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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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Computer software for the configuration of SENSIMED Triggerfish® monitoring session and subsequent downloading, display and analysis of data from these sessions
Sensimed SA
V3
In Commercial Distribution

  • 07640153470157 ()
ST8000

  • Ocular volume ambulatory recording system software
UniMatch PLUS Software analyzes the reaction patterns of UniTray™ and AllSet+™ Gold kits for the determination of Human Leukocyte Antigens (HLA) allele assignment by comparison to the IMGT/HLA database.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022496 ()
790111

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
No Description
M2S, INC.
4.x
Not in Commercial Distribution

  • B119PREVIEW0 ()


  • Radiology information system application software
Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store ultrasound images for computerized three-dimensional image processing, from raw 2D ultrasound series.
MEDGE PLATFORMS INC
Classic
Not in Commercial Distribution

  • B118314170 ()


  • Ultrasound imaging system application software
Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store ultrasound images for computerized three-dimensional image processing, from raw 2D ultrasound series.
MEDGE PLATFORMS INC
Classic
Not in Commercial Distribution

  • B118314160 ()


  • Ultrasound imaging system application software
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M020101
In Commercial Distribution

  • 00817020020785 ()


  • Visual-reinforcement-audiometry reward system
ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM
NORAV MEDICAL LTD.
NH301
In Commercial Distribution

  • 07290110252748 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
THD Proctostation is an integrated, modular and expandable one-stop platform for the Colo-Rectal Surgeon/Proctologist, to perform Anorectal manometry, EAUS and High Resolution Anoscopy. It includes: - THD Procto Software - proctology integrated software - Dedicated hardware composed of an All in One professional Personal Compuiter - Insulation Transformer - Procto Trolley with pivoting wheels, brakes and orientable dringging handle
THD SPA
THD Proctostation
In Commercial Distribution

  • 18033737712389 ()
800198

  • Ultrasound imaging system application software
THD 4K CAM is a very-high-resolution video camera, which allows shooting up to 4K resolution using THD's diagnostic and surgical devices, equipped with a special mechanical connection interface and septic protection sleeve. Capture is done using the THD ProctoSoftware interface, a software suite that allows for the recording of clinical data such as patient records, examination, anorectal canal images, anorectal canal ultrasound images, and anorectal pressure values (anorectal manometry) when used with appropriate medical devices including the purchased video camera.
THD SPA
THD 4K CAM
In Commercial Distribution

  • 18033737712341 ()
800195

  • Ultrasound imaging system application software
No Description
AUGMEDICS LTD
ACC00001
In Commercial Distribution

  • 07290113780262 ()


  • Multi-purpose stereotactic surgery system
No Description
AUGMEDICS LTD
ACC00008
In Commercial Distribution

  • 07290113780231 ()


  • Multi-purpose stereotactic surgery system
Selenia® Dimensions® C-View Software is a software feature where a standard digital mammography image is generated from data acquired during a standard resolution breast tomosynthesis scan.
Hologic, Inc.
C-View
In Commercial Distribution

  • 15420045500020 ()
SW-03052

  • Basic diagnostic x-ray system application software
No Description
Radiobotics ApS
v.1.
In Commercial Distribution

  • 05700002173614 ()


  • X-ray image interpretive software
Temp Pal is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. This system is reusable and intended for armpit temperature monitoring for persons of all age. The temperature data of device is not intended to replace the advice, diagnosis, nor treatment recommendations of doctor. Temp Pal can be used at home and healthcare center.
iWEECARE Co., Ltd.
STP-MB01-1
In Commercial Distribution

  • 04712977931060 ()
  • 14712977931067 ()


  • Wireless patient thermometer, reusable
The wireless Enfasmart FeverSense Continuous Monitoring Thermometer is a non-invasive and re-usable electronic device for home use. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.
VIVALNK, INC.
VV220
In Commercial Distribution

  • 00865064000164 ()


  • Wireless patient thermometer, reusable
The wireless Fever Scout™ Continuous Monitoring thermometer is a non-invasive and re-usable electronic device for home use. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.
VIVALNK, INC.
VV200
In Commercial Distribution

  • 00865064000119 ()


  • Wireless patient thermometer, reusable
The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, and Bioassay module. This model includes a well counter with 2 inch of lead shielding.
Mirion Technologies (capintec), Inc.
5430-30154
In Commercial Distribution

  • 00859942006423 ()
5430-30154

  • Thyroid-uptake nuclear medicine system
The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, and Bioassay module.
Mirion Technologies (capintec), Inc.
Captus 4000e Thyroid Uptake System
In Commercial Distribution

  • 00859942006096 ()
5430-30151

  • Thyroid-uptake nuclear medicine system
The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, Bioassay module, Wipe Test Module, and Lab Tests.
Mirion Technologies (capintec), Inc.
Captus 4000e Thyroid System with Well
In Commercial Distribution

  • 00859942006102 ()
5430-30152

  • Thyroid-uptake nuclear medicine system
No Description
BRAINOMIX LIMITED
2.2
In Commercial Distribution

  • B720BX360ELUNG220 ()


  • X-ray image interpretive software
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