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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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Lutech - B299750MI0

Multi-parameter patient monitor. 750-M-I
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750MI0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750MCP0

Multi-parameter patient monitor. 750-M-C-P
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750MCP0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750MC0

Multi-parameter patient monitor. 750-M-C
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750MC0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750M0

Multi-parameter patient monitor. 750-M
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750M0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750LP0

Multi-parameter patient monitor. 750-L-P.
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750LP0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750LIP0

Multi-parameter patient monitor. 750-L-I-P
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750LIP0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750LICP0

Multi-parameter patient monitor. 750-L-IC-P
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750LICP0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750LIC0

Multi-parameter patient monitor. 750-L-IC
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750LIC0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750LI0

Multi-parameter patient monitor. 750-L-I
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750LI0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750LCP0

Multi-parameter patient monitor. 750-L-C-P
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750LCP0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750LC0

Multi-parameter patient monitor. 750-L-C
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750LC0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750L0

Multi-parameter patient monitor. 750-L
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750L0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Amimon - 00817157020825

No Description
AMIMON LTD
MD52 Rx - MDWL2_B3P1RX
In Commercial Distribution

  • 00817157020825 ()


  • Medical image management system

Amimon - 00817157020818

No Description
AMIMON LTD
MD52 Tx - MDWL2_B1P1TX
In Commercial Distribution

  • 00817157020818 ()


  • Medical image management system

Amimon - 00817157020771

No Description
AMIMON LTD
MD11 System - MDWL1_B1N1RX
In Commercial Distribution

  • 00817157020771 ()


  • Medical image management system

Amimon - 00817157020764

No Description
AMIMON LTD
MD11 System - MDWL1_C1N1TX
In Commercial Distribution

  • 00817157020764 ()


  • Medical image management system

Amimon - 00817157020757

No Description
AMIMON LTD
MD62 System - MDWL2_B1J1RX
In Commercial Distribution

  • 00817157020757 ()


  • Medical image management system

Amimon - 00817157020740

No Description
AMIMON LTD
MD62 System - MDWL2_B1J1TX
In Commercial Distribution

  • 00817157020740 ()


  • Medical image management system

EyeSuite Software - 07640132986105

No Description
Haag-Streit AG
i8.2
In Commercial Distribution

  • 07640132986105 ()


  • Medical image management system

EyeSuite Software - 07640132987256

No Description
Haag-Streit AG
i9.0
In Commercial Distribution

  • 07640132987256 ()


  • Medical image management system

Omni™ Surgical Suite - 00889024624887

No Description
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
AI1019
In Commercial Distribution

  • 00889024624887 ()
AI1019

  • Medical image management system

Omni™ Surgical Suite Platform - 00889024596184

No Description
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
AI1000
In Commercial Distribution

  • 00889024596184 ()
AI1000

  • Medical image management system

Arthrex® - 00888867226975

Synergy.Net HL7 Software Single License
ARTHREX, INC.
AR-3200-1047
In Commercial Distribution

  • 00888867226975 ()
AR-3200-1047

  • Medical image management system

Arthrex® - 00888867200319

Synergy.Net Text Notification License K
ARTHREX, INC.
AR-3200-1046
In Commercial Distribution

  • 00888867200319 ()
AR-3200-1046

  • Medical image management system

Arthrex® - 00888867200302

Synergy.Net Reporting License Key
ARTHREX, INC.
AR-3200-1045
In Commercial Distribution

  • 00888867200302 ()
AR-3200-1045

  • Medical image management system

Arthrex® - 00888867200296

Synergy.Net OR Command License Key
ARTHREX, INC.
AR-3200-1044
In Commercial Distribution

  • 00888867200296 ()
AR-3200-1044

  • Medical image management system

Arthrex® - 00888867200289

Synergy.net Printing License Key
ARTHREX, INC.
AR-3200-1043
In Commercial Distribution

  • 00888867200289 ()
AR-3200-1043

  • Medical image management system

Criticare - B438560DNUS0

Monitor with DOX SPO2, NIBP, and HR
CRITICARE TECHNOLOGIES, INC.
eQuality 506DN
In Commercial Distribution

  • B438560DNUS0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Criticare Gemini - B438506LNVP30

Monitor with Nellcor SPO2, NIBP, HR, Temp, and Printer
CRITICARE TECHNOLOGIES, INC.
VitalCare 506LNVP3
In Commercial Distribution

  • B438506LNVP30 ()


  • Multiple vital physiological parameter monitoring system, clinical

Criticare Gemini - B438506LNP30

Monitor with Nellcor SPO2, NIBP, HR, and Printer
CRITICARE TECHNOLOGIES, INC.
VitalCare 506LNP3
In Commercial Distribution

  • B438506LNP30 ()


  • Multiple vital physiological parameter monitoring system, clinical

Criticare Gemini - B438506DNVP30

Monitor with DOX SPO2, NIBP, HR, Printer and Temp
CRITICARE TECHNOLOGIES, INC.
VitalCare 506DNVP3
In Commercial Distribution

  • B438506DNVP30 ()


  • Multiple vital physiological parameter monitoring system, clinical

Criticare Gemini - B438506DNP3US0

Monitor with DOX SPO2, NIBP, HR, and Printer
CRITICARE TECHNOLOGIES, INC.
VitalCare 506DNP3
In Commercial Distribution

  • B438506DNP3US0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Arthrex® - 00888867261648

Synergy Matrix Management SW Addtnl Lic
ARTHREX, INC.
AR-3200-1049
In Commercial Distribution

  • 00888867261648 ()
AR-3200-1049

  • Medical image management system

Arthrex® - 00888867387928

BioOptico Spectral Mode Key Kit
ARTHREX, INC.
AR-3200-1026
In Commercial Distribution

  • 00888867387928 ()
AR-3200-1026

  • Medical image management system

LiverMultiScan - B554LMS2000

LiverMultiScan is a standalone software device. The purpose of the LiverMultiScan device is to assist the trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (patient visit). A trained operator places circular regions of interest drawn upon previously acquired MR images, from which a summary report is generated. The summary report is sent to an interpreting clinician. LiverMultiScan does not replace the usual procedures for assessment of the liver by an interpreting clinician, providing many opportunities for competent human intervention in the interpretation of images and information displayed. The metrics are intended to be used as an additional diagnostic input to provide information to clinicians as part of a wider diagnostic process. It is expected that in the normal course of liver disease diagnosis, patients will present with clinical symptoms or risk factors which may indicate liver disease. Liver function tests, blood tests, ultrasound scanning as well as liver biopsy are all expected to be used at the discretion of a qualified clinician in addition to information obtained from the use of LiverMultiScan metrics. The purpose of LiverMultiScan metrics are to provide imaging information to assist in characterising tissue in the liver, which is additional to existing methods for obtaining information relating to the liver. LiverMultiScan metrics do not replace any existing diagnostic source of information, but can be used to identify patients who may benefit most from further evaluation, including biopsy. Information gathered through existing diagnostic tests and clinical evaluation of the patient, as well as information obtained from LiverMultiScan metrics, may contribute to a diagnostic decision.
PERSPECTUM LTD
2.0
In Commercial Distribution

  • B554LMS2000 ()


  • MRI system application software

Surveyor S19 - 00817655022734

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR19-UAA-XXXAX
Not in Commercial Distribution

  • 00817655022734 ()


  • Centralized patient monitor

Surveyor S19 - 00817655022727

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR19-TAA-XXXAX
Not in Commercial Distribution

  • 00817655022727 ()


  • Centralized patient monitor

Surveyor S19 - 00817655022710

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR19-FAA-XXXAX
Not in Commercial Distribution

  • 00817655022710 ()


  • Centralized patient monitor

Sleepiz One+ - 07649996477019

No Description
Sleepiz AG
1.0
In Commercial Distribution

  • 07649996477019 ()


  • Multiple vital physiological parameter monitoring system, home-use

Surveyor Central - 00817655022550

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCNODE-AAA-AOBEX
Not in Commercial Distribution

  • 00817655022550 ()


  • Centralized patient monitor

Surveyor Central - 00817655022147

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCNODE-DAA-BXXEX
Not in Commercial Distribution

  • 00817655022147 ()


  • Centralized patient monitor

Surveyor S19 - 00817655022017

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR19-SAA-XXXAX
Not in Commercial Distribution

  • 00817655022017 ()


  • Centralized patient monitor

Surveyor Central - 00817655021942

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCSYS-HAE-SHFCX
Not in Commercial Distribution

  • 00817655021942 ()


  • Centralized patient monitor

Surveyor S19 - 00817655021928

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR19-LAA-XXXAX
Not in Commercial Distribution

  • 00817655021928 ()


  • Centralized patient monitor

Surveyor Central - 00817655021065

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCNODE-BAA-AKXEX
Not in Commercial Distribution

  • 00817655021065 ()


  • Centralized patient monitor

Surveyor S19 - 00817655021027

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR19-DAA-XXAAX
Not in Commercial Distribution

  • 00817655021027 ()


  • Centralized patient monitor

Surveyor Central - 00817655021010

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCNODE-GAA-XXDEX
Not in Commercial Distribution

  • 00817655021010 ()


  • Centralized patient monitor

Surveyor Central - 00817655021003

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCNODE-BAA-EKXFX
Not in Commercial Distribution

  • 00817655021003 ()


  • Centralized patient monitor

Surveyor Central - 00817655020990

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCSYS-IAE-SDFCX
Not in Commercial Distribution

  • 00817655020990 ()


  • Centralized patient monitor

Surveyor Central - 00817655020983

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCNODE-DAA-CKXEX
Not in Commercial Distribution

  • 00817655020983 ()


  • Centralized patient monitor
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