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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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Software
Bard Access Systems, Inc.
Sherlockv1.1.1
In Commercial Distribution

  • 00801741121463 ()
Sherlockv1.1.1

  • Central venous catheter navigation system, electrocardiographic/magnetic
Software
Bard Access Systems, Inc.
Sherlockv1.1.0
In Commercial Distribution

  • 00801741121456 ()
Sherlockv1.1.0

  • Central venous catheter navigation system, electrocardiographic/magnetic
Software
Bard Access Systems, Inc.
SR8v1.0.2
In Commercial Distribution

  • 00801741121432 ()
SR8v1.0.2

  • General-purpose ultrasound imaging system
Software
Bard Access Systems, Inc.
SR8v1.0.1
In Commercial Distribution

  • 00801741121425 ()
SR8v1.0.1

  • General-purpose ultrasound imaging system
Software
INTUITIVE SURGICAL, INC.
610140
In Commercial Distribution

  • 00886874119433 ()


  • Medical video image recorder
No Description
Fujirebio Europe
15687
In Commercial Distribution

  • 05414470156870 ()


  • Laboratory instrument/analyser application software IVD
SOFTWARE, CODE-STAT CASEVIEW SOFTWARE INSTALL
PHYSIO-CONTROL, INC.
21340
In Commercial Distribution

  • 00883873837788 ()
21340-000850

  • Medical equipment clinical data interfacing software
The NilRead software application provides desktop and portable access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data, including mammography and breast tomosynthesis. NilRead also allows users to collaborate by sharing application sessions. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. For primary diagnosis, post process DICOM “for presentation” images must be used. On mobile platforms, this device is not intended for diagnostic use.
Hyland Software Canada ULC
NIL-READ-GLB
In Commercial Distribution

  • 00697978970017 ()


  • Radiological PACS software
PhySoft AMS™ is a web application used to obtain, track and trend patient data pertaining to the management of anemia, and to provide a schedule of erythropoiesis stimulating agent (ESA) dosage recommendations to help achieve and maintain target hemoglobin levels in dialysis patients. PhySoft AMS™ is intended to help physicians, nurses, clinicians and anemia managers manage anemia in adult stage 5 chronic kidney disease (CKD) patients.
PHYSICIAN SOFTWARE SYSTEMS, LLC
1
In Commercial Distribution

  • 00861858000303 ()


  • Nephrology information system application software
No Description
MetaSystems Hard & Software GmbH
Microscopic image acquisition
In Commercial Distribution

  • 04250406460007 ()


  • Laboratory instrument/analyser application software IVD
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