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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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QUASAR - G34310010170

Grid 3D Image Distortion Analysis System- Includes One Phantom and 2 software licenses..
Modus Medical Devices Inc
100-1017
In Commercial Distribution

  • G34310010170 ()


  • Multi-modality therapeutic radiation phantom, test object

PantOs 16 xp - E31584682012000

Analog Panoramic X-Ray Unit with 24x30 cm cassette, including patient positioning items
BLUO ELECTRONICS SRL
8468201200
In Commercial Distribution

  • E31584682012000 ()


  • Stationary panoramic dental x-ray system, analogue

PantOs 16 xp Ceph - E31584682005000

Analog Panoramic and Cephalometric X-Ray Unit with 10x8" cassette, including patient positioning items
BLUO ELECTRONICS SRL
8468200500
In Commercial Distribution

  • E31584682005000 ()


  • Stationary panoramic dental x-ray system, analogue

PantOs 16 xp - E31584682001000

Analog Panoramic X-Ray Unit with 15x30 cm cassette, including patient positioning items
BLUO ELECTRONICS SRL
8468200100
In Commercial Distribution

  • E31584682001000 ()


  • Stationary panoramic dental x-ray system, analogue

GoCheck Kids - B430GCKIOS5430

GoCheck Kids mobile medical application for iPhone
Gobiquity, Inc.
iPhone 5.4.3
In Commercial Distribution

  • B430GCKIOS5430 ()


  • External ocular measurement camera

GoCheck Kids - B43071000010

Photoscreener with Flash Concentrator, mobile platform (i.e., iPhone 15 Pro) and current GoCheck Kids software.
Gobiquity, Inc.
V5 i15 PFC
In Commercial Distribution

  • B43071000010 ()


  • External ocular measurement camera

GoCheck Kids - B43060030010

Photoscreener with Flash Concentrator, mobile platform (i.e., iPhone 7 Plus) and current GoCheck Kids software.
Gobiquity, Inc.
V5 i7 PFC
In Commercial Distribution

  • B43060030010 ()


  • External ocular measurement camera

OMNI-Lab - G600OL12SP5

OMNI-Lab is a Laboratory Information System (LIS) intended to be used for the management of clinical information. The OMNI-Lab stand-alone software is only used by trained health professionals.
Omnitech Labs Inc.
12 SP5
In Commercial Distribution

  • G600OL12SP5 ()


  • Clinical laboratory information system application software

Nx2me Connected Health Nx2me Clinician Portal - M535NX1225NX1380

No Description
NXSTAGE MEDICAL, INC.
NX1380
Not in Commercial Distribution

  • M535NX1225NX1380 ()


  • Medical equipment clinical data interfacing software

Nx2me Connected Health Nx2me App - M535NX1225NX1379

No Description
NXSTAGE MEDICAL, INC.
NX1379
Not in Commercial Distribution

  • M535NX1225NX1379 ()


  • Medical equipment clinical data interfacing software
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