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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Infusion Safety Management Software
ICU MEDICAL, INC.
2.1
In Commercial Distribution

  • 00887709122819 ()
17005-01

  • Medical equipment clinical data interfacing software
Infusion Safety Management Software
ICU MEDICAL, INC.
2.1
In Commercial Distribution

  • 00887709122802 ()
17003-01

  • Infusion pump medication-dosage application software
SiteRite 9 Sherlock Software
Bard Access Systems, Inc.
Sherlockv3.3.0
In Commercial Distribution

  • 00801741219214 ()
Sherlockv3.3.0

  • General-purpose ultrasound imaging system
  • Central venous catheter navigation system, electrocardiographic/magnetic
Blue Sky Plan Software
BLUE SKY BIO LLC
4.13
In Commercial Distribution

  • 00810060226063 ()
BSP

  • Dental treatment application software
Cardiac PET Processing Software
Bracco Diagnostics Inc.
1.00
In Commercial Distribution

  • 30815112020584 ()
001771

  • Image segmentation application software
AR v3.0 Software kit
Given Imaging, Inc.
FGS-8030
In Commercial Distribution

  • 07290101365785 ()


  • Manometric gastrointestinal motility analysis system
ORTHONEXT SOFTWARE VERSION 2.1
ORTHOFIX SRL
2.1
In Commercial Distribution

  • 18059015375831 ()
ORTHONEXTSW2.1

  • Radiological PACS software
ManoView ESO Software v3.3
Given Imaging, Inc.
FGS-0628
In Commercial Distribution

  • 07290101369578 ()


  • Manometric gastrointestinal motility analysis system
PillCam Software v9.0, USA
Given Imaging, Inc.
FGS-0612
In Commercial Distribution

  • 07290101366751 ()


  • Video capsule endoscopy system application software
CLT v3.0 software upgrade
Given Imaging, Inc.
FGS-0580
In Commercial Distribution

  • 07290101366102 ()


  • Manometric gastrointestinal motility analysis system
v3.0 software kit upgrade
Given Imaging, Inc.
FGS-0573
In Commercial Distribution

  • 07290101365945 ()


  • Manometric gastrointestinal motility analysis system
CLT v3.0 software kit
Given Imaging, Inc.
FGS-0572
In Commercial Distribution

  • 07290101365938 ()


  • Manometric gastrointestinal motility analysis system
Infusion Safety Management Software
BAXTER HEALTHCARE CORPORATION
1.9
In Commercial Distribution

  • 20085412676610 ()
DOSEIQW0001

  • Infusion pump medication-dosage application software
AutoCAT2 Modem Connection Software
TELEFLEX INCORPORATED
IPN000284
In Commercial Distribution

  • 00801902084859 ()
IAM-2004

  • Intra-aortic balloon pump
Reflux software v6.1 upgrade
Given Imaging, Inc.
FGS-0657
In Commercial Distribution

  • 07290110360436 ()


  • Gastrointestinal telemetric monitoring system
SOFTWARE 9735585 STEALTHSTATION CRANIAL
MEDTRONIC NAVIGATION, INC.
9735585
In Commercial Distribution

  • 00763000253165 ()


  • Neurological stereotactic surgery system
PRODUCT SOFTWARE MMT-7350 V2.2A
MEDTRONIC MINIMED, INC.
MMT-7350
In Commercial Distribution

  • 00763000242787 ()


  • Patient health record information system application software
SOFTWARE 5242 TRIAGEHF US
MEDTRONIC, INC.
5242
In Commercial Distribution

  • 00763000351656 ()


  • Implantable cardiac device management application software
CT Image Post-Processing Software
Shanghai United Imaging Healthcare Co., Ltd.
uWS-CT
In Commercial Distribution

  • 06971576834020 ()


  • Radiology DICOM image processing application software
MR Image Post-Processing Software
Shanghai United Imaging Healthcare Co., Ltd.
uWS-MR
In Commercial Distribution

  • 06971576834013 ()


  • MRI system application software
TELLIGENCE BRIDGE SOFTWARE V7.0
Ascom (Sweden) AB
NGTELL70-S
In Commercial Distribution

  • 17350088671396 ()


  • Nurse call system
TELLIGENCE BRIDGE SOFTWARE V6.4
Ascom (Sweden) AB
NGTELL64-S
In Commercial Distribution

  • 17350088671372 ()


  • Nurse call system
TELLIGENCE BRIDGE SOFTWARE V6.3
Ascom (Sweden) AB
NGTELL63-S
In Commercial Distribution

  • 17350088671297 ()


  • Nurse call system
TELLIGENCE BRIDGE SOFTWARE V5.2
Ascom (Sweden) AB
NGTELL52-S
In Commercial Distribution

  • 17350088671266 ()


  • Nurse call system
TELLIGENCE BRIDGE SOFTWARE V6.2
Ascom (Sweden) AB
NGTELL62-S
In Commercial Distribution

  • 17350088671259 ()


  • Nurse call system
TELLIGENCE BRIDGE SOFTWARE V6.1
Ascom (Sweden) AB
NGTELL61-S
In Commercial Distribution

  • 17350088671167 ()


  • Nurse call system
TELLIGENCE BRIDGE SOFTWARE V5.3
Ascom (Sweden) AB
NGTELL53-S
In Commercial Distribution

  • 17350088670887 ()


  • Nurse call system
TELLIGENCE BRIDGE SOFTWARE V6.9
Ascom (Sweden) AB
NGTELL69-S
In Commercial Distribution

  • 17350088670870 ()


  • Nurse call system
TELLIGENCE BRIDGE SOFTWARE V6.10
Ascom (Sweden) AB
NGTELL610-S
In Commercial Distribution

  • 17350088670825 ()


  • Nurse call system
TELLIGENCE BRIDGE SOFTWARE V6.8
Ascom (Sweden) AB
NGTELL68-S
In Commercial Distribution

  • 17350088670740 ()


  • Nurse call system
TELLIGENCE BRIDGE SOFTWARE V6.6
Ascom (Sweden) AB
NGTELL66-S
In Commercial Distribution

  • 17350088670726 ()


  • Nurse call system
TELLIGENCE BRIDGE SOFTWARE V6.5
Ascom (Sweden) AB
NGTELL65-S
In Commercial Distribution

  • 17350088670719 ()


  • Nurse call system
TELLIGENCE BRIDGE SOFTWARE V5.1
Ascom (Sweden) AB
NGTELL51-S
Not in Commercial Distribution

  • 17350088670610 ()


  • Nurse call system
TELLIGENCE BRIDGE SOFTWARE V5.0
Ascom (Sweden) AB
NGTELL50-S
Not in Commercial Distribution



  • Nurse call system
TELLIGENCE BRIDGE SOFTWARE V4.1
Ascom (Sweden) AB
NGTELL41-S
In Commercial Distribution



  • Nurse call system
TELLIGENCE BRIDGE SOFTWARE V4.0
Ascom (Sweden) AB
NGTELL40-S
In Commercial Distribution

  • 17350088670368 ()


  • Nurse call system
R.I.KNEE 2.1 SOFTWARE KIT
Smith & Nephew, Inc.
ROB10405
In Commercial Distribution

  • 00885556798027 ()
ROB10405

  • Robotic surgical arm system
ARIA HOME PT SOFTWARE
Smith & Nephew, Inc.
SSK1
In Commercial Distribution

  • 00885556803868 ()
SSK1

  • Virtual-display rehabilitation system, non-supportive, clinical
SOFTWARE 9735585 STEALTHSTATION CRANIAL
MEDTRONIC NAVIGATION, INC.
9735585
In Commercial Distribution

  • 00763000095741 ()


  • Neurological stereotactic surgery system
SOFTWARE LENS TABLET APPLICATION
Smith & Nephew, Inc.
72204699
In Commercial Distribution

  • 00885556653876 ()
72204699

  • Endoscopic video imaging system
SOFTWARE, 9732430, SPINE UNIFIED
MEDTRONIC NAVIGATION, INC.
9732430
In Commercial Distribution

  • 00885074445465 ()


  • Multi-purpose stereotactic surgery system
Q-Stress Server - version 6, current software CD; Software kit; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094308440 ()
QSERV-6AA-XXXXX

  • Electrocardiographic lead set, reusable
HScribe Server - version 6, current software CD; Software kit; No connectivity
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094263978 ()
HSERV-6AA-XXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software
Alaris Systems Maintenance v12.3-v.12.5
CAREFUSION 303, INC.
8975
In Commercial Distribution

  • 10885403897535 ()


  • Infusion pump medication-dosage application software
Alaris Guardrails Editor 12-12.1.3
CAREFUSION 303, INC.
8961
In Commercial Distribution

  • 10885403896125 ()


  • Infusion pump medication-dosage application software
Alaris Guardrails Editor 12.1.4
CAREFUSION 303, INC.
8961
In Commercial Distribution

  • 10885403520020 ()


  • Infusion pump medication-dosage application software
No Description
ICU MEDICAL, INC.
22-4095-0204-25
In Commercial Distribution

  • 15019517088632 ()


  • Infusion pump medication-dosage application software
Top and Bottom Aligners
ARCADLAB
Clear Orthodontic Aligners
In Commercial Distribution

  • 00860011071921 ()


  • Orthodontic aligner auxiliary attachment kit
Stratus EEG is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equipment that is imported into the system. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal. The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions.
Kvikna Medical ehf.
Client Software
In Commercial Distribution



  • Bioelectrical signal analysis software
Stratus EEG is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equipment that is imported into the system. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal. The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions.
Kvikna Medical ehf.
Server Software
In Commercial Distribution



  • Bioelectrical signal analysis software
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