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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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STA Coag Expert® - 03607450000030

No Description
DIAGNOSTICA STAGO
V8
In Commercial Distribution

  • 03607450000030 ()
87111

  • Laboratory instrument/analyser application software IVD

Capsule Surveillance - 03615041990332

No Description
Philips North America LLC
Capsule Surveillance System
In Commercial Distribution

  • 03615041990332 ()


  • Clinical management support software

Alinity c ACE Assay File - 08058056685445

The Alinity c ACE Assay File is an accessory intended to be used for driving and influencing the use of the Alinity c system automated analyser hardware.
SENTINEL CH. SPA
06U86-1A
In Commercial Distribution

  • 08058056685445 ()
06U86-1A

  • Laboratory instrument/analyser application software IVD

ARCHITECT c ACE Assay File - 08058056685438

The ARCHITECT c ACE Assay File is an accessory intended to be used for driving and influencing the use of the ARCHITECT c systems automated analyser hardware.
SENTINEL CH. SPA
6U82-1A
In Commercial Distribution

  • 08058056685438 ()
6U82-1A

  • Laboratory instrument/analyser application software IVD

LIAISON® QuantiFERON® Software - 08056771103572

No Description
DIASORIN SPA
Q0001
In Commercial Distribution

  • 08056771103572 ()


  • Laboratory instrument/analyser application software IVD

Acuitas - 01812125010081

Labeled, OpGen branded flash drive containing IVD Acuitas AMR Gene Analysis Software.
Opgen, Inc.
CP3511
Not in Commercial Distribution

  • 01812125010081 ()
CP3511

  • Laboratory instrument/analyser application software IVD

QVCAD System Installation Kit - B630QVCSIK1202346

Installation Kit for QVCAD System Release 3.4.6 with Debian 12.2
QVIEW MEDICAL
12.02-3.4.6
Not in Commercial Distribution



  • Ultrasound imaging system application software

QVCAD System Installation Kit - B630QVCSIK1010344

Installation Kit for QVCAD System Release 3.4.4 with Debian 10.10
QVIEW MEDICAL
10.10-3.4.4
In Commercial Distribution



  • Ultrasound imaging system application software

QVCAD System Installation Kit - B630QVCSIK1010343

Installation Kit for QVCAD System Release 3.4.3 with Debian 10.10
QVIEW MEDICAL
10.10-3.4.3
In Commercial Distribution

  • B630QVCSIK1010343 ()


  • Ultrasound imaging system application software

QVCAD System - B630QVCS346

Computer aided detection system of suspicious lesions in automated breast ultrasound images.
QVIEW MEDICAL
3.4.6
Not in Commercial Distribution



  • Ultrasound imaging system application software
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