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

  • 00757770519996 ()
BL14334

  • Phacoemulsification/vitrectomy system
Stellaris PC with Laser with Version 4+ Software
Bausch & Lomb Incorporated
BL14304
Not in Commercial Distribution

  • 00757770519897 ()
BL14304

  • Phacoemulsification/vitrectomy system
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 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 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 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 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
Torrent Suite Dx SW, Installer V5.14.2
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A40001728
In Commercial Distribution

  • 10190302019958 ()


  • Laboratory instrument/analyser application software IVD
No Description
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A40002323
In Commercial Distribution

  • 10190302019859 ()


  • Laboratory instrument/analyser application software IVD
No Description
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A59789
In Commercial Distribution

  • 10190302019514 ()


  • Laboratory instrument/analyser application software IVD
No Description
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A58343
In Commercial Distribution

  • 10190302019408 ()


  • Laboratory instrument/analyser application software IVD
No Description
LIFE TECHNOLOGIES CORPORATION
A54068
In Commercial Distribution

  • 10190302017978 ()


  • Laboratory instrument/analyser application software IVD
No Description
LIFE TECHNOLOGIES CORPORATION
A54067, V1.2.0
In Commercial Distribution

  • 10190302017961 ()


  • Laboratory instrument/analyser application software IVD
SW Installer
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A52422
In Commercial Distribution

  • 10190302017848 ()


  • Laboratory instrument/analyser application software IVD
ODXTT UG & ADF V10.0 USB - USA
LIFE TECHNOLOGIES CORPORATION
A51694
In Commercial Distribution

  • 10190302017756 ()


  • Human genomic analysis interpretive software
KIT,USB DIOMNI SW V2.0.0
LIFE TECHNOLOGIES CORPORATION
A53120
In Commercial Distribution

  • 10190302017701 ()


  • Laboratory instrument/analyser application software IVD
No Description
LIFE TECHNOLOGIES CORPORATION
A52570, V1.1.0
In Commercial Distribution

  • 10190302017312 ()


  • Laboratory instrument/analyser application software IVD
KIT,TS DX SW,V5.12.5 INSTALLER
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A46166
In Commercial Distribution

  • 10190302016810 ()


  • Laboratory instrument/analyser application software IVD
ODXTT UG & ADF V3.6 USB-US
LIFE TECHNOLOGIES CORPORATION
A49678
In Commercial Distribution

  • 10190302015646 ()


  • Human genomic analysis interpretive software
KIT,QS DX SW V1.0.4
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A48389
In Commercial Distribution

  • 10190302015615 ()


  • Laboratory instrument/analyser application software IVD
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