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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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Portrait Central Viewer Application Installer v1.1.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CVAXB
In Commercial Distribution

  • 00195278656681 ()
5863721-11

  • Wireless patient monitor/sensor reporting software, professional-only
Capital equipment to support the Leaf sensor patient montitoring system
SMITH & NEPHEW MEDICAL LIMITED
66802119
In Commercial Distribution

  • 05000223499907 ()
66802119

  • Wireless patient monitor/sensor reporting software, professional-only
Capital equipment to support the Leaf sensor patient montitoring system
SMITH & NEPHEW MEDICAL LIMITED
66802118
In Commercial Distribution

  • 05000223499891 ()
66802118

  • Wireless patient monitor/sensor reporting software, professional-only
Holter Web Portal
Lifesignals, Inc.
UA2251-C
In Commercial Distribution

  • B353UA2251C1 ()


  • Wireless patient monitor/sensor reporting software, professional-only
Access Point is an accessory that enables wireless streaming to a computer for the Opal V2C.
ERESEARCHTECHNOLOGY, INC.
APV2C
In Commercial Distribution

  • 00850023837035 ()


  • Kinesiology ambulatory recorder
Ion exchange chromatography analyzer sold with lithium high performance column, LED monitor, computer, autosampler, Openlab software
BIOCHROM LIMITED
80-6000-53EZ
In Commercial Distribution

  • 05056336800239 ()


  • Amino acid analyser IVD
No Description
Carl Zeiss Meditec AG
6914
In Commercial Distribution

  • 04049539069146 ()


  • Ophthalmic surgical microscope data overlay unit
Alcon Online Barrett Toric IOL Calculator
Alcon Laboratories, Inc.
Version 2
In Commercial Distribution

  • 00380659909498 ()


  • Intraocular lens calculation software
AcrySof IQ ReSTOR Multifocal Toric IOL +2.5 D IOL Calculator
Alcon Laboratories, Inc.
Version 1
In Commercial Distribution

  • 00380659909481 ()


  • Intraocular lens calculation software
AcrySof IQ ReSTOR Multifocal Toric IOL +3.0 D IOL Calculator
Alcon Laboratories, Inc.
Version 1.0
In Commercial Distribution

  • 00380659909474 ()


  • Intraocular lens calculation software
AcrySof® IQ Toric IOL Calculator
Alcon Laboratories, Inc.
Version 3
In Commercial Distribution

  • 00380659909467 ()


  • Intraocular lens calculation software
No Description
Brainlab AG
17700
In Commercial Distribution

  • 04056481142520 ()


  • Robotic surgical navigation system
  • Electromagnetic/optical surgical navigation device tracking system
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Z319-10
In Commercial Distribution

  • 06944904090733 ()


  • DVD recorder
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-011007-00
In Commercial Distribution

  • 06944904033419 ()


  • DVD recorder
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-050177-00
In Commercial Distribution

  • 06944904098715 ()


  • DVD recorder
9250-ST Telesis® ST Software for Speech Therapy MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9250-ST
In Commercial Distribution

  • 00852423006431 ()
9250-ST

  • Biofeedback system application software
Synergy® 3-Dimensional Software for the Pathway® MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9225
In Commercial Distribution

  • 00852423006103 ()
9225

  • Biofeedback system application software
Primus® Software for the Pathway® MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9275
In Commercial Distribution

  • 00852423006097 ()
9275

  • Biofeedback system application software
Telesis® Software for the Pathway® MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9250
In Commercial Distribution

  • 00852423006080 ()
9250

  • Biofeedback system application software
No Description
NFANT LABS LLC
1
In Commercial Distribution

  • 00861410000246 ()
NA4

  • Biofeedback system application software
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