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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Twister Button (300 mm) Blue
mo-Vis
P005-88
In Commercial Distribution

  • 05407008320263 ()


  • Assistive input-control operation training device, selection techniques
Twister Button (300 mm) Yellow
mo-Vis
P005-87
In Commercial Distribution

  • 05407008320256 ()


  • Assistive input-control operation training device, selection techniques
Twister Button (300 mm) Red
mo-Vis
P005-86
In Commercial Distribution

  • 05407008320249 ()


  • Assistive input-control operation training device, selection techniques
Twister Button (300 mm) Black
mo-Vis
P005-85
In Commercial Distribution

  • 05407008320232 ()


  • Assistive input-control operation training device, selection techniques
Twister Button (1500 mm) Green
mo-Vis
P005-79
In Commercial Distribution

  • 05407008320225 ()


  • Assistive input-control operation training device, selection techniques
Twister Button (1500 mm) Blue
mo-Vis
P005-78
In Commercial Distribution

  • 05407008320218 ()


  • Assistive input-control operation training device, selection techniques
Twister Button (1500 mm) Yellow
mo-Vis
P005-77
In Commercial Distribution

  • 05407008320201 ()


  • Assistive input-control operation training device, selection techniques
Twister Button (1500 mm) Red
mo-Vis
P005-76
In Commercial Distribution

  • 05407008320195 ()


  • Assistive input-control operation training device, selection techniques
Twister Button (1500 mm) Black
mo-Vis
P005-75
In Commercial Distribution

  • 05407008320188 ()


  • Assistive input-control operation training device, selection techniques
Actuator Keypad Paddle R-net CJSM2
mo-Vis
P016-99
In Commercial Distribution

  • 05407008320164 ()


  • Assistive input-control operation training device, selection techniques
Actuator Keypad Button R-net CJSM2
mo-Vis
P016-98
In Commercial Distribution

  • 05407008320157 ()


  • Assistive input-control operation training device, selection techniques
Actuator Keypad Paddle R-net CJSM1
mo-Vis
P016-97
In Commercial Distribution

  • 05407008320140 ()


  • Assistive input-control operation training device, selection techniques
Actuator Keypad Button R-net CJSM1
mo-Vis
P016-96
In Commercial Distribution

  • 05407008320133 ()


  • Assistive input-control operation training device, selection techniques
RehaCom Keyboard
HASOMED GmbH
Reha0099
In Commercial Distribution

  • 04260397620960 ()
Reha0099

  • Assistive keyboard aid
A device designed to assist a person with a disability in the techniques of selecting the correct input device in order to operate a connected primary device.
Pride Mobility Products Corp
TWISTER
In Commercial Distribution

  • 00606509900140 ()
N/A

  • Assistive input-control operation training device, selection techniques
Ion exchange chromatography analyzer with lithium accelerated column, LED monitor, computer, autosampler and Openlab software
BIOCHROM LIMITED
80-6000-50
In Commercial Distribution

  • 05056336800192 ()


  • Amino acid analyser IVD
No Audio Remote Network Station with Dell OptiPlex 7490 23.8" All-In-One Computer SW 02-18 unicast
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7490-U
In Commercial Distribution

  • 00851725007269 ()
RNS-6804-7490-U

  • Centralized patient monitor
No Audio Remote Network Station with Dell OptiPlex 7480 23.8" All-In-One Computer SW 02-18 unicast
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7480-U
In Commercial Distribution

  • 00851725007245 ()
RNS-6804-7480-U

  • Centralized patient monitor
No Description
SRS Medical Systems, Inc.
900-014-2
In Commercial Distribution

  • 00890477000296 ()


  • Biofeedback system application software
  • Electromyograph
No Description
SRS Medical Systems, Inc.
900-015-2
In Commercial Distribution

  • 00890477000159 ()


  • Biofeedback system application software
  • Electromyograph
No Description
SRS Medical Systems, Inc.
900-036
In Commercial Distribution

  • 00890477000081 ()


  • Biofeedback system application software
  • Electromyograph
No Description
SRS Medical Systems, Inc.
900-023
In Commercial Distribution

  • 00890477000173 ()


  • Biofeedback system application software
  • Electromyograph
No Description
SRS Medical Systems, Inc.
900-034
In Commercial Distribution

  • 00890477000074 ()


  • Biofeedback system application software
  • Electromyograph
Custom Abutment Zirconia, for Straumann RN, incl. TAN screw
Institut Straumann AG
Final Abutments
In Commercial Distribution

  • 07630031717757 ()
040.688

  • Dental implant suprastructure, permanent, preformed
RN Screw for CARES® Abutment, ZrO2 , and instructions for use
Institut Straumann AG
Screws
In Commercial Distribution

  • 07630031728913 ()
048.788

  • Dental prosthesis/implant abutment screw
No Description
Edan Instruments, Inc.
SE-2012
In Commercial Distribution

  • 06944413800977 ()


  • Electrocardiograph, professional, multichannel
No Description
Edan Instruments, Inc.
SE-2003
In Commercial Distribution

  • 06944413800960 ()


  • Electrocardiograph, professional, multichannel
Cardea SOLO PC Software - ECG analysis software (D300)
CARDIAC INSIGHT, INC.
D300
In Commercial Distribution

  • 00857553006139 ()
D300

  • Electrocardiographic ambulatory recorder
StealthView Software & Smart Cable - ECG analysis software (D300) and data transfer cable (C300).
CARDIAC INSIGHT, INC.
C300/D300
Not in Commercial Distribution

  • 00857553006092 ()
  • 00857553006061 ()
C300/D300

  • Electrocardiographic ambulatory recorder
The VidiStar PACS & DICOM Viewer Software system is a picture archiving and communications system (PACS) intended to be used as a networked Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The VidiStar PACS & DICOM Viewer Software is comprised of modular software programs that run on standard “off-the-shelf” personal computers, business computers, and servers running standard operating systems. VidiStar PACS & DICOM Viewer Software system is an image, data storage and display software that accepts DICOM data from laboratories, which support DICOM standard imaging data and structured reporting transfer(s). The system provides the capability to: organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, perform quantitative measurements, and create DICOM structure reports, all over the Internet.
Fujifilm Healthcare Americas Corporation
4.X.X
In Commercial Distribution

  • 00869047000431 ()


  • Radiological PACS software
CONNECTING CABLE APCO9
Edwards Lifesciences LLC
APCO9
In Commercial Distribution

  • 00690103165418 ()

  • Length: 108 Inch
APCO9

  • Electrical-only medical device connection cable, reusable
VIGILEO ANALOG SLAVE CABLE, DATEX DIN7
Edwards Lifesciences LLC
MHFD1
In Commercial Distribution

  • 00690103187267 ()

  • Length: 96 Inch
MHFD1

  • Electrical-only medical device connection cable, reusable
CONNECTING CABLE APCO9X2
Edwards Lifesciences LLC
APCO9X2
In Commercial Distribution

  • 00690103184976 ()

  • Length: 216 Inch
APCO9X2

  • Electrical-only medical device connection cable, reusable
PRESSURE SLAVE CABLE
Edwards Lifesciences LLC
MHANNK
In Commercial Distribution

  • 00690103181456 ()

  • Length: 8 Feet
MHANNK

  • Electrical-only medical device connection cable, reusable
PRESSURE SLAVE CABLE
Edwards Lifesciences LLC
MHANM8
In Commercial Distribution

  • 00690103186093 ()

  • Length: 8 Feet
MHANM8

  • Electrical-only medical device connection cable, reusable
PRESSURE SLAVE CABLE
Edwards Lifesciences LLC
MHAND
In Commercial Distribution

  • 00690103181449 ()

  • Length: 8 Feet
MHAND

  • Electrical-only medical device connection cable, reusable
PRESSURE SLAVE CABLE
Edwards Lifesciences LLC
MHANM5
In Commercial Distribution

  • 00690103181418 ()

  • Length: 8 Feet
MHANM5

  • Electrical-only medical device connection cable, reusable
DeepRhythmAI is a cloud-based software that utilizes AI algorithms to assess cardiac arrhythmias using a single- or two-lead ECG data from adult patients. It is intended for use by a healthcare solution integrator to build web, mobile or another types of applications to let qualified healthcare professionals review and confirm the analytic result. The product supports downloading and analyzing data recorded in the compatible formats from ECG devices such as Holter, Event recorder, Outpatient Cardiac Telemetry devices or other similar recorders when the assessment of the rhythm is necessary. The product can be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. DeepRhythmAI can be integrated into medical devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device. DeepRhythmAI is not for use in life-supporting or sustaining systems or ECG Alarm devices. Interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms and other diagnostic information.
MEDICALGORITHMICS S A
Type: DRAI
In Commercial Distribution

  • 05903021560742 ()


  • Cardiopulmonary physiological parameter analysis software
The DeepRhythmAI (DRAI) is a cloud-based software for automated analysis of ECG data. It uses a scalable Application Programming Interface (API) to enable easy integration. The main component of DeepRhythmAI is an automated proprietary deep-learning algorithm, which measures and analyzes ECG data to provide qualified healthcare professional with supportive information for review. DeepRhythmAI can be integrated into medical devices.
MEDICALGORITHMICS S A
Type: DRAI
In Commercial Distribution

  • 05903021560131 ()


  • Cardiopulmonary physiological parameter analysis software
Cart 48 Inch
ST. JUDE MEDICAL, INC.
H701313
In Commercial Distribution

  • 05415067013132 ()
H701313

  • Cardiac catheterization monitoring system
Cart 24 Inch
ST. JUDE MEDICAL, INC.
H701312
In Commercial Distribution

  • 05415067013125 ()
H701312

  • Cardiac catheterization monitoring system
Cardea SOLO Analysis Package - ECG analysis software (D300) and data transfer cable (C300).
CARDIAC INSIGHT, INC.
C300/D300
In Commercial Distribution

  • 00857553006122 ()
  • 10857553006129 ()
C300/D300

  • Electrocardiographic ambulatory recorder
Cardea SOLO Wearable Sensor (M300)
CARDIAC INSIGHT, INC.
M300-5
In Commercial Distribution

  • 10857553006112 ()
  • 00857553006115 ()
M300-5

  • Electrocardiographic ambulatory recorder
No Description
Siemens Healthcare GmbH
11060620
In Commercial Distribution

  • 04056869026367 ()


  • Full-body CT system
No Description
ATsens.co.,Ltd.
ATP-C130
In Commercial Distribution

  • 18800069700175 ()
  • 08800069700178 ()
  • 28800069700172 ()


  • Electrocardiographic long-term ambulatory recording analyser
PACKAGE, EVO AND PATHFINDER SL
SPACELABS HEALTHCARE (WASHINGTON), INC
EVO Recorder
In Commercial Distribution

  • 10841522127229 ()
040-1761-00

  • Electrocardiographic ambulatory recorder
  • Electrocardiographic long-term ambulatory recording analyser
No Description
Avante
60130H
In Commercial Distribution

  • 00815871021425 ()


  • Electrocardiographic ambulatory recorder
CardioSTAT Installation Kit - ECG Recorder 14D Test
Icentia Inc.
10-006
In Commercial Distribution

  • 27540279250142 ()


  • Electrocardiographic ambulatory recorder
CardioSTAT Installation Kit - ECG Recorder 7D Test
Icentia Inc.
10-006
In Commercial Distribution

  • 27540279250074 ()


  • Electrocardiographic ambulatory recorder
CardioSTAT Installation Kit - ECG Recorder 2D Test.
Icentia Inc.
10-006
In Commercial Distribution

  • 27540279250029 ()


  • Electrocardiographic ambulatory recorder
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