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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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CoroFlow Upgrade kit - 07350111070663

Software upgrade for Coroventis CoroFlow System
COROVENTIS Research AB
12000-20
In Commercial Distribution

  • 07350111070663 ()


  • Cardiac catheterization laboratory computer

Site~Rite 8 - 00801741121449

Site~Rite 8 Ultrasound System Software
Bard Access Systems, Inc.
SR8v1.0.3
In Commercial Distribution

  • 00801741121449 ()
SR8v1.0.3

  • General-purpose ultrasound imaging system

Phadia Information Data Manager Software Package - 07333066001012

Phadia Information Data Manager Software Package
Phadia AB
12-3801-11
In Commercial Distribution

  • 07333066001012 ()
12-3801-11

  • Laboratory instrument/analyser application software IVD

Site~Rite 8 Ultrasound System - 00801741225895

Site~Rite 8 Software v. 3.0.1
Bard Access Systems, Inc.
SR8v3.0.1
In Commercial Distribution

  • 00801741225895 ()
SR8v3.0.1

  • General-purpose ultrasound imaging system

Site~Rite 8 - 00801741219436

Site~Rite 8 Sherlock Application Software
Bard Access Systems, Inc.
Sherlockv3.1.1
In Commercial Distribution

  • 00801741219436 ()
Sherlockv3.1.1

  • Central venous catheter navigation system, electrocardiographic/magnetic

Site~Rite 8 - 00801741219252

Site~Rite 8 Ultrasound Application Software
Bard Access Systems, Inc.
SR8 USv2.2.0
In Commercial Distribution

  • 00801741219252 ()
SR8 USv2.2.0

  • General-purpose ultrasound imaging system

Site~Rite 8 Ultrasound System - 00801741219382

Site~Rite 8 Software v. 2.3.1
Bard Access Systems, Inc.
SR8v2.3.1
In Commercial Distribution

  • 00801741219382 ()
SR8v2.3.1

  • General-purpose ultrasound imaging system

Site~Rite 8 - 00801741219344

Site~Rite 8 Host System Software
Bard Access Systems, Inc.
SR8v2.2.0
In Commercial Distribution

  • 00801741219344 ()
SR8v2.2.0

  • General-purpose ultrasound imaging system

Aurora Xi Plasmapheresis System - 00810020440898

Software Version 1.3 for Aurora Xi
Fresenius Kabi AG
1.3
In Commercial Distribution

  • 00810020440898 ()


  • Apheresis system

Aurora Plasmapheresis System Software Version 2.1 - 00810020440003

Aurora Plasmapheresis System Software Version 2.1
Fresenius Kabi AG
SW 2.1
In Commercial Distribution

  • 00810020440003 ()
  • 10810020440000 ()


  • Apheresis system

N/A - 00763000975029

SOFTWARE APP A610 DBS CLINICIAN V5.0
MEDTRONIC, INC.
A610
In Commercial Distribution

  • 00763000975029 ()


  • Multiple active implantable device programmer

OrthoNext™ Platform System Software - 18052469476444

POSTOPERATIVE TLHEX MODULE FOR ORTHONEXT SOFTWARE
ORTHOFIX SRL
1.0
In Commercial Distribution

  • 18052469476444 ()
TLHEXMODULESW

  • Radiological PACS software

Werewolf - 00885556692516

WEREWOLF MAIN SOFTWARE UPGRADE V. 2.5-1.4
Smith & Nephew, Inc.
72290133
In Commercial Distribution

  • 00885556692516 ()
72290133

  • Electrosurgical system generator

Cytomics FC500 - 15099590572839

Cytomics FC 500 with CXP Software
Beckman Coulter, Inc.
UPS (CXP)
In Commercial Distribution

  • 15099590572839 ()
626553

  • Flow cytometry analyser IVD, semi-automated

Earlens Wireless Programmer - 00850013007110

Software version is in Application Identifier (8012) Lot Number reflects software assembly/packaging lot number
EARLENS CORPORATION
WPUSB01
Not in Commercial Distribution

  • 00850013007110 ()
WPUSB01

  • Hearing aid/implant system programming interface unit

VITEK®2 - 03573026553968

VITEK ® 2 software 8.01 update, advanced software to run your VITEK ® 2 system
BIOMERIEUX , INC.
8.01
In Commercial Distribution

  • 03573026553968 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD

360CAS - B432360CAS2100

360CAS Navigation System Software is a bespoke software developed by Kico for surgical navigation. The software contains two modules, 360CAS Knee and 360CAS Hip.
KICO KNEE INNOVATION COMPANY PTY LIMITED
2.1.0
In Commercial Distribution

  • B432360CAS2100 ()


  • Robotic surgical navigation system application software

NeuroMatch - 00850056774000

NeuroMatch is a Software as Medical Device intended for physicians to review EEG data.
LVIS CORPORATION
1.0.4
In Commercial Distribution

  • 00850056774000 ()


  • Bioelectrical signal analysis software

Persyst 15 EEG Review and Analysis Software - 00869732000166

Persyst 15 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
Persyst Development Corp
P15
In Commercial Distribution

  • 00869732000166 ()


  • Bioelectrical signal analysis software

Persyst Mobile App - 00869732000142

This is an application intended to be used by neurologists who are monitoring or reviewing EEGs. It is part of a larger system provided by Persyst.
Persyst Development Corp
App for Web
Not in Commercial Distribution

  • 00869732000142 ()


  • Bioelectrical signal analysis software
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