variability. The app stores user responses and performance data, which can be reviewed by healthcare professionals to aid in clinical decision-making. The software does not provide a diagnosis or treatment recommendation but functions as a patient management and monitoring tool.
BeCare Link, LLC
MS 2.1
In Commercial Distribution
- 00199284085701 ()
BCL-MS
- Self-care monitoring/reporting software
Software as a Medical Device (SaMD) which operates as a medication reminder and support services; Operates on Android devices.
Astellas Pharma Us, Inc.
Android (Version 1)
In Commercial Distribution
- 00304692416447 ()
DIGI-002
- Medication reminder application software