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Visura TEECAD Carrier Control Unit
VISURA TECHNOLOGIES, INC.
VS-V2
VIS0101
- Ultrasound imaging transducer positioning unit
Visura TEECAD Carrier
VISURA TECHNOLOGIES, INC.
CR-P2
VIS0100
- Ultrasound imaging transducer positioning unit
Endovenous Radiofrequency Ablation (RFA) Catheter 3-60
Vein360 LLC
VEN-3-60
VEN-3-60
- Radio-frequency ablation system
Endovenous Radiofrequency Ablation (RFA) Catheter 7-60
Vein360 LLC
VEN-7-60
VEN-7-60
- Radio-frequency ablation system
COVID-19 antigen self home test in vitro diagnostic use only (5 Test Kits/Box)
BIOTEKE USA, LLC
BTK-H2205
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
COVID-19 antigen self home test in vitro diagnostic use only (2 Test Kits/Box)
BIOTEKE USA, LLC
BTK-H2202
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
COVID-19 antigen self home test in vitro diagnostic use only (1 Test Kit/Box)
BIOTEKE USA, LLC
BTK-H2201
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Automated tissue sectioning and transfer system
Clarapath, Inc.
810-00001
- Rotary microtome IVD
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
Monitair LLC
1.3.x
- Vulnerable patient home-monitoring software, professional-only
MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
Monitair LLC
1.2.13
- Vulnerable patient home-monitoring software, professional-only