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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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Care Orchestrator, Medical equipment clinical data interfacing software
Respironics, Inc.
1.24
In Commercial Distribution

  • 00606959057760 ()
1126366

  • Medical equipment clinical data interfacing software
Care Orchestrator, Medical equipment clinical data interfacing software
Respironics, Inc.
1.23
In Commercial Distribution

  • 00606959057500 ()
1126366

  • Medical equipment clinical data interfacing software
VolparaDensity 3.3 (Volpara Imaging Software 1.5.3 and 1.5.4)
VOLPARA HEALTH TECHNOLOGIES LIMITED
3.3
In Commercial Distribution

  • 09421904268098 ()


  • Radiology DICOM image processing application software
Source Localization Software For Electroencephalograph Or Magnetoencephalograph Electroencephalograph.
ELECTRICAL GEODESICS, INC.
GeoSource 2.0
Not in Commercial Distribution

  • 00863003000343 ()


  • Electroencephalograph
Welch Allyn Connex Central Station Software; v 1.5
WELCH ALLYN, INC.
901066
In Commercial Distribution

  • 00732094195408 ()
1000994

  • Centralized patient monitor
Welch Allyn Diagnostic Cardiology Suite Spirometry; Software Only
WELCH ALLYN, INC.
901128
In Commercial Distribution

  • 00732094323993 ()
DCSS-SXA

  • Diagnostic spirometer, professional
Computer workstation used in conjunction with TeleRehab software.
SCOTTCARE CORPORATION, THE
TeleRehab Computer
In Commercial Distribution

  • 00856298006275 ()
101819

  • Desktop computer
Platform software application for data collection and analysis
PREVENTICE TECHNOLOGIES, INC.
SW1001
In Commercial Distribution

  • 00852132007286 ()


  • Cardiopulmonary physiological parameter analysis software
Medical software used for oximetry analysis and reporting.
APNEICARE, LLC
CCIA
In Commercial Distribution

  • G642CC1A0 ()


  • Medical equipment clinical data interfacing software
Software Module for RITA Model 1500X RF Generator
ANGIODYNAMICS, INC.
700-104918
In Commercial Distribution

  • H7877001049180 ()
  • 15051684021876 ()


  • Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar
Radiochromic film dosimetry and radiation therapy QA software
RADIOCHROMIC SL.
5.1
In Commercial Distribution

  • B9875X10 ()


  • Accelerator system quality assurance device
Radiochromic film dosimetry and radiation therapy QA software
RADIOCHROMIC SL.
5.0
Not in Commercial Distribution

  • B9875X00 ()


  • Accelerator system quality assurance device
Radiochromic film dosimetry and radiation therapy QA software
RADIOCHROMIC SL.
4.0
Not in Commercial Distribution

  • B9874X00 ()


  • Accelerator system quality assurance device
Radiochromic film dosimetry and radiation therapy QA software
RADIOCHROMIC SL.
3.4
Not in Commercial Distribution

  • B9873X40 ()


  • Accelerator system quality assurance device
Radiochromic film dosimetry and radiation therapy QA software
RADIOCHROMIC SL.
3.3
Not in Commercial Distribution

  • B9873X30 ()


  • Accelerator system quality assurance device
Cloud-based mBCA software for diagnosis and therapy support.
seca GmbH & Co. KG
125
Not in Commercial Distribution

  • 04012030021678 ()
1252000020

  • Medical equipment clinical data interfacing software
Cloud-based mBCA software for diagnosis and therapy support.
seca GmbH & Co. KG
125
Not in Commercial Distribution

  • 04012030020794 ()
1252000012

  • Medical equipment clinical data interfacing software
Cloud-based mBCA software for diagnosis and therapy support.
seca GmbH & Co. KG
125
Not in Commercial Distribution

  • 04012030020503 ()
1252000010

  • Medical equipment clinical data interfacing software
Cloud-based mBCA software for diagnosis and therapy support.
seca GmbH & Co. KG
125
In Commercial Distribution

  • 04012030022910 ()
1252000030

  • Medical equipment clinical data interfacing software
LABSYSTEM™ PRO EP Review Workstation Software, V2.7
BOSTON SCIENTIFIC CORPORATION
M00420020300
In Commercial Distribution

  • 08714729884002 ()


  • Cardiopulmonary physiological parameter analysis software
BD Pyxis MedBank Tower (MedPass Software v1.X)
CAREFUSION 303, INC.
SW-MP-V1
In Commercial Distribution

  • 10885403513817 ()


  • Anaesthesia cabinet
BD Pyxis Anesthesia Station 4000 (Software v6.X)
CAREFUSION 303, INC.
SW-PAS-4000-V6
In Commercial Distribution

  • 10885403513787 ()


  • Anaesthesia cabinet
BD Pyxis Anesthesia Station ES (Software v2.X)
CAREFUSION 303, INC.
SW-PAS-ES-V2
In Commercial Distribution

  • 10885403513770 ()


  • Anaesthesia cabinet
BioPlex 2200 System Operation Manual , Software Version 4.3
BIO-RAD LABORATORIES, INC.
SW Version 4.3
In Commercial Distribution

  • 03610520540633 ()

  • 1 EA
12000958

  • Fluorescent immunoassay analyser IVD, laboratory
BioPlex 2200 System Operation Manual , Software Version 4.2
BIO-RAD LABORATORIES, INC.
SW Version 4.2
In Commercial Distribution

  • 03610520505915 ()

  • 1 EA
6600813-4.2.1

  • Fluorescent immunoassay analyser IVD, laboratory
Lot Number reflects software assembly/packaging lot number
EARLENS CORPORATION
EWU01
Not in Commercial Distribution

  • 08500130070000 ()
EWU01

  • Hearing aid/implant system programming interface unit
VIDAS PC V4.9 W10 Software version for clinic
BIOMERIEUX SA
4.9
In Commercial Distribution

  • 03573026619527 ()


  • Fluorescent immunoassay analyser IVD, laboratory
FONA CDR DICOM 4.5 SOFTWARE - MULTI USER (ENGLISH)
SIRONA DENTAL, INC.
B1035106
In Commercial Distribution

  • D764B10351060 ()


  • Diagnostic x-ray digital imaging system workstation application software
4Klearity Med X Change Brand Software Version 7.12.1.2
Nds Surgical Imaging LLC
4KR100
Not in Commercial Distribution

  • 00817613021021 ()


  • Endoscopic video image processing unit
NAVIPLAN, CT Planning Software for Total Hip Replacement
Naviswiss AG
NS053
In Commercial Distribution

  • 07640176970535 ()


  • Orthopaedic/craniofacial implantation planning software
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