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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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BD Pyxis MedStation 4000 (Software v7.X)
CAREFUSION 303, INC.
SW-MS-4000-V7
In Commercial Distribution

  • 10885403513749 ()


  • Anaesthesia cabinet
BD Pyxis CIISafe ES (Software v1.X)
CAREFUSION 303, INC.
SW-CII-SAFE-ES-V1
In Commercial Distribution

  • 10885403513732 ()


  • Anaesthesia cabinet
Arial Software Client w/ Desktop PC Bundle
Securitas Healthcare LLC
54390
In Commercial Distribution

  • 00840948102721 ()
54390

  • Fixed call button
NOEMODE 2.0 SOFTWARE, FINISHED GOOD, FACTORY INSTALL
Covidien LP
10122274
Not in Commercial Distribution

  • 10884521609181 ()


  • Ventilator application software
AIDA compact II Software Upgrade (v.2.4
Karl Storz GmbH & Co. KG
20040502-U02
In Commercial Distribution

  • 04048551060049 ()


  • Operating room audiovisual data/device management system application software
AIDA compact II Software HD (v.2.3)
Karl Storz GmbH & Co. KG
20040402-15
In Commercial Distribution

  • 04048551032558 ()


  • Operating room audiovisual data/device management system application software
SOFTWARE KIT,VMAX ENCORE VERSION 20-5B CD
Carefusion Corporation
63654
Not in Commercial Distribution

  • 10846446027600 ()
63654

  • Pulmonary function analysis system, paediatric
  • Pulmonary function analysis system, adult
LABSYSTEM™ PRO EP Review Workstation Software
BOSTON SCIENTIFIC CORPORATION
M004LSPRO400100
In Commercial Distribution

  • 00191506004392 ()
M004LSPRO400100

  • Cardiopulmonary physiological parameter analysis software
USB Stick containing Mag Log Converter Software
Thoratec Switzerland GmbH
201-52213
In Commercial Distribution

  • 07640135140566 ()
201-52213

  • Circulatory assist system application software
Lumax™ TS Pro Advanced • Software Kit
Coopersurgical, Inc.
23486
In Commercial Distribution

  • 60888937013391 ()


  • Urodynamic measurement system
Scopis ENT Software with Target Guided Surgery
Stryker Leibinger GmbH & Co. KG
8000-020-002
In Commercial Distribution

  • 07613327413199 ()
8000-020-002

  • Stereotactic system application software
Clinician Programmer Software for H200 Wireless System
Bioness Medical, Inc.
H2W-SW01
In Commercial Distribution



  • Hand orthosis
Clinician Programmer Software for L300 Go System
Bioness Medical, Inc.
LG4-SW01
In Commercial Distribution



  • Gait-enhancement electrical stimulation system, external
Zvu® Functional GI Software Revision 3.4.0
DIVERSATEK HEALTHCARE, INC.
ZVU-3 Revision 3.4.0
In Commercial Distribution

  • 00816734023426 ()
ZVU-3

  • Manometric gastrointestinal motility analysis system
GoCheck Kids Native Software Application for Nokia.
Gobiquity, Inc.
Nokia 4.6.3
In Commercial Distribution

GCKNOK463

  • External ocular measurement camera
Clinician Programmer Software for L300 Go system
BIONESS INC.
LG4-SW01
In Commercial Distribution

  • 00815962020061 ()


  • Gait-enhancement electrical stimulation system, external
Esteem® Commander™ Software Version 3.0
Envoy Medical Corporation
6002
In Commercial Distribution

  • 00812282020504 ()
006002-002

  • Fully-implantable middle ear implant system
Esteem® Commander™ Software Version 2.2
Envoy Medical Corporation
6001
In Commercial Distribution

  • 00812282020481 ()
003873-010

  • Fully-implantable middle ear implant system
Intraoperative System Analyzer (ISA), Software Version 9.0
Envoy Medical Corporation
3001
In Commercial Distribution

  • 00812282020429 ()
004652-005

  • Fully-implantable middle ear implant system
Intraoperative System Analyzer (ISA), Software and Computer
Envoy Medical Corporation
3001
In Commercial Distribution

  • 00812282020160 ()
903001-003

  • Fully-implantable middle ear implant system
Site~Rite 8 Ultrasound System Host Software
Bard Access Systems, Inc.
SR8 USv2.1.0
In Commercial Distribution

  • 00801741161094 ()
SR8 USv2.1.0

  • General-purpose ultrasound imaging system
PillCam™ Software v9.0 for WS, USA
Given Imaging, Inc.
FGS-0637
In Commercial Distribution

  • 07290110360191 ()


  • Video capsule endoscopy system application software
Site~Rite 9 Ultrasound Software v.1.2.0
Bard Access Systems, Inc.
SR9v1.2.0
In Commercial Distribution

  • 00801741231186 ()
SR9v1.2.0

  • Central venous catheter navigation system, electrocardiographic/magnetic
  • General-purpose ultrasound imaging system
Site Rite 8 Ultrasound System Application Software
Bard Access Systems, Inc.
SR8v2.4.0
In Commercial Distribution

  • 00801741219405 ()
SR8v2.4.0

  • General-purpose ultrasound imaging system
Software version for AMICUS Separator Legacy Device
Fresenius Kabi AG
6.1.51.0
In Commercial Distribution

  • 00810020441208 ()


  • Apheresis system
Software version for AMICUS Separator Legacy Device
Fresenius Kabi AG
6.1.13.0
In Commercial Distribution

  • 00810020440591 ()


  • Apheresis system
NAVIOS EX TETRA SOFTWARE V2.0 NEW USER
BECKMAN COULTER IRELAND INC.
TETRA SOFTWARE V2.0 NEW USER
In Commercial Distribution

  • 15099590683276 ()
B91240

  • Laboratory instrument/analyser application software IVD
BT12 ECG AHA WITH SPIROTRAC 6 SOFTWARE
VITALOGRAPH (IRELAND) LIMITED
4130
In Commercial Distribution

  • 05099169413337 ()
  • 15099169413334 ()


  • Electrocardiograph, professional, multichannel
BT-12 ECG IEC with SPIROTRAC 6 SOFTWARE
VITALOGRAPH (IRELAND) LIMITED
4130
In Commercial Distribution

  • 05099169413306 ()
  • 15099169413303 ()


  • Electrocardiograph, professional, multichannel
Cytomics FC 500 MPL with MXP Software
Beckman Coulter, Inc.
UPS (MPL)
In Commercial Distribution

  • 15099590572822 ()
626554

  • Flow cytometry analyser IVD, semi-automated
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