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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No Description
MEDIBLU MEDICAL LLC
FM10
In Commercial Distribution

  • B632MDB01007 ()
MDB01007

  • Multiple vital physiological parameter monitoring system, clinical
No Description
MEDIBLU MEDICAL LLC
MM3
In Commercial Distribution

  • B632MDB01005 ()
MDB01005

  • Multiple vital physiological parameter monitoring system, clinical
No Description
MEDIBLU MEDICAL LLC
MM12
In Commercial Distribution

  • B632MDB01003 ()
MDB01003

  • Multiple vital physiological parameter monitoring system, clinical
No Description
MEDIBLU MEDICAL LLC
MM15
In Commercial Distribution

  • B632MDB01002 ()
MDB01002

  • Multiple vital physiological parameter monitoring system, clinical
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
No Description
QVIEW MEDICAL
3.4.2
In Commercial Distribution



  • Ultrasound imaging system application software
No Description
QVIEW MEDICAL
3.3
In Commercial Distribution

  • B630QVCS33 ()


  • Ultrasound imaging system application software
No Description
MEDIBLU MEDICAL LLC
Blu15+
In Commercial Distribution

  • B632MDB01035 ()
MDB01035

  • Multiple vital physiological parameter monitoring system, clinical
No Description
MEDIBLU MEDICAL LLC
BLU 12+
In Commercial Distribution

  • B632MDB01034 ()
MDB01034

  • Multiple vital physiological parameter monitoring system, clinical
No Description
MEDIBLU MEDICAL LLC
BLU 12
In Commercial Distribution

  • B632MDB01028 ()
MDB01028

  • Multiple vital physiological parameter monitoring system, clinical
No Description
MEDIBLU MEDICAL LLC
MM5
In Commercial Distribution

  • B632MDB01004 ()
MDB01004

  • Multiple vital physiological parameter monitoring system, clinical
No Description
MEDIBLU MEDICAL LLC
MM17
In Commercial Distribution

  • B632MDB01001 ()
MDB01001

  • Multiple vital physiological parameter monitoring system, clinical
No Description
QVIEW MEDICAL
3.4
In Commercial Distribution



  • Ultrasound imaging system application software
No Description
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
AI1000
In Commercial Distribution

  • 00889024647343 ()
AI1000

  • Medical image management system
Visualize:Vascular is software that renders 3D images of vascular segments from ultrasound imaging.
SALIENT IMAGING
1.2
In Commercial Distribution

  • B725INITVV1 ()
  • B725INITVV12 ()
INITVV

  • Ultrasound imaging system application software
Nitrogen Plasma system
TRIWORKS GROUP SRL
PurePlasma
In Commercial Distribution

  • 08057168020083 ()


  • Nitrogen plasma skin surface treatment system
Plasma device
TRIWORKS GROUP SRL
AgeJet
In Commercial Distribution

  • 08057168020007 ()


  • Nitrogen plasma skin surface treatment system
Venue Sprint R5 MD
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
R5
In Commercial Distribution

  • 00195278754011 ()


  • Ultrasound imaging system application software
Vscan Air R3 for iOS
GE Vingmed Ultrasound AS
Air R3 for iOS
In Commercial Distribution

  • 00195278884749 ()


  • Ultrasound imaging system application software
Vscan Air R3 for Android
GE Vingmed Ultrasound AS
Air R3 for Android
In Commercial Distribution

  • 00195278884725 ()


  • Ultrasound imaging system application software
VX-100 is a battery-operated, portable X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-ray images. The VX-100 is designed for use in general-purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams. Because of its low power output, the CLAROX plus (Model VX-100) is intended for exclusive use on body extremities. The functions of the VX-100 handheld system are supported by software (firmware).
VSI Co., Ltd.
VX-100
In Commercial Distribution

  • 18800124900014 ()
  • 08800124900017 ()


  • Portable basic diagnostic x-ray system, digital
OR1 SmartScreen
Karl Storz GmbH & Co. KG
WM200
In Commercial Distribution

  • 04048551418147 ()


  • Physician-practice-management information system
KARL STORZ AIDA
Karl Storz GmbH & Co. KG
WD300
In Commercial Distribution

  • 04048551415320 ()
WD300

  • Physician-practice-management information system
NOGA XP-Cardiac Mapping System
BIOSENSE WEBSTER (ISRAEL) LTD.
FG170000
Not in Commercial Distribution

  • 10846835011678 ()
FG170000

  • Cardiac mapping system
CARTO 3 System
BIOSENSE WEBSTER (ISRAEL) LTD.
FG540000
In Commercial Distribution

  • 10846835000870 ()
FG-5400-00

  • Cardiac mapping system
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