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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Software Pristina ME 9.2 - ISO file
GE MEDICAL SYSTEMS
PRISTINA ME 9.2
In Commercial Distribution

  • 00195278719812 ()


  • Mammographic x-ray system stereotactic unit
  • Stationary mammographic x-ray system, digital
PULSE Software Package including IOM, iG
Nuvasive, Inc.
8000104
In Commercial Distribution

  • 00195377099013 ()


  • Orthopaedic stereotactic surgery system
Knee Software Package, ART 2.0.1 Add-on
Omni Life Science, Inc.
NS-27007
In Commercial Distribution

  • 00841690194538 ()
NS-27007

  • Instrument tray, reusable
Knee Software Package, ART 2.2 Add-on
Omni Life Science, Inc.
NS-27009
In Commercial Distribution

  • 00841690194514 ()
NS-27009

  • Instrument tray, reusable
CDR DICOM 5.0 FOR WINDOWS SOFTWARE
SIRONA DENTAL, INC.
B1030191
In Commercial Distribution

  • D764B10301910 ()


  • Diagnostic x-ray digital imaging system workstation application software
CD 660IMS SOFTWARE UPGRADE VER 1.5
Smith & Nephew, Inc.
72201078
In Commercial Distribution

  • 03596010579591 ()
72201078

  • Endoscopic video imaging system
PCMCIA CARD SOFTWARE VERSION 3.71 VULC
Smith & Nephew, Inc.
72201356
In Commercial Distribution

  • 03596010612793 ()
72201356

  • Radio-frequency ablation system
Radixact Delivery System Software (Version 1.1)
ACCURAY INCORPORATED
1060253
In Commercial Distribution

  • M65810602530 ()
N/A

  • Linear accelerator system
Lilivis CAD L-CAD (Chairside CAD Software)
Huvitz Co., Ltd.
L-CAD
In Commercial Distribution

  • 08800019600909 ()
LS-100

  • CAD/CAM software
Monarch™ Laptop P16 Software v4.1.1
AURIS HEALTH, INC.
Version 4.1.1
In Commercial Distribution

  • 10810068811527 ()


  • Robotic surgical system application software
Monarch™ Laptop P17 Software v4.1.1
AURIS HEALTH, INC.
Version 4.1.1
In Commercial Distribution

  • 10810068811510 ()


  • Robotic surgical system application software
Monarch™ Laptop P16 Software v4.1.0
AURIS HEALTH, INC.
Version 4.1.0
In Commercial Distribution

  • 10810068810612 ()


  • Robotic surgical system application software
Monarch™ Laptop P17 Software v4.1.0
AURIS HEALTH, INC.
Version 4.1.0
In Commercial Distribution

  • 10810068810605 ()


  • Robotic surgical system application software
Knowledge Base Update for VITEK2 Software
BIOMERIEUX , INC.
9.04
In Commercial Distribution

  • 03573026626471 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD
Knowledge Base Update for VITEK2 Software
BIOMERIEUX , INC.
9.03
In Commercial Distribution

  • 03573026613914 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated
PGDx elio™ tissue complete software
PERSONAL GENOME DIAGNOSTICS INC.
B01103200
In Commercial Distribution

  • 00192721000770 ()
B01103200

  • Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
MR Applications Software for MP24 R03
GENERAL ELECTRIC COMPANY
MP24 R03
Not in Commercial Distribution

  • 00840682124591 ()


  • MRI system application software
SOFTWARE GE CLIENT WORKSTATION V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
Not in Commercial Distribution

  • 00840682123594 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
SenoIris 1 SP2.2 Software and Manuals
GE Healthcare GmbH
1
Not in Commercial Distribution

  • 00840682104395 ()


  • Diagnostic x-ray digital imaging system workstation
KIT,AVEA UPGRADE GDE,UIM & SOFTWARE
Carefusion Corporation
12283-PMN
Not in Commercial Distribution

  • 10846446064865 ()


  • Ventilator application software
SWR KIT SSPRO SOFTWARE VER 11
Carefusion Corporation
28008-001
Not in Commercial Distribution

  • 10846446032550 ()
28008-001

  • Home-use sleep apnoea recording system
SWR KIT SSPRO SOFTWARE VER 10.2
Carefusion Corporation
22312-001
Not in Commercial Distribution

  • 10846446031485 ()
22312-001

  • Home-use sleep apnoea recording system
SOFTWARE KIT VMAX ENCORE VER 21-1
Carefusion Corporation
63792
Not in Commercial Distribution

  • 10846446027693 ()
63792

  • Pulmonary function analysis system, adult
  • Pulmonary function analysis system, paediatric
SWR KIT SSPRO SOFTWARE VER 9
Carefusion Corporation
63734
Not in Commercial Distribution

  • 10846446020274 ()
63734

  • Home-use sleep apnoea recording system
Win 11 PC - Arial Software Client
Securitas Healthcare LLC
0850-222
In Commercial Distribution

  • 00840948102738 ()
0850-222

  • Fixed call button
PillCam (TM) Desktop Software v9.7 Upgrade
Given Imaging, Inc.
FGS-0803
In Commercial Distribution

  • 10884521845923 ()


  • Video capsule endoscopy system application software
PAV+ SOFTWARE, FINISHED GOOD, FACTORY INSTALL
Covidien LP
10122271
Not in Commercial Distribution

  • 10884521641013 ()


  • Ventilator application software
KARL STORZ SCB Software Upgrade "VOICE1"
Karl Storz GmbH & Co. KG
20090001-40
In Commercial Distribution

  • 04048551228517 ()


  • Operating room audiovisual data/device management system application software
BD Pyxis CIISafe (Software v9.X)
CAREFUSION 303, INC.
SW-CII-SAFE-V9
In Commercial Distribution

  • 10885403513725 ()


  • Anaesthesia cabinet
Siemens UNITY 3 SOFTWARE (USB STICK)
Ws Audiology Usa, Inc.
UNITY 3 SOFTWARE (USB STICK)
Not in Commercial Distribution

  • 04046355641976 ()
10823966

  • Audiometric/hearing aid tester
SenoIris 1 SP4.5 Software and Manuals
GE MEDICAL SYSTEMS
1
In Commercial Distribution

  • 00840682147767 ()


  • Diagnostic x-ray digital imaging system workstation
SenoIris 1 SP3.2 Software and Manuals
GE Healthcare GmbH
1
Not in Commercial Distribution

  • 00840682140614 ()


  • Diagnostic x-ray digital imaging system workstation
Planning software for total shoulder arthroplasty
PIXEE MEDICAL
FXSPS001
Not in Commercial Distribution

  • 03760297030209 ()


  • Orthopaedic/craniofacial implantation planning software
OptiBolus, Bolus Shaping Software, International (Accessory)
Liebel-Flarsheim Company LLC
844210
In Commercial Distribution

  • 10746190004813 ()


  • CT contrast medium injection system, line-powered, stationary
OptiBolus, Bolus Shaping Software, Domestic (Accessory)
Liebel-Flarsheim Company LLC
844200
In Commercial Distribution

  • 10746190004806 ()


  • CT contrast medium injection system, line-powered, stationary
Clinical Laboratory Information System application software
ASPYRA, LLC
7.3.1
In Commercial Distribution

  • B433CL0 ()
CL731

  • Clinical laboratory information system application software
360CAS KNEE NAVIGATION SYSTEM SOFTWARE v3
KICO KNEE INNOVATION COMPANY PTY LIMITED
3.1.1
In Commercial Distribution

  • B432360CAS3110 ()


  • Robotic surgical navigation system application software
360CAS KNEE NAVIGATION SYSTEM SOFTWARE v3
KICO KNEE INNOVATION COMPANY PTY LIMITED
3.1.0
In Commercial Distribution

  • B432360CAS3100 ()


  • Robotic surgical navigation system application software
Stand-alone software for GoCheck Kids Nokia.
Gobiquity, Inc.
Nokia 4.4.29
In Commercial Distribution

  • B430GCKNOK44290L ()


  • External ocular measurement camera
Lumax™ TS Pro Advanced Software
Coopersurgical, Inc.
23485
In Commercial Distribution

  • 00888937013382 ()


  • Urodynamic measurement system
TrueFit v3.7 DVD Software Package USA
Unitron Hearing Division
058-5229
In Commercial Distribution

  • 07613389221589 ()
058-5229

  • Audiometric/hearing device software
TrueFit Fitting Software v3.7 USB USA
Unitron Hearing Division
058-5228
In Commercial Distribution

  • 07613389221572 ()
058-5228

  • Audiometric/hearing device software
USB V3.6.1 Fitting Software Hansaton Scout
Hansaton Akustik GmbH
058-5227
In Commercial Distribution

  • 07613389143232 ()
058-5227

  • Audiometric/hearing device software
DVD v3.6.1 Fitting Software Hansaton Scout
Hansaton Akustik GmbH
058-5226
In Commercial Distribution

  • 07613389143225 ()
058-5226

  • Audiometric/hearing device software
ARCS ABP Analysis & Reporting Software & Dongle
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020283 ()
A10-0118-50

  • Electrocardiographic long-term ambulatory recording analyser application software
IMAGE PROCESSING SOFTWARE / FOR VITA CR
CARESTREAM HEALTH, INC.
Vita CR System
In Commercial Distribution

  • 60889971919878 ()
1919877

  • Computed radiography digital imaging scanner
CAPILLAROSCOPE HIGH RESOLUTION WITH PROFESSIONAL SOFTWARE
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-318
Not in Commercial Distribution

  • B1623181 ()
FEDMEDMICFIP5MSWC_US

  • Otoscope, direct
OB Legacy System iOS Software System
Airstrip Technologies, Inc.
1001
In Commercial Distribution

  • B15310010 ()


  • Bedside monitor remote-viewing software, physiological parameter
OB Legacy System Server Software System
Airstrip Technologies, Inc.
1000
In Commercial Distribution

  • B15310000 ()


  • Bedside monitor remote-viewing software, physiological parameter
Cardiostation Software sold with wireless devices.
UNIVERSAL MEDICAL, INC.
Cardiostation Standalone Software
In Commercial Distribution

  • B147CSS0 ()


  • Electrocardiography telemetric monitoring system
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