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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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MyLUX(TM) Patient Kit with mobile device
BOSTON SCIENTIFIC CORPORATION
666259-100
In Commercial Distribution

  • 00802526607363 ()
666259-100

  • Implantable cardiac device management application software
iCodeConnect Software
BMC Medical Co., Ltd.
420002
In Commercial Distribution

  • 06948538362075 ()


  • Ventilator application software
SW 2692 CARELINK DEVICE COMMAND LIBRARY
MEDTRONIC, INC.
2692
In Commercial Distribution

  • 00763000378363 ()


  • Implantable cardiac device management application software
SW 2691 CARELINK INST COMMAND LIBRARY
MEDTRONIC, INC.
2691
In Commercial Distribution

  • 00763000378356 ()


  • Implantable cardiac device management application software
SOFTWARE 5242 TRIAGEHF US
MEDTRONIC, INC.
5242
In Commercial Distribution

  • 00763000351656 ()


  • Implantable cardiac device management application software
SW ZA420 ACCURHYTHM AI ALGORITHM PAUSE
MEDTRONIC, INC.
ZA420
In Commercial Distribution

  • 00763000504533 ()


  • Implantable cardiac device management application software
SW ZA410 ACCURHYTHM AI ALGORITHM AF
MEDTRONIC, INC.
ZA410
In Commercial Distribution

  • 00763000504526 ()


  • Implantable cardiac device management application software
SW ZA400 ACCURHYTHM AI POST-PROCESSING
MEDTRONIC, INC.
ZA400
In Commercial Distribution

  • 00763000504519 ()


  • Implantable cardiac device management application software
SW D00U024 CARELINK SS LINQ II ICM
MEDTRONIC, INC.
D00U024
In Commercial Distribution

  • 00763000754914 ()


  • Implantable cardiac device management application software
SW D00U027 SS LINQ II PLATFORM APP
MEDTRONIC, INC.
D00U027
In Commercial Distribution

  • 00763000891091 ()


  • Implantable cardiac device management application software
SW CLN CARELINK NETWORK RELEASE
MEDTRONIC, INC.
CLN
In Commercial Distribution

  • 00763000017347 ()


  • Implantable cardiac device management application software
SW D00U004 SS PERCEPTA SERENA SOLERA
MEDTRONIC, INC.
D00U004
In Commercial Distribution

  • 00763000002046 ()


  • Implantable cardiac device management application software
SW D00U003 SS AZURE ASTRA
MEDTRONIC, INC.
D00U003
In Commercial Distribution

  • 00763000002039 ()


  • Implantable cardiac device management application software
No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
lnclinometer wireless
In Commercial Distribution

  • EPTWT430360 ()
T43036

  • Bone densitometry ultrasound phantom, test object
Galilei G6 Lens Professional
SIS AG, Surgical Instrument Systems
G6
In Commercial Distribution

  • 07640167751242 ()
410.030.007

  • Optical low coherence reflectometry (OLCR) biometer
  • Eye anterior segment analyser
  • Corneal topography system application software
The SpineUs™ System is a diagnostic ultrasound system, which consists of the FDA cleared Clarius Ultrasound Scanner C3 HD3 (K213436), a consumer PC, a tracking system with OptiTrack cameras connected to a POE switch and active LED markers, and the SpineUs™ computer application. The SpineUs™ computer application, installed in the consumer PC, processes the ultrasound imaging data received from the Clarius Ultrasound Scanner and the tracking data received from the tracking system. The SpineUs™ computer application allows the operator to view ultrasound images of the spine, segment the ultrasound images using artificial intelligence, generate and visualize 3D reconstructions of the surface of the spine in real-time, measure spine-related anatomical components (e.g., intervertebral angles and spine curvature), review and manage patient measurement data, and generate and export printable reports.
VERDURE IMAGING, INC.
000010
In Commercial Distribution

  • G618000010 ()


  • Ultrasound imaging system operation software
  • Hand-held ultrasound imaging system, body-surface
  • Ultrasound imaging system operator console
iFusion 80 with 12 MP Camera
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006766 ()
700-54542-001

  • Ophthalmic spectral-domain optical coherence tomography system
  • Ophthalmic fundus camera
iVue NR for iFusion USCFG 230V
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006650 ()
700-49003-005

  • Ophthalmic spectral-domain optical coherence tomography system
  • Ophthalmic fundus camera
iVue NR for iFusion 230V
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006643 ()
700-49002-005

  • Ophthalmic spectral-domain optical coherence tomography system
  • Ophthalmic fundus camera
iVue NR for iFusion USCFG 120V
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006636 ()
700-49001-005

  • Ophthalmic spectral-domain optical coherence tomography system
  • Ophthalmic fundus camera
iVue NR for iFusion 120V
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006629 ()
700-49000-005

  • Ophthalmic spectral-domain optical coherence tomography system
  • Ophthalmic fundus camera
iVue NR for iFusion USCFG System w/ 230V Table
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006308 ()
700-48586-003

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system
iVue NR for iFusion System w/ 230V Table
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006292 ()
700-48585-003

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system
iVue NR for iFusion USCFG System w/ 120V Table
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006247 ()
700-48371-003

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system
iVue NR for iFusion System w/ 120V Table
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006230 ()
700-48363-003

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system
iVue NR for iFusion USCFG 230V
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006209 ()
700-49003-004

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system
iVue NR for iFusion 230V
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006193 ()
700-49002-004

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system
iVue NR for iFusion USCFG 120V
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006186 ()
700-49001-004

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system
iVue NR for iFusion 120V
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006179 ()
700-49000-004

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system
Pathway® CTS 2000
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
CTS2000
In Commercial Distribution

  • 00852423006011 ()
CTS2000

  • Psychophysiological biofeedback system
  • Perineal orifice incontinence-control electrical stimulation system, professional
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