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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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AngioDynamics - H7877001049180

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

seca analytics 125 - 04012030022910

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

seca analytics 125 - 04012030020794

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

seca analytics 125 - 04012030021678

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

seca analytics 125 - 04012030020503

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

FONA CDR DICOM - D764B10351060

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

VIDAS® PC SOFTWARE V4.9 - 03573026619527

VIDAS PC V4.9 W10 Software version for clinic
BIOMERIEUX SA
4.9
In Commercial Distribution

  • 03573026619527 ()


  • Fluorescent immunoassay analyser IVD, laboratory

4Klearity - 00817613021021

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 - 07640176970535

NAVIPLAN, CT Planning Software for Total Hip Replacement
Naviswiss AG
NS053
In Commercial Distribution

  • 07640176970535 ()


  • Orthopaedic/craniofacial implantation planning software

GoCheck Kids - B430GCKNOK44360

GoCheck Kids stand-alone software for the Nokia device.
Gobiquity, Inc.
Nokia 4.4.36
In Commercial Distribution

  • B430GCKNOK44360 ()


  • External ocular measurement camera

Vasomedical-Biox™ ARCS ABP Analysis & Reporting S/W & Dongle w/Bluetooth - 00817980020290

ARCS ABP Analysis & Reporting Software & Dongle w/Bluetooth
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020290 ()
A10-0118-60

  • Electrocardiographic long-term ambulatory recording analyser application software

Vasomedical-Biox™ CB Series Analysis & Reporting Software - 3 CH ECG - 00817980020146

CB Series Analysis & Reporting Software - 3 CH ECG
VASOMEDICAL, INC.
CB Series S/W
In Commercial Distribution

  • 00817980020146 ()
A10-0032

  • Electrocardiographic long-term ambulatory recording analyser application software

Lumax - 60888937013452

Lumax™ TS Pro • EMG Software Upgrade Kit
Coopersurgical, Inc.
53366
In Commercial Distribution

  • 60888937013452 ()


  • Urodynamic measurement system

Aurora Xi - 00810020442199

Aurora Xi Plasmapheresis System with Software Version 2.0
Fresenius Kabi AG
Software Version 2.0
In Commercial Distribution

  • 00810020442199 ()


  • Apheresis system

AMICUS Separator Life Extension Software - 00810020441192

Software version for AMICUS Separator Life Extension Device
Fresenius Kabi AG
6.1.122.0
In Commercial Distribution

  • 00810020441192 ()


  • Apheresis system

AMICUS Separator Life Extension Software - 00810020440607

Software version for AMICUS Separator Life Extension Device
Fresenius Kabi AG
6.1.113.0
In Commercial Distribution

  • 00810020440607 ()


  • Apheresis system

Aurora Xi - 00810020440560

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

  • 00810020440560 ()


  • Apheresis system

AMICUS Separator Life Extension Software - 00810020440171

Software version for AMICUS Separator life extension device
Fresenius Kabi AG
6.0
In Commercial Distribution

  • 00810020440171 ()


  • Apheresis system

Stellaris - 00757770520251

Stellaris PC with Laser with Version 4+ Software
Bausch & Lomb Incorporated
BL14304
In Commercial Distribution

  • 00757770520251 ()
BL14304

  • Phacoemulsification/vitrectomy system

Stellaris - 00757770520190

Stellaris Vision Enhancement System with Version 4+ Software
Bausch & Lomb Incorporated
BL11114
In Commercial Distribution

  • 00757770520190 ()
BL11114

  • Phacoemulsification/vitrectomy system

Stellaris - 00757770519996

Stellairs PC Combined System with Version 4+ Software
Bausch & Lomb Incorporated
BL14334
In Commercial Distribution

  • 00757770519996 ()
BL14334

  • Phacoemulsification/vitrectomy system

Stellaris - 00757770519897

Stellaris PC with Laser with Version 4+ Software
Bausch & Lomb Incorporated
BL14304
Not in Commercial Distribution

  • 00757770519897 ()
BL14304

  • Phacoemulsification/vitrectomy system

VP2000 - 00884999048478

VP 2000 System Software v2.1 with Protocols USB
ABBOTT MOLECULAR INC.
02J11-057
In Commercial Distribution

  • 00884999048478 ()
02J11-057

  • Tissue processor IVD, automated/semi-automated

Norav 1200 Series PC-ECG - 07290110255008

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Driver for P-MP200 Thermal Printer The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW P-MP200
In Commercial Distribution

  • 07290110255008 ()
HASP-SW-K-P1-01

  • Thermal printer

Norav 1200 Series PC-ECG - 07290110252670

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - NER = Event Recording Analysis Tool The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NER
In Commercial Distribution

  • 07290110252670 ()
HASP-SW-K-NER1-01

  • Electrocardiographic long-term ambulatory recording analyser

Norav 1200 Series PC-ECG - 07290110252649

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - L1 = Late Potential Analysis Module The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW L1
In Commercial Distribution

  • 07290110252649 ()
HASP-SW-K-L1-01

  • Cardiovascular risk evaluation interpretive software

Norav 1200 Series PC-ECG - 07290110252618

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - H1 = Heart Rate Variability Analysis The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW H1
In Commercial Distribution

  • 07290110252618 ()
HASP-SW-K-H1-01

  • Cardiovascular risk evaluation interpretive software

NA - 00724995163723

The IDSS-SLC Version 8 OR Integration software module allows the remote control of surgical lights during a surgical procedure and the software provides support for routing higher resolution 4K video when used with supporting 4K routing hardware installed in the BDV IDSS integration system.
BLACK DIAMOND VIDEO, INC.
IDSS-SLC Version 8
Not in Commercial Distribution

  • 00724995163723 ()
XQSLC1

  • Operating room audiovisual data/device management system application software

NA - 00724995153083

The IDSS-SLC Version 7 OR Integration software module allows the remote control of surgical lights during a surgical procedure.
BLACK DIAMOND VIDEO, INC.
IDSS-SLC
Not in Commercial Distribution

  • 00724995153083 ()
XQSLC1

  • Operating room audiovisual data/device management system application software

NA - 00724995152031

OR Integration software module Version 6 that allows the remote control of surgical lights during a surgical procedure.
BLACK DIAMOND VIDEO, INC.
IDSS-SLC
Not in Commercial Distribution

  • 00724995152031 ()


  • Operating room audiovisual data/device management system application software
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