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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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F&P InfoUSB
FISHER & PAYKEL HEALTHCARE LIMITED
900ICON203
In Commercial Distribution

  • 09420012429100 ()
  • 09420012424266 ()
900ICON203

  • Digital storage media
F&P InfoUSB
FISHER & PAYKEL HEALTHCARE LIMITED
900ICON202
In Commercial Distribution

  • 09420012427854 ()
  • 09420012423115 ()
900ICON202

  • Digital storage media
SMARTSTICK-5 PACK HC254
FISHER & PAYKEL HEALTHCARE LIMITED
900HC611
In Commercial Distribution

  • 09420012421524 ()
900HC611

  • Digital storage media
Leica Biosystems RDX QUICKSTOR 8863 USB3
Leica Biosystems Richmond, Inc.
23RDX8863
Not in Commercial Distribution

  • 00849832013235 ()

  • Device Size Text, specify:


  • Digital storage media
Leica Biosystems Cytovision Removable Archive Device
Leica Biosystems Richmond, Inc.
23STR003XXX001
Not in Commercial Distribution

  • 00849832005155 ()

  • Device Size Text, specify:


  • Digital storage media
No Description
KONAN MEDICAL, INC.
Cellchek
Not in Commercial Distribution

  • 04582275250428 ()


  • Eye anterior segment analyser software
CABLE 8580 DATA IR FOR 8840 WIN8 GLOBAL
MEDTRONIC, INC.
8580
In Commercial Distribution

  • 00643169425545 ()


  • Digital storage media
SL Console
MICROLIGHT CORPORATION OF AMERICA
ML-830-07-003
In Commercial Distribution

  • 00859626006282 ()
ML-830-07-003

  • Laser application software
DC Console Activation Card
MICROLIGHT CORPORATION OF AMERICA
ML-830-04-002
In Commercial Distribution

  • 00859626006190 ()
ML-830-04-002

  • Laser application software
No Description
E-SWIN
N040US000A08A
In Commercial Distribution

  • 03662824003048 ()


  • Corneal topography system analyser
No Description
E-SWIN
V040US000A08A
In Commercial Distribution

  • 03662824001846 ()


  • Corneal topography system analyser
INTEGRATED DEVICE OCULAR BIOMETER AND CORNEAL ANALYZER
VISIA IMAGING SRL
SeeNA
In Commercial Distribution

  • 08034028770470 ()
SEENA006100

  • Corneal topography system analyser
No Description
VISIA IMAGING SRL
1240213
In Commercial Distribution

  • 08034028770364 ()


  • Corneal topography system analyser
No Description
VISIA IMAGING SRL
1240212US
In Commercial Distribution

  • 08034028770333 ()
1240212US

  • Corneal topography system analyser
No Description
VISIA IMAGING SRL
TEM1240212EX
In Commercial Distribution

  • 08034028770203 ()
TEM1240212EX

  • Corneal topography system analyser
No Description
VISIA IMAGING SRL
1240400
In Commercial Distribution

  • 08034028770180 ()
1240400

  • Corneal topography system analyser
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1925
Not in Commercial Distribution

  • 04953170304965 ()


  • Digital storage media
MEDICAP USB200 DIGITAL REC
PENTAX OF AMERICA, INC.
9139
In Commercial Distribution

  • 04961333240654 ()


  • Digital storage media
MEDICAP USB 300
PENTAX OF AMERICA, INC.
9139HD
In Commercial Distribution

  • 04961333242184 ()


  • Digital storage media
KEYBOARD, SUPER MINI USB
PENTAX OF AMERICA, INC.
1111-1871
In Commercial Distribution

  • 04961333241835 ()


  • Digital storage media
The CEM Viewer for NAVIS-EX software (hereafter referred to as CEM Viewer) is used to view the examination data of the SPECULAR MICROSCOPE CEM-530 or use the data for follow-up within IMAGE FILING SOFTWARE NAVIS-EX. This function is added to the computer as a plug-in for NAVIS-EX. The examination data is displayed, analyzed, and used for follow-up. CEM Viewer can be used to display examination data on the Viewer screen or follow up data on the Follow-Up screen. The examination data is saved and managed within NAVIS-EX. The CEM Viewer data is imported to NAVIS-EX using separate software, Data Acquisition Service for NAVIS-EX.
NIDEK CO.,LTD.
1.1
In Commercial Distribution

  • 04987669607350 ()


  • Eye anterior segment analyser software
The AL-Scan Viewer for NAVIS-EX software (hereafter referred to as AL-Scan Viewer) is used to handle the AL-Scan data within NAVIS-EX. This function is added to the computer as a plug-in for NAVISEX. The measured value data and waveform can be displayed, the IOL power can be calculated, and the toric lens assist data can be created. The AL-Scan data is imported to NAVIS-EX using separate software, Data Acquisition Service.
NIDEK CO.,LTD.
1.3
In Commercial Distribution

  • 04987669200773 ()


  • Eye anterior segment analyser software
Data Acquisition Service for NAVIS-EX (hereafter referred to as DAS) acquires data from measurement devices and transfers it to NAVIS-EX. In addition to acquisition of measurement data, DAS registers patients newly registered with the ALScan/CEM-530 to NAVIS-EX.
NIDEK CO.,LTD.
1.0
In Commercial Distribution

  • 04987669101421 ()


  • Eye anterior segment analyser software
The AL-Scan Viewer for NAVIS-EX software (hereafter referred to as AL-Scan Viewer) is used to handle the AL-Scan data within NAVIS-EX. This function is added to the computer as a plug-in for NAVISEX. The measured value data and waveform can be displayed, the IOL power can be calculated, and the toric lens assist data can be created. The AL-Scan data is imported to NAVIS-EX using separate software, Data Acquisition Service.
NIDEK CO.,LTD.
1.1
In Commercial Distribution

  • 04987669101360 ()


  • Eye anterior segment analyser software
The CEM Viewer for NAVIS-EX software (hereafter referred to as CEM Viewer) is used to view the examination data of the SPECULAR MICROSCOPE CEM-530 or use the data for follow-up within IMAGE FILING SOFTWARE NAVIS-EX. This function is added to the computer as a plug-in for NAVIS-EX. The examination data is displayed, analyzed, and used for follow-up. CEM Viewer can be used to display examination data on the Viewer screen or follow up data on the Follow-Up screen. The examination data is saved and managed within NAVIS-EX. The CEM Viewer data is imported to NAVIS-EX using separate software, Data Acquisition Service for NAVIS-EX.
NIDEK CO.,LTD.
1.1
In Commercial Distribution

  • 04987669101353 ()


  • Eye anterior segment analyser software
ALLEGRETTO WAVE EYE-Q EXCIMER
Alcon Laboratories, Inc.
8065990817
Not in Commercial Distribution

  • 00380659908170 ()
8065990817

  • Laser application software
WAVENET PLANNING SOFTWARE
Alcon Laboratories, Inc.
8065000456
In Commercial Distribution

  • 00380650004567 ()


  • Laser application software
No Description
Heidelberg Engineering GmbH
Software V.1.5 US
In Commercial Distribution

  • 04059237000952 ()


  • Eye anterior segment analyser software
Data logger for Bravo Chamber Autoclave
Scican Ltd
01-111730
In Commercial Distribution

  • 07540196002394 ()
01-111730

  • Digital storage media
Data logger for Bravo Chamber Autoclave
Scican Ltd
01-111729
In Commercial Distribution

  • 07540196002387 ()
01-111729

  • Digital storage media
Data logger for Statim Cassette Autoclaves and Hydrim Instrument Washers
Scican Ltd
01-111770
In Commercial Distribution

  • 07540196000963 ()
01-111770

  • Digital storage media
KIT MMT-7306 USB CARELINK 2.4 RF INSERT
MEDTRONIC MINIMED, INC.
MMT-7306
In Commercial Distribution

  • 00763000253325 ()


  • Digital storage media
Spine System Software
Fusion Robotics, LLC
5005
In Commercial Distribution

  • 00850026574364 ()


  • Robotic surgical navigation system application software
ORTHOMAP¿ 3D 2.0 - PLANNING
Stryker Leibinger GmbH & Co. KG
6005-661-000
In Commercial Distribution

  • 04546540651624 ()
6005-661-000

  • Robotic surgical navigation system application software
ORTHOMAP¿ 3D 2.0 SOFTWARE
Stryker Leibinger GmbH & Co. KG
6005-660-000
In Commercial Distribution

  • 04546540651600 ()
6005-660-000

  • Robotic surgical navigation system application software
FLUOROSCOPY SOFTWARE 2.3
Stryker Leibinger GmbH & Co. KG
6004-650-000
In Commercial Distribution

  • 04546540505712 ()
6004-650-000

  • Robotic surgical navigation system application software
ORTHOMAP¿ EXPRESS KNEE 2.0 SOFTWARE
Stryker Leibinger GmbH & Co. KG
6003-672-000
In Commercial Distribution

  • 04546540717450 ()
6003-672-000

  • Robotic surgical navigation system application software
ORTHOMAP¿ PRECISION KNEE 5.0 SOFTWARE
Stryker Leibinger GmbH & Co. KG
6003-655-000
In Commercial Distribution

  • 04546540717443 ()
6003-655-000

  • Robotic surgical navigation system application software
CRANIALMAP(TM) NEURO
Stryker Leibinger GmbH & Co. KG
6000-655-000
In Commercial Distribution

  • 04546540717429 ()
6000-655-000

  • Robotic surgical navigation system application software
"The E-LINK Upper Limb Exerciser is designed for active and active resistive upper extremity exercise of the wrist, forearm, elbow, and shoulder. The versatility of the parameters allows rehabilitation for a wide range of orthopedic and neurological patients. The Upper Limb Exerciser is available with either a wireless or wired interface to the computer."
BIOMETRICS LIMITED
E4000
In Commercial Distribution

  • 05060481690010 ()


  • Electronic torsional hand exerciser
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