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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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ZAAG Reorder Kit for 4 Roots (Standard) (No Tools)
Zest Anchors, LLC
04010
In Commercial Distribution

  • 00840481109089 ()


  • Dental implant suprastructure, permanent, preformed
MultiView™ is a software application that provides various image processing and measurement tools to facilitate the interpretation of breast MRI images and enable diagnosis.
Hologic, Inc.
MultiView
In Commercial Distribution

  • 15420045504684 ()
SFW-03541

  • Laboratory instrument/analyser application software IVD
syngo Application Software VD1,syngo Application Software KIT,Registered Medical Devices,syngo Application Software GTIN 04056869012902
Siemens Healthcare GmbH
10849112
In Commercial Distribution

  • 04056869025919 ()


  • Basic diagnostic x-ray system application software
The Minuteful - kidney test is an in-vitro diagnostic, home-use urine analysis test system for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR), with results that are intended to be used in conjunction with clinical evaluation as an aid in the assessment of kidney health.
HEALTHY.IO LTD
MNT KDN.US.GEN
In Commercial Distribution

  • 17290017272471 ()


  • Self-testing data clinician presentation application software IVD
CADDIE is cloud based artificial intelligence medical device software. CADDIE interfaces with the video feed generated by an endoscopic video processor during a colonoscopy procedure. The software is intended to be used by trained and qualified healthcare professionals as an accompaniment to video endoscopy for the purpose of drawing attention to regions with visual characteristics consistent with colonic mucosal lesions (such as polyps and adenomas). CADDIE analyses the data from the endoscopic video processor in real-time and provides information to aid the endoscopist in detecting suspected colorectal polyps, if they are in the field of view of the endoscope. The areas highlighted by CADDIE are not to be interpreted as definite polyps or adenomas. The responsibility to make a decision as to whether or not a highlighted region contains a polyp or is an adenoma lies with the user. The endoscopist is responsible for reviewing CADDIE suspected polyp areas and confirming the presence or absence of a polyp and its classification based on their own medical judgement.
ODIN MEDICAL LIMITED
v1.4.x
In Commercial Distribution

  • 15065010840024 ()


  • Endoscopic video image interpretive software
Norav 1200 Series PC-ECG Software Upgrade Kit with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) - S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2toS2
In Commercial Distribution

  • 07290110252786 ()
HASP-SW-K-S2-S1-01

  • Cardiopulmonary stress exercise monitoring system computer
MUCheck® Independent Dose Calculation Software. MUCheck® Software. MUCheck® Software Suite. Oncology Data Systems, Inc.
Oncology Data Systems Inc
MUCheck®
In Commercial Distribution

  • 00860175002403 ()


  • Radiation therapy software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11149926
Not in Commercial Distribution

  • 04056869006840 ()


  • Radiological PACS software
syngo Application Software VE2
Siemens Healthcare GmbH
11327667
In Commercial Distribution

  • 04056869124162 ()


  • Basic diagnostic x-ray system application software
syngo Application Software VD1
Siemens Healthcare GmbH
10849124
In Commercial Distribution

  • 04056869012902 ()


  • Basic diagnostic x-ray system application software
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