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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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Bio30+ System Physio HR - 05056336800260

Ion exchange chromatography column sold with lithium high resolution column, LED monitor, computer, autosampler and Openlab software.
BIOCHROM LIMITED
80-6000-56
In Commercial Distribution

  • 05056336800260 ()


  • Amino acid analyser IVD

Bio30+ System Physio HP - 05056336800222

Ion exchange chromatography analyzer sold with lithium high performance column, LED monitor, computer, autosampler and Openlab software.
BIOCHROM LIMITED
80-6000-53
In Commercial Distribution

  • 05056336800222 ()


  • Amino acid analyser IVD

CathCheck Disposable Kit - 00618874610036

CathCheck Disposable Kit box of 10 units to be used with CompuFlo Epidural Computer Controlled Anesthesia System
Milestone Scientific Inc.
EPI-6100-03
In Commercial Distribution

  • 00618874610036 ()


  • Epidural anaesthesia set, non-medicated

Access Point V2C - 00850067173021

Access Point V2C is an accessory that enables wireless streaming to a computer for the Opal V2C.
APDM WEARABLE TECHNOLOGIES, INC.
AP
In Commercial Distribution

  • 00850067173021 ()


  • Kinesiology ambulatory recorder

Welch Allyn, Inc. - 00732094070729

Welch Allyn PCH-100 Holter Office Software Kit including HR-100 Holter Recorder, 7-Lead AHA Cable, Laptop Computer, Printer
WELCH ALLYN, INC.
901052
Not in Commercial Distribution

  • 00732094070729 ()
100711

  • Electrocardiograph, professional, multichannel

Welch Allyn, Inc. - 00732094070705

Welch Allyn PCH-200 Holter Expert Software Kit including HR-300 Holter Recorder, 7-Lead AHA Cable, Laptop Computer, Printer
WELCH ALLYN, INC.
901052
Not in Commercial Distribution

  • 00732094070705 ()
100713

  • Electrocardiograph, professional, multichannel

Access Point V2C - B628APV2C0

APDM’s Access Point is an accessory that enables wireless streaming to a computer for the Opal V2C.
APDM, INC.
V2C
In Commercial Distribution

  • B628APV2C0 ()
APV2C

  • Kinesiology ambulatory recorder

BriefCase - 07290018052037

BriefCase is a radiological computer aided triage and notification software device. Software version 3.0.0 for CSF triage
AIDOC MEDICAL LTD
3.0.0
Not in Commercial Distribution

  • 07290018052037 ()


  • Radiology DICOM image processing application software

BriefCase - 07290018052020

BriefCase is a radiological computer aided triage and notification software device. Software version 2.0.0 for PE triage
AIDOC MEDICAL LTD
2.0.0
Not in Commercial Distribution

  • 07290018052020 ()


  • Radiology DICOM image processing application software

BriefCase - 07290018052013

BriefCase is a radiological computer aided triage and notification software device. Software version 1.1.0.0 for ICH triage.
AIDOC MEDICAL LTD
1.1.0.0
Not in Commercial Distribution

  • 07290018052013 ()


  • Radiology DICOM image processing application software

OrthAlign Plus - 00858704006558

HipAlign Instrument Tray Base
Orthalign, Inc.
403008-01
In Commercial Distribution

  • 00858704006558 ()
403008-01

  • Robotic surgical arm system
  • Orthopaedic surgical procedure kit, non-medicated, reusable

UbiqVue - B353UA2550C1

Active Monitoring Portal
Lifesignals, Inc.
UA2550-C
In Commercial Distribution

  • B353UA2550C1 ()


  • Wireless patient monitor/sensor reporting software, professional-only
  • Wearable multiple vital physiological parameter monitor

Kinesis Balance - 05391542950027

Kinesis Balance is a smartphone application for assessment of balance and falls risk in older adults. The product is software based and uses simple clinical questionnaires and the sensors embedded in a smartphone to measure balance and assess risk of falls. The application is intended to be used by older adults and their carers in the home.
KINESIS
2.0.1
In Commercial Distribution

  • 05391542950027 ()


  • Posturography system application software

Assess Balance - 00860010129111

No Description
Balance Tracking Systems Incorporated
Version 7
In Commercial Distribution

  • 00860010129111 ()


  • Posturography system application software

FTM-EVAL-AA - 03760349820062

FeetMe Evaluation mobileAndroid application version 3.Y.Z.
FEETME
3
In Commercial Distribution

  • 03760349820062 ()


  • Posturography system application software

FractureDetect (FX) - 00852491008016

FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device to assist clinicians in detecting fractures during the review of radiographs of the musculoskeletal system. FX is indicated for adults only.
Imagen Technologies, Inc.
1.0.0
In Commercial Distribution

  • 00852491008016 ()


  • X-ray image interpretive software

icobrain aria - B621ICOBRAINARIA1X1Y0

icobrain aria is a computer-assisted detection (CADe) and diagnosis (CADx) software device to be used as a concurrent reading aid to help trained radiologists in the detection, assessment and characterization of Amyloid Related Imaging Abnormalities (ARIA) from a set of brain MR images. The software provides information about the presence, location, size, severity and changes of ARIA-E (brain edema or sulcal effusions) and ARIA-H (hemosiderin deposition, including microhemorrhage and superficial siderosis). Patient management decisions should not be made solely on the basis of analysis by icobrain aria
icometrix NV
1.1
In Commercial Distribution

  • B621ICOBRAINARIA1X1Y0 ()


  • Radiology DICOM image processing application software

CNAP® Monitor 500 HD - 09120073933027

Main Unit;
CNSystems Medizintechnik GmbH
V1.5
In Commercial Distribution

  • 09120073933027 ()
21-FHCN-15544

  • Patient monitoring system module, blood pressure, noninvasive

CNAP® Monitor 500 HD - 09120073932990

Main Unit;
CNSystems Medizintechnik GmbH
V1.5
In Commercial Distribution

  • 09120073932990 ()
21-FHCN-15544

  • Patient monitoring system module, blood pressure, noninvasive

CNAP® Monitor 500 HD - 09120073932266

Main Unit;
CNSystems Medizintechnik GmbH
V1.5
In Commercial Distribution

  • 09120073932266 ()
21-FHCN-15544

  • Patient monitoring system module, blood pressure, noninvasive

CNAP® Monitor 500 HD - 09120073932242

Main Unit; including Quick Guide
CNSystems Medizintechnik GmbH
V1.5
In Commercial Distribution

  • 09120073932242 ()
21-FHCN-15544

  • Patient monitoring system module, blood pressure, noninvasive

Critical Care Suite - 00195278789365

Critical Care Suite 2.1, Designated Medical Device
GE MEDICAL SYSTEMS, INC.
2.1
In Commercial Distribution

  • 00195278789365 ()


  • X-ray image interpretive software

Rayvolve - 03770018071084

Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult and pediatric population (2 years and over).
AZMED
4
In Commercial Distribution

  • 03770018071084 ()


  • X-ray image interpretive software

Rayvolve - 03770018071077

Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult and pediatric population (2 years and over). (Variant : Full Cloud)
AZMED
4
In Commercial Distribution

  • 03770018071077 ()


  • X-ray image interpretive software

Rayvolve - 03770018071022

Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult only. Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types. (Variant : Cloud/VM)
AZMED
2
In Commercial Distribution

  • 03770018071022 ()


  • X-ray image interpretive software

Rayvolve - 03770018071015

Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult only. Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types. (Variant : Full Cloud)
AZMED
2
In Commercial Distribution

  • 03770018071015 ()


  • X-ray image interpretive software

Rayvolve - 03770018071008

Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult only. Rayvolve is indicated for radiographs of the following industry-standard radiographic views and study types. (Variant : On premise)
AZMED
2
In Commercial Distribution

  • 03770018071008 ()


  • X-ray image interpretive software

TechCare Trauma - 03770024774047

No Description
MILVUE
V1.1.x
In Commercial Distribution

  • 03770024774047 ()


  • Radiological PACS software

BoneView - 03770020839085

No Description
GLEAMER
1.1.X
In Commercial Distribution

  • 03770020839085 ()


  • Radiological PACS software

BoneView - 03770020839009

No Description
GLEAMER
1.X-US
In Commercial Distribution

  • 03770020839009 ()


  • Radiological PACS software

Rayvolve - 03770018071060

Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system. Rayvolve is indicated for adult and pediatric population (2 years and over). (Variant : VM + Cloud)
AZMED
4
In Commercial Distribution

  • 03770018071060 ()


  • X-ray image interpretive software

CLAB II Plus Amplifier - 00840682119634

ASSY CLABII PLUS64 AMP 110-240V 50/60HZ, AM 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
64 Channel
Not in Commercial Distribution

  • 00840682119634 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

CLAB II Plus Amplifier - 00840682119603

ASSY CLABII PLUS128 AMP 110-240V 50/60HZ, AM 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
128 Channel
In Commercial Distribution

  • 00840682119603 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

Pathfinder - 10841522125645

PATHFINDER SL/SENTINEL 10 EVAL SYSTEM (ENG)
SPACELABS HEALTHCARE (WASHINGTON), INC
98000, 98200
Not in Commercial Distribution

  • 10841522125645 ()
040-1726-01

  • Electrocardiographic long-term ambulatory recording analyser
  • Cardiology information system application software

Pathfinder - 10841522124563

PATHFINDER SL/SENTINEL 10 EVAL SYSTEM (ENG)
SPACELABS HEALTHCARE (WASHINGTON), INC
98000, 98200
Not in Commercial Distribution

  • 10841522124563 ()
040-1726-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser

Sentinel - 10841522123269

SENTINEL 10.0.1 STANDALONE WORKSTAT LICENCE EN
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522123269 ()
040-1702-00

  • Cardiology information system application software

Sentinel - 10841522123252

SENTINEL 10.0.1 OFFLINE/NETWORK WORKSTAT EN
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522123252 ()
040-1705-00

  • Cardiology information system application software

Sentinel - 10841522123245

SENTINEL 10.0.1 NETWORK WORKSTATION LICENSE EN
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522123245 ()
040-1703-00

  • Cardiology information system application software

Sentinel - 10841522123238

SENTINEL 10.0.1 ADD. NETWORK WORKSTAT LICENSE EN
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522123238 ()
040-1704-00

  • Cardiology information system application software

SENTINEL - 10841522123221

SENTINEL 10 WORKSTATION (X1) + 4 WEB LICENSES
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522123221 ()
040-1713-00

  • Cardiology information system application software

Sentinel - 10841522103452

Cardiology Information Management System
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103452 ()
10.0.1

  • Cardiac stress exercise monitoring system

PathfinderSL - 10841522103131

SENTINEL 10 WORKSTATION (X1) + 4 WEB LICENSES
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103131 ()
040-1713-00

  • Cardiology information system application software

SENTINEL - 10841522103124

SENTINEL 10 WORKSTATION (X10) + ABP LICENSE
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103124 ()
040-1712-00

  • Cardiology information system application software

Sentinel - 10841522103117

SENTINEL 10 WORKSTATION (X5) + ABP LICENSE
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103117 ()
040-1711-00

  • Cardiology information system application software

Sentinel - 10841522103100

SENTINEL 10 WORKSTATION (X2) + ABP LICENSE
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103100 ()
040-1710-00

  • Cardiology information system application software

Sentinel - 10841522103094

SENTINEL 10 WORKSTATION (X1) + ABP LICENSE
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103094 ()
040-1709-00

  • Cardiology information system application software

SphygmoCor - 19351315000017

Packaged SphygmoCor CVMS systems including assembly module EM3 with UDI Direct Marking plus various components [SphygmoCor CVMS software CD, tonometer, power cord/adapter, ECG pads/leads/cables (CPV configuration only), footswitch, and others]. CONFIGURATIONS ENCOMPASSED BY THE CVMS VERSION/MODEL: • CvMS-CP Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) only]. • CvMS-CPV Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) and pulse wave velocity (PWV)] • CvMS-CPVH Configuration: [SphygmoCor software configured for pulse wave analysis (PWA), pulse wave velocity (PWV) and Heart Rate Variability (HRV)].
ATCOR MEDICAL PTY LTD
CVMS
In Commercial Distribution

  • 19351315000017 ()
  • 19351315000024 ()


  • Patient monitoring system module, multifunction

Endowrist SP - 00886874122228

CAMERA, 0°
INTUITIVE SURGICAL, INC.
430077
In Commercial Distribution

  • 00886874122228 ()

  • Outer Diameter: 6 Millimeter


  • Rigid optical laparoscope

Earlens Wireless Programmer - 00850013007110

Software version is in Application Identifier (8012) Lot Number reflects software assembly/packaging lot number
EARLENS CORPORATION
WPUSB01
Not in Commercial Distribution

  • 00850013007110 ()
WPUSB01

  • Hearing aid/implant system programming interface unit

Harmony - 00850003069593

Harmony 6.2 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
6.2
In Commercial Distribution

  • 00850003069593 ()


  • Camera application software
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