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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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OAS Server for Summit Sample Handling System
ORTHO-CLINICAL DIAGNOSTICS, INC.
936416
In Commercial Distribution

  • 10758750005499 ()
936416

  • Laboratory instrument/analyser application software IVD
OAS 400 MHz Workstation Refurbished for Summit Sample Handling System
ORTHO-CLINICAL DIAGNOSTICS, INC.
936415F
In Commercial Distribution

  • 10758750005482 ()
936415F

  • Laboratory instrument/analyser application software IVD
No Description
EUROIMMUN Medizinische Labordiagnostika AG
YG 0250-0101-7
In Commercial Distribution

  • 04049016135210 ()


  • Laboratory instrument/analyser application software IVD
No Description
EUROIMMUN Medizinische Labordiagnostika AG
YG 0011-0101
In Commercial Distribution

  • 04049016068815 ()


  • Laboratory instrument/analyser application software IVD
No Description
EUROIMMUN Medizinische Labordiagnostika AG
YG 0006-0101
In Commercial Distribution

  • 04049016068785 ()


  • Laboratory instrument/analyser application software IVD
No Description
EUROIMMUN Medizinische Labordiagnostika AG
YG 0071-0101
In Commercial Distribution

  • 04049016148708 ()


  • Laboratory instrument/analyser application software IVD
No Description
Quantib B.V.
2.2
In Commercial Distribution

  • 08719689791261 ()


  • MRI system application software
No Description
Quantib B.V.
1.5
In Commercial Distribution

  • 08719689791254 ()


  • MRI system application software
No Description
Quantib B.V.
2.1
In Commercial Distribution

  • 08719689791216 ()


  • MRI system application software
No Description
Quantib B.V.
2.0
In Commercial Distribution

  • 08719689791179 ()


  • MRI system application software
No Description
Quantib B.V.
1.8
In Commercial Distribution

  • 08719689791148 ()


  • MRI system application software
No Description
Quantib B.V.
1.7
In Commercial Distribution

  • 08719689791094 ()


  • MRI system application software
No Description
Quantib B.V.
1.4
In Commercial Distribution

  • 08719689791070 ()


  • MRI system application software
No Description
Quantib B.V.
1.6
In Commercial Distribution

  • 08719689791032 ()


  • MRI system application software
No Description
Quantib B.V.
1.5
In Commercial Distribution

  • 08719689791001 ()


  • MRI system application software
No Description
Philips North America LLC
Capsule Surveillance System
In Commercial Distribution

  • 03615041990332 ()


  • Clinical management support software
Bioserenity CLOUD is a web-based information system that receives the EEG signals from the recorder through a paired Wi-Fi connection. The cloud platform enables long-term storage and display of the recorded signals.
BIOSERENITY MEDICAL DEVICES GROUP
1012-21002-US
Not in Commercial Distribution

  • 03615220004270 ()


  • Bio-energy preliminary diagnosis system application software
No Description
NXSTAGE MEDICAL, INC.
NX1272
Not in Commercial Distribution

  • M535NX1272 ()


  • Clinical management support software
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
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
No Description
VISIA LAB SRL
dIFine ANCA Classifier
In Commercial Distribution

  • 08059304340239 ()


  • Laboratory instrument/analyser application software IVD
No Description
VISIA LAB SRL
dIFine DNA Classifier
In Commercial Distribution

  • 08059304340222 ()


  • Laboratory instrument/analyser application software IVD
No Description
VISIA LAB SRL
dIFine ANA HEp-2 Classifier
In Commercial Distribution

  • 08059304340215 ()


  • Laboratory instrument/analyser application software IVD
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
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
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
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
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
Computer aided detection system of suspicious lesions in automated breast ultrasound images.
QVIEW MEDICAL
3.4.4
In Commercial Distribution



  • Ultrasound imaging system application software
No Description
QVIEW MEDICAL
3.4.3
In Commercial Distribution

  • B630QVCS343 ()


  • Ultrasound imaging system application software
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