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
VAREX IMAGING CORPORATION
Precision RXi D
In Commercial Distribution

  • 00854344007092 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Platinum One RF
In Commercial Distribution

  • 00854344007085 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DRF (RF/DR)
In Commercial Distribution

  • 00854344007078 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
i5 RF
In Commercial Distribution

  • 00854344007061 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus-DRF
In Commercial Distribution

  • 00854344007054 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
i5 DR
In Commercial Distribution

  • 00854344007047 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR
In Commercial Distribution

  • 00854344007030 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus, DRF, v2.5
In Commercial Distribution

  • 00854344007023 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus, DR, v3.1
In Commercial Distribution

  • 00854344007016 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
i5 DSA
In Commercial Distribution

  • 00854344007009 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
INFIMED, INC.
2.5
Not in Commercial Distribution

  • 00858086006122 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
INFIMED, INC.
3.0
Not in Commercial Distribution

  • 00858086006115 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
INFIMED, INC.
PlatinumOne DSA
Not in Commercial Distribution

  • 00858086006108 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
INFIMED, INC.
Nexus DR
Not in Commercial Distribution

  • 00858086006092 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
INFIMED, INC.
Precision MPi DSA
Not in Commercial Distribution

  • 00858086006085 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
INFIMED, INC.
Precision MPi RF
Not in Commercial Distribution

  • 00858086006078 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
INFIMED, INC.
Precision RXi D
Not in Commercial Distribution

  • 00858086006061 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
INFIMED, INC.
i5 RF
Not in Commercial Distribution

  • 00858086006054 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
INFIMED, INC.
PlatinumOne RF
Not in Commercial Distribution

  • 00858086006047 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
INFIMED, INC.
Nexus-DRF
Not in Commercial Distribution

  • 00858086006030 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
INFIMED, INC.
Nexus DRF (RF/DR)
Not in Commercial Distribution

  • 00858086006023 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
INFIMED, INC.
i5 DR
Not in Commercial Distribution

  • 00858086006016 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
INFIMED, INC.
i5 DSA
Not in Commercial Distribution

  • 00858086006009 ()


  • X-ray system computer, diagnostic, general-purpose
QG-TV-CM
CARESTREAM HEALTH, INC.
DRX - Ascend System
In Commercial Distribution

  • 60889976574645 ()
6574644

  • X-ray system computer, diagnostic, general-purpose
QG-TV10-C TECHVISION RS-590 WITH Q-VISIO
CARESTREAM HEALTH, INC.
DRX - Ascend System
In Commercial Distribution

  • 60889976574638 ()
6574636

  • X-ray system computer, diagnostic, general-purpose
QG-TV10-IPF-MAT TECHVISION QS-550 DRX AT
CARESTREAM HEALTH, INC.
QG-TV-IP-FM
In Commercial Distribution

  • 60889976573341 ()
6573349

  • X-ray system computer, diagnostic, general-purpose
QG-TV10-IPC-MAT TECHVISION RS-590 DRX AT
CARESTREAM HEALTH, INC.
QG-TV-IP-CM
In Commercial Distribution

  • 60889976573327 ()
6573323

  • X-ray system computer, diagnostic, general-purpose
QG-TV10-F-MAT TECHVISION QS-550 Q-VISION
CARESTREAM HEALTH, INC.
QG-TV-FM
In Commercial Distribution

  • 60889976573303 ()
6573307

  • X-ray system computer, diagnostic, general-purpose
QG-TV10-IPF TECHVISION QS-550 WITH DRX
CARESTREAM HEALTH, INC.
QG-TV-IP-F
In Commercial Distribution

  • 60889976573334 ()
6573331

  • X-ray system computer, diagnostic, general-purpose
QG-TV10-IPC TECHVISION RS-590 WITH DRX
CARESTREAM HEALTH, INC.
QG-TV-IP-C
In Commercial Distribution

  • 60889976573310 ()
6573315

  • X-ray system computer, diagnostic, general-purpose
QG-TV10-F TECHVISION QS-550 WITH Q-VISIO
CARESTREAM HEALTH, INC.
QG-TV-F
In Commercial Distribution

  • 60889976573297 ()
6573299

  • X-ray system computer, diagnostic, general-purpose
TECHVISIN SYSTM,RS-590 WIT
CARESTREAM HEALTH, INC.
DRX - Ascend System
In Commercial Distribution

  • 60889976571866 ()
6571863

  • X-ray system computer, diagnostic, general-purpose
TECHVISION FOR CEILING SYSTEM
CARESTREAM HEALTH, INC.
DRX - Ascend System
In Commercial Distribution

  • 60889974005226 ()
1025907

  • X-ray system computer, diagnostic, general-purpose
Techvision for Ceiling Systm
CARESTREAM HEALTH, INC.
QG-TV-IP-C
In Commercial Distribution

  • 60889971065391 ()
1065390

  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DRF v3.5
In Commercial Distribution

  • 00810751030252 ()


  • X-ray system computer, diagnostic, general-purpose
Integrity
ELEKTA LIMITED
1526754
In Commercial Distribution

  • 05060191071062 ()


  • Accelerator system computer
XR-29 Solution v1.0
AGILITI HEALTH, INC.
v1.0
In Commercial Distribution

  • 00810040260001 ()


  • CT system computer
Medic Vision’s SafeCT-29 provides a vendor-neutral Radiation Dose Check functionality, in accordance with the Dose Check feature that is specified by the NEMA XR-25 Standard. The device is a software and hardware system which includes Computer, dedicated display and controls. The SafeCT-29 is interfaced to CT scanners that are not equipped with the Dose Check function. The device is connected to the CT Console video output via a standard video connector. The SafeCT-29 Computer’s internal video splitter captures the CT Console display video, in real time, without affecting neither the CT console itself nor its display. This analog video signal is digitized by a video grabber. The SafeCT-29 software analyzes the digital input video using OCR software continuously. The radiation dose information as calculated by the scanner and displayed to the CT operator is extracted and analyzed in real time. The SafeCT- 29 captures the video of the CT Console display in real time, without affecting neither the CT console itself nor its display and workflow. As specified by NEMA XR-25 Standard, the safeCT-29 notifies and alerts the CT operators, prior to a scan, if the estimated dose index is above the predefined values set by the operating group, practice, or organization. SafeCT-29 prevents continuing an over-the-limit scan unless dose levels are reconfirmed by the operator, in accordance with NEMA XR-29*.The device records the details of such events, including the operator details and decisions. This record is available to the user.
MEDIC VISION - IMAGING SOLUTIONS LTD
1.0
In Commercial Distribution

  • 07290016836202 ()
  • 00729001683639 ()


  • CT system computer
Easy-Set Mounting Hardware (pair) for use on 1-1/4" back canes. Hardware for Matrx Elite and PB Backs. Quick-release design.
Motion Concepts Inc
PBMH-X
In Commercial Distribution

  • 07540147000257 ()
PBMH-X

  • Wheelchair back rest positioner
E2 MiniSet Fixed Mounting Hardware (pair). Optional mounting hardware for Matrx E2 Backs (16H or less). Requires tools to remove.
Motion Concepts Inc
MSFX
In Commercial Distribution

  • 07540147000882 ()
MSFX

  • Wheelchair back rest positioner
Easy-Set Mounting Hardware (pair) for use on 1-1/8" back canes. Hardware for Matrx Elite and PB Backs. Quick-release design.
Motion Concepts Inc
PBMH-Q
In Commercial Distribution

  • 07540147000233 ()
PBMH-Q

  • Wheelchair back rest positioner
Universal Urethane Full Length Arm Pad w/ Hardware (ea)
PROACTIVE MEDICAL PRODUCTS, LLC
PP-RAPUF
In Commercial Distribution

  • 05060488573347 ()

  • Height: 4 Inch
  • Length: 8 Inch
  • Width: 2 Inch
PP-RAPUF

  • Wheelchair armrest
Universal Urethane Desk Length Arm Pad w/ Hardware (ea)
PROACTIVE MEDICAL PRODUCTS, LLC
PP-RAPUD
In Commercial Distribution

  • 05060488573330 ()

  • Width: 2 Inch
  • Height: 4 Inch
  • Length: 8 Inch
PP-RAPUD

  • Wheelchair armrest
Locking Bar for Back Plate includes Hardware (NEMOTO ONLY)
Innovative Medical Products, Inc
7541
In Commercial Distribution

  • 00696588001999 ()
7541

  • Operating table torso positioner
Locking Bar for Anterior Support & Hyperflexion Plate includes Hardware
Innovative Medical Products, Inc
7540
In Commercial Distribution

  • 00696588001982 ()
7540

  • Operating table torso positioner
LOGIQ E10s R2/R3 to R4 Upgrade with Hardware
GE Ultrasound Korea Ltd.
E10s R2R3 to R4 HW Upgrade
In Commercial Distribution

  • 00195278835765 ()
5946722

  • General-purpose ultrasound imaging system
32" SHELF FOR KM VBM CM CARRIERS INCLUDES HARDWARE
SKYTRON LLC
XMSH
In Commercial Distribution

  • 10841736114886 ()


  • General utility supply system, ceiling-mounted
22" SHELF FOR PM VBM CM CARRIERS INCLUDES HARDWARE
SKYTRON LLC
PMSH
In Commercial Distribution

  • 10841736114862 ()


  • General utility supply system, ceiling-mounted
16.5" SHELF FOR KM VBM CM CARRIERS INCLUDES HARDWARE
SKYTRON LLC
KMSH
In Commercial Distribution

  • 10841736114855 ()


  • General utility supply system, ceiling-mounted
Tri-Soft Headrest, 14" with Standard Straight Removable Adjustable Hardware
KI MOBILITY, LLC
Head Support
In Commercial Distribution

  • 00840363305998 ()

  • 14"
TS14SS

  • Wheelchair bracket/mount
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