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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WAVENET PLANNING SOFTWARE
Alcon Laboratories, Inc.
8065000456
In Commercial Distribution

  • 00380650004567 ()


  • Laser application software
ALLEGRETTO WAVE EYE-Q EXCIMER
Alcon Laboratories, Inc.
8065990817
Not in Commercial Distribution

  • 00380659908170 ()
8065990817

  • Laser application software
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1925
Not in Commercial Distribution

  • 04953170304965 ()


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

  • 04961333240654 ()


  • Digital storage media
INSTALL CD,WS 3.68,OPM,US
JOHNSON & JOHNSON SURGICAL VISION, INC.
0070-2533
Not in Commercial Distribution

  • 05050474591905 ()
0070-2533

  • Laser application software
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
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
No Description
KONAN MEDICAL, INC.
Cellchek
Not in Commercial Distribution

  • 04582275250428 ()


  • 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
No Audio Remote Network Station with Dell OptiPlex 24” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-7450
In Commercial Distribution

  • 00851725007160 ()
RNS-6804-7450

  • Centralized patient monitor
No Audio Remote Network Station with Dell Inspiron 24” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6804-3464
In Commercial Distribution

  • 00851725007146 ()
RNS-6804-3464

  • Centralized patient monitor
No Audio Remote Network Station with Dell OptiPlex 7460 All-In-One Computer
NIHON KOHDEN AMERICA, INC.
RNS-6804-7460
Not in Commercial Distribution

  • 00841983104183 ()
RNS-6804-7460

  • Centralized patient monitor
Spine System Software
Fusion Robotics, LLC
5005
In Commercial Distribution

  • 00850026574364 ()


  • 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
No Description
ECENTIAL ROBOTICS
L60018
In Commercial Distribution

  • 03701311501497 ()


  • Robotic surgical navigation system application software
No Description
ECENTIAL ROBOTICS
L60017
In Commercial Distribution

  • 03701311501480 ()


  • Robotic surgical navigation system application software
No Description
ECENTIAL ROBOTICS
L00016
In Commercial Distribution

  • 03701311500445 ()


  • Robotic surgical navigation system application software
SOFTWARE INTEGRATION BROKER HL7
Smith & Nephew, Inc.
72201079
Not in Commercial Distribution

  • 03596010589637 ()
72201079

  • Robotic surgical navigation system application software
INTEGRATION SOFTWARE BROKER, DICOM
Smith & Nephew, Inc.
72201081
In Commercial Distribution

  • 03596010588371 ()
72201081

  • Robotic surgical navigation system application software
INTEGRATION BROKER ANNUAL SUPPORT DICO
Smith & Nephew, Inc.
72201082
In Commercial Distribution

  • 03596010588388 ()
72201082

  • Robotic surgical navigation system application software
ORTHOPILOT SOFTWARE ACL SGL.+DBL.BUNDLE
Aesculap AG
FS227
Not in Commercial Distribution

  • 04046963895860 ()
FS227

  • Robotic surgical navigation system application software
ORTHOPILOT SOFTWARE TKA VEGA
Aesculap AG
FS226
Not in Commercial Distribution

  • 04046963895853 ()
FS226

  • Robotic surgical navigation system application software
ORTHOPILOT SOFTWARE THA ACA
Aesculap AG
FS229
Not in Commercial Distribution

  • 04046963989101 ()
FS229

  • Robotic surgical navigation system application software
ORTHOPILOT SOFTWARE TKA SMART
Aesculap AG
FS228
Not in Commercial Distribution

  • 04046963977979 ()
FS228

  • Robotic surgical navigation system application software
The Navigant Navigation Workstation (NWS) is a component of the Magnetic Navigation System (MNS). The MNS with NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant feature provides an enhanced navigation interface for the physician to control the MNS.
Stereotaxis, Inc.
5.1.0
In Commercial Distribution

  • M588020004500370 ()
020-004500-37

  • Robotic surgical navigation system application software
The Navigant Navigation Workstation is a component of the Niobe MNS. The Niobe MNS with NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant feature provides an enhanced navigation interface for the physician to control the MNS
Stereotaxis, Inc.
5.0.2
In Commercial Distribution

  • M588020004500260 ()
020-004500-26

  • Robotic surgical navigation system application software
The Navigant Navigation Workstation is a component of the Niobe MNS. The Niobe MNS with NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant feature provides an enhanced navigation interface for the physician to control the MNS
Stereotaxis, Inc.
4.6.5
In Commercial Distribution

  • M588020004500220 ()
020-004500-22

  • Robotic surgical navigation system application software
The Navigant Navigation Workstation is a component of the Niobe MNS. The Niobe MNS with NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant feature provides an enhanced navigation interface for the physician to control the MNS
Stereotaxis, Inc.
4.6.4
In Commercial Distribution

  • M588020004500210 ()
020-004500-21

  • Robotic surgical navigation system application software
ORTHOPILOT SOFTWARE ACL
Aesculap AG
FS215
Not in Commercial Distribution

  • 04038653423316 ()
FS215

  • Robotic surgical navigation system application software
ORTHOPILOT SOFTWARE THA PLUS
Aesculap AG
FS217
In Commercial Distribution

  • 04046963181901 ()
FS217

  • Robotic surgical navigation system application software
ORTHOPILOT SOFTWARE COLUMBUS TKR
Aesculap AG
FS222
Not in Commercial Distribution

  • 04046963492083 ()
FS222

  • Robotic surgical navigation system application software
ORTHOPILOT SOFTWARE THA CUP ONLY
Aesculap AG
FS219
Not in Commercial Distribution

  • 04046963372446 ()
FS219

  • Robotic surgical navigation system application software
Disk Image for CF532S
Omni Life Science, Inc.
NS-27013
In Commercial Distribution

  • 00841690194477 ()
NS-27013

  • Robotic surgical navigation system application software
ART Knee Software Rev 2.4.0
Omni Life Science, Inc.
NS-27014
In Commercial Distribution

  • 00841690194460 ()
NS-27014

  • Robotic surgical navigation system application software
OMNIBotics Application System Rev 2.3.0
Omni Life Science, Inc.
NS-27015
In Commercial Distribution

  • 00841690194453 ()
NS-27015

  • Robotic surgical navigation system application software
ART Knee Software Rev 2.5.0
Omni Life Science, Inc.
NS-27016
In Commercial Distribution

  • 00841690194446 ()
NS-27016

  • Robotic surgical navigation system application software
ART Knee Software Rev 2.6.0
Omni Life Science, Inc.
NS-27017
In Commercial Distribution

  • 00841690194439 ()
NS-27017

  • Robotic surgical navigation system application software
Software Package, ART Knee 2.7
Omni Life Science, Inc.
NS-27114
In Commercial Distribution

  • 00841690194392 ()
NS-27114

  • Robotic surgical navigation system application software
ART Knee Software unitary component
Omni Life Science, Inc.
0770-2000
In Commercial Distribution

  • 00841690194712 ()
0770-2000

  • Robotic surgical navigation system application software
Technical Core Library
Omni Life Science, Inc.
2202-2000
In Commercial Distribution

  • 00841690194705 ()
2202-2000

  • Robotic surgical navigation system application software
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