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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Local version of TrakStar Patient Data Management System Software
NEURONETICS, INC.
Version 7.6 (Local)
In Commercial Distribution

  • 00850005944102 ()
83-00056-000

  • Magnetic neural stimulation system
Local version of TrakStar Patient Data Management System Software
NEURONETICS, INC.
Version 7.5 (Local)
In Commercial Distribution

  • 00850005944096 ()
83-00056-000

  • Magnetic neural stimulation system
Natus Elite v2 Software Upgrade with New System Order
NATUS NEUROLOGY INCORPORATED
688-630200
In Commercial Distribution

  • 00382830062251 ()


  • Electromyograph
EMG v20/v21 to Natus Elite v2 Software Upgrade
NATUS NEUROLOGY INCORPORATED
688-630400
In Commercial Distribution

  • 00382830045087 ()


  • Electromyograph
Care Orchestrator Essence, Medical equipment clinical data interfacing software
Respironics, Inc.
4.0.0
In Commercial Distribution

  • 00606959062863 ()
1135709

  • Medical equipment clinical data interfacing software
Task Force® Monitor software incl. customer CD (multilingual)
CNSystems Medizintechnik GmbH
V2.3
In Commercial Distribution

  • 09120073931931 ()
FHCS3043

  • General-purpose multi-parameter bedside monitor
Software, Sonicare Power Tooth brush, Web download App Android
PHILIPS ORAL HEALTHCARE, LLC
HX9999/99
In Commercial Distribution

  • 08710103988984 ()


  • Basic electric toothbrush
Software, Sonicare Power Tooth brush, Web download App iOS
PHILIPS ORAL HEALTHCARE, LLC
HX9999/99
In Commercial Distribution

  • 08710103988977 ()


  • Basic electric toothbrush
Radiological visualization software for diagnosis and dental treatment planning
SiCAT GmbH & Co. KG
6455641
Not in Commercial Distribution

  • D77664556410 ()
6455641

  • Diagnostic x-ray digital imaging system workstation
Software Module (RoHS Compliant) RITA Model 1500X RF Generator
ANGIODYNAMICS, INC.
700-105937
In Commercial Distribution

  • H7877001059370 ()
  • 15051684025867 ()


  • Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar
Japanese Software Module for RITA Model 1500X RF Generator
ANGIODYNAMICS, INC.
700-105740
Not in Commercial Distribution

  • H7877001057400 ()
  • 15051684026253 ()


  • Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar
BD Pyxis MedBank Tower (Cabinet CR Software v3.X)
CAREFUSION 303, INC.
SW-MB-CR-V3
In Commercial Distribution

  • 10885403513800 ()


  • Anaesthesia cabinet
Large Volume Pump (LVP) Software (order 1 per pump)
Fresenius Kabi AG
030-0028-06
Not in Commercial Distribution

  • 00811050530375 ()
LVP-SW

  • Bedside infusion pump, single-channel
Large Volume Pump (LVP) Software (order 1 per pump)
Fresenius Kabi AG
030-0028-08
In Commercial Distribution

  • 00811505030467 ()
LVP-SW

  • Bedside infusion pump, single-channel
Large Volume Pump (LVP) Software (order 1 per pump)
Fresenius Kabi AG
030-0028-07
In Commercial Distribution

  • 00811505030436 ()
LVP-SW

  • Bedside infusion pump, single-channel
Large Volume Pump (LVP) Software (order 1 per pump)
Fresenius Kabi AG
030-0028-06
In Commercial Distribution

  • 00811505030375 ()
LVP-SW

  • Bedside infusion pump, single-channel
Synergy E Host Software for SmartMonitor 2 Product Line
CIRCADIANCE, LLC
101483
In Commercial Distribution

  • B036101483 ()
101483

  • Infant apnoea monitor
EZ™ Software CD & Data Cable for ECG Monitor
VASOMEDICAL, INC.
Model EZ
In Commercial Distribution

  • 00817980021396 ()
A13-0040

  • Electrocardiographic long-term ambulatory recording analyser application software
ARCS Analysis & Reporting Software Dongle Only, 12 Channel ECG
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020221 ()
A10-0118-12

  • Electrocardiographic long-term ambulatory recording analyser application software
ARCS Analysis & Reporting Software & Dongle, 3 Channel ECG, USB
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020177 ()
A10-0118-00

  • Electrocardiographic long-term ambulatory recording analyser application software
CB Series Analysis & Reporting Software - 3 & 12 CH ECG
VASOMEDICAL, INC.
CB Series S/W
In Commercial Distribution

  • 00817980020139 ()
A10-0031

  • Electrocardiographic long-term ambulatory recording analyser application software
ARCS Analysis & Reporting Software & Dongle, 12 Channel ECG, USB
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020214 ()
A10-0118-10

  • Electrocardiographic long-term ambulatory recording analyser application software
ARCS Analysis & Reporting Software Dongle Only, 3 Channel ECG
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020207 ()
A10-0118-02

  • Electrocardiographic long-term ambulatory recording analyser application software
Application- Bio-Impendence Analysis software used for determining Body Composition
IMPEDIMED LIMITED
1.1.0
Not in Commercial Distribution

  • B277SOZOPRO0 ()
SOZOpro

  • Bioelectrical body composition analyser
Sherlock 3GC Diamond TCS on Site~Rite 8 Software
Bard Access Systems, Inc.
Sherlockv1.1.2
In Commercial Distribution

  • 00801741121470 ()
Sherlockv1.1.2

  • Central venous catheter navigation system, electrocardiographic/magnetic
Software for MicronMapper and MicronMapper EVO Dental Metrology Systems
Claronav Inc
990-MM1-INST-WIN
In Commercial Distribution

  • 07540209956232 ()


  • Dental milling system, CAD/CAM, laboratory
Stellaris Elite PC with Laser with Version 5+ Software
Bausch & Lomb Incorporated
BL15455
In Commercial Distribution

  • 00757770524532 ()
BL15455

  • Phacoemulsification/vitrectomy system
Stellairs Elite PC Combined System with Version 5+ Software
Bausch & Lomb Incorporated
BL14455
In Commercial Distribution

  • 00757770524525 ()
BL14455

  • Phacoemulsification/vitrectomy system
Software, TomoApps, Version 2.1.1, Build # 5.1.1 (Operating Software for TomoTherapy systems, including TomoH®, TomoHD®, TomoHDA™ and Onrad™)
ACCURAY INCORPORATED
1048968
In Commercial Distribution

  • M65810489680 ()
N/A

  • Linear accelerator system
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - ECG Management System NEMS, Cloud Access to NEMS-Q The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NEMS-CL
In Commercial Distribution

  • 07290110252540 ()
HASP-SW-K-NEMS-CL-01

  • Patient-administration information system application software
The RS-232 Interface Module provides the interface between the RS-232 protocol data acquistion software and the system. The module outputs system data to the data acquisition software such as Tlink Data management Software.
Terumo Cardiovascular Systems Corporation
802113
In Commercial Distribution

  • 00886799000731 ()
802113

  • Cardiopulmonary bypass system, roller type
No Description
ULTROMICS LIMITED
Amyloidosis 1.0
In Commercial Distribution

  • 05060634690065 ()


  • Radiology DICOM image processing application software
  • Cardiac mapping system application software
  • Ultrasound imaging system application software
No Description
ULTROMICS LIMITED
Heart Failure 2.0
In Commercial Distribution

  • 05060634690058 ()


  • Radiology DICOM image processing application software
  • Cardiac mapping system application software
  • Ultrasound imaging system application software
No Description
ULTROMICS LIMITED
Heart Failure 1.0
In Commercial Distribution

  • 05060634690041 ()


  • Radiology DICOM image processing application software
  • Cardiac mapping system application software
  • Ultrasound imaging system application software
No Description
ULTROMICS LIMITED
Pro
In Commercial Distribution

  • 05060634690010 ()


  • Ultrasound imaging system application software
  • Cardiac mapping system application software
No Description
SRS Medical Systems, Inc.
900-026
In Commercial Distribution

  • 00890477000180 ()


  • Kinesiology/electromyographic sensor set
  • Biofeedback system application software
  • Electromyograph
No Description
SRS Medical Systems, Inc.
900-037
In Commercial Distribution

  • 00890477000098 ()


  • Kinesiology/electromyographic sensor set
  • Biofeedback system application software
  • Electromyograph
The device is intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging of the human body and provides measurements of shear wave speed and tissue stiffness, ultrasound tissue brightness parameters such as ultrasound beam attenuation and backscattering coefficient, and estimates of speed of sound, in internal structures of the body. The device is intended to be used by trained healthcare professionals, in a healthcare environment. The device is indicated for imaging of anatomical structures in the abdomen and measurements of physical properties in the liver and the spleen. In particular, the device is intended to provide: Linear distance measurements of anatomical structures, Measurement of shear wave speed at selected shear wave frequencies, and estimates of tissue stiffness in the liver and the spleen, Estimates of ultrasound tissue brightness parameters in the liver at selected ultrasound frequencies, Measurement of brightness ratio between structures and in particular between the liver and the kidney, Estimates of speed of sound in the liver. The shear wave speed measurements, ultrasound tissue brightness parameters, elastic properties estimates, brightness ratio may be used as an aid to the diagnosis, monitoring and clinical management of adult and pediatric patients with liver disease.
E-SCOPICS
V2
In Commercial Distribution

  • 03770023859011 ()


  • Ultrasound imaging system application software
  • Hepatic ultrasound elastography system
VANTAGEVIEW 2.0 ENCODER HD
Barco NV
MNA-420
In Commercial Distribution

  • 05415334053670 ()
600306027

  • Operating room audiovisual data/device management system
VANTAGEVIEW 2.0 DECODER
Barco NV
MNA-240
In Commercial Distribution

  • 05415334053663 ()
600301482

  • Operating room audiovisual data/device management system
VANTAGEVIEW 2.0 ANALOG ENCODER
Barco NV
MNA-120
In Commercial Distribution

  • 05415334053472 ()
600301481

  • Operating room audiovisual data/device management system
VANTAGEVIEW 2.0 ENCODER 4K
Barco NV
MNA-440
In Commercial Distribution

  • 05415334053458 ()
600301479

  • Operating room audiovisual data/device management system
MNA-420 DEC HDMI V2
Barco NV
MNA-420
In Commercial Distribution

  • 05415334050839 ()
K9303331CMS

  • Operating room audiovisual data/device management system
MNA-440 DEC HDMI V2
Barco NV
MNA-440
In Commercial Distribution

  • 05415334050822 ()
K9303311CMS

  • Operating room audiovisual data/device management system
MNA-420 ENC HDMI
Barco NV
MNA-420
In Commercial Distribution

  • 05415334050815 ()
K9303320CMS

  • Operating room audiovisual data/device management system
NEXXIS WORKSPOT KIT2 CM
Barco NV
Nexxis system
In Commercial Distribution

  • 05415334042346 ()
K9610424

  • Operating room audiovisual data/device management system
NEXXIS SYSTEM X670 CM V6
Barco NV
NEXXIS system
In Commercial Distribution

  • 05415334039131 ()
k9605033

  • Operating room audiovisual data/device management system
NEXXIS SYSTEM X620 CM V6
Barco NV
NEXXIS system
In Commercial Distribution

  • 05415334039124 ()
k9605034

  • Operating room audiovisual data/device management system
MNA-440 ENC SDI IN
Barco NV
MNA-440
In Commercial Distribution

  • 05415334037687 ()
k9303301D

  • Operating room audiovisual data/device management system
MNA-420 ENC HDMI IN
Barco NV
MNA-420
In Commercial Distribution

  • 05415334037632 ()
k9303320D

  • Operating room audiovisual data/device management system
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