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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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Navios EX - 15099590683269

NAVIOS EX OFFLINE ACQ 5 USERS SOFTWARE V2.0 WIN 7
BECKMAN COULTER IRELAND INC.
OFFLINE ACQ 5 USERS SOFTWARE V2.0 WIN 7
In Commercial Distribution

  • 15099590683269 ()
B91239

  • Laboratory instrument/analyser application software IVD

LENS CONNECTED TOWER APPLICATION - 00885556778777

LENS CONNECTED TOWER APPLICATION
Smith & Nephew, Inc.
72205347
In Commercial Distribution

  • 00885556778777 ()
72205347

  • Operating room audiovisual data/device management system application software

INTEllIO LINK WEREWOLF - 00885556741641

INTELLIO LINK WEREWOLF
Smith & Nephew, Inc.
72205191
In Commercial Distribution

  • 00885556741641 ()
72205191

  • Operating room audiovisual data/device management system application software

LINK DOUBLEFLOW PUMP - 00885556741634

LINK DOUBLEFLO PUMP
Smith & Nephew, Inc.
72205190
In Commercial Distribution

  • 00885556741634 ()
72205190

  • Operating room audiovisual data/device management system application software

INTELLIO LINK Dyonics Power II - 00885556741627

INTELLIO LINK DYONICS POWER II
Smith & Nephew, Inc.
72205189
In Commercial Distribution

  • 00885556741627 ()
72205189

  • Operating room audiovisual data/device management system application software

INTELLIO Tablet - 00885556866108

INTELLIO TABLET COUNTRY KIT EN US
Smith & Nephew, Inc.
72205719
In Commercial Distribution

  • 00885556866108 ()
72205719

  • Operating room audiovisual data/device management system application software

INTELLIO Tablet - 00885556813683

INTELLIO TABLET
Smith & Nephew, Inc.
72205455
In Commercial Distribution

  • 00885556813683 ()
72205455

  • Operating room audiovisual data/device management system application software

DIGITAL DIAGNOSTICS SYSTEM - 15420045517585

Computer to operate the Genius™ Review Station.
Hologic, Inc.
ASSEMBLY, REVIEW STATION COMPUTER
In Commercial Distribution

  • 15420045517585 ()
ASY-17964

  • Laboratory instrument/analyser application software IVD

DIGITAL DIAGNOSTICS SYSTEM - 15420045517097

Computer to operate the Genius™ Review Station.
Hologic, Inc.
ASSEMBLY, REVIEW STATION COMPUTER
In Commercial Distribution

  • 15420045517097 ()
ASY-14304

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045515062

Computer to operate the ThinPrep® Review Scope Manual+.
Hologic, Inc.
ThinPrep Imaging System Computer
In Commercial Distribution

  • 15420045515062 ()
CMP-01836

  • Laboratory instrument/analyser application software IVD

DIGITAL DIAGNOSTICS SYSTEM - 15420045514201

Medical grade Genius™ Review Station monitor for use with the Genius™ Digital Diagnostics System.
Hologic, Inc.
DISPLAY, 27IN, 8MP
In Commercial Distribution

  • 15420045514201 ()
CMP-01669

  • Laboratory instrument/analyser application software IVD

Caption - 00198953030233

Caption AI on Vscan
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
AI
In Commercial Distribution

  • 00198953030233 ()


  • Ultrasound imaging system application software

Alinity m - 00884999051300

Alinity m EBV Application Specification File
ABBOTT MOLECULAR INC.
09N43-05B
In Commercial Distribution

09N43-05B

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999051096

Alinity m STI Application Specification File
ABBOTT MOLECULAR INC.
09N17-03B
In Commercial Distribution

09N17-03B

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999051065

Alinity m CMV Application Specification File
ABBOTT MOLECULAR INC.
09N46-05B
In Commercial Distribution

09N46-05B

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999050945

Alinity m BKV Application Specification File
ABBOTT MOLECULAR INC.
09N85-05A
In Commercial Distribution

  • 00884999050945 ()
09N85-05A

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999050860

Alinity m HCV Application Specification File
ABBOTT MOLECULAR INC.
08N50-03B
In Commercial Distribution

  • 00884999050860 ()
08N50-03B

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999050853

Alinity m HIV-1 Application Specification File
ABBOTT MOLECULAR INC.
08N45-03C
In Commercial Distribution

  • 00884999050853 ()
08N45-03C

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999050808

Alinity m HBV Application Specification File
ABBOTT MOLECULAR INC.
08N47-03B
In Commercial Distribution

  • 00884999050808 ()
08N47-03B

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999050778

Alinity m MPXV Application Specification File
ABBOTT MOLECULAR INC.
09R06-05A
In Commercial Distribution

  • 00884999050778 ()
09R06-05A

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999050570

Alinity m HSV 1 & 2 / VZV Application Specification File
ABBOTT MOLECULAR INC.
09N61-03A
In Commercial Distribution

  • 00884999050570 ()
09N61-03A

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999050464

Alinity m Resp-4-Plex Application Specification File
ABBOTT MOLECULAR INC.
09N79-05E
In Commercial Distribution

  • 00884999050464 ()
09N79-05E

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999050457

Alinity m SARS-CoV-2 Application Specification File
ABBOTT MOLECULAR INC.
09N78-03F
In Commercial Distribution

  • 00884999050457 ()
09N78-03F

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999050402

Alinity m HIV-1 Application Specification File
ABBOTT MOLECULAR INC.
08N45-03B
In Commercial Distribution

  • 00884999050402 ()
08N45-03B

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999050242

Alinity m Resp-4-Plex Application Specification File
ABBOTT MOLECULAR INC.
09N79-05D
In Commercial Distribution

  • 00884999050242 ()
09N79-05D

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999050211

Alinity m SARS-CoV-2 Application Specification
ABBOTT MOLECULAR INC.
09N78-03E
In Commercial Distribution

  • 00884999050211 ()
09N78-03E

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999050136

Alinity m SARS COV-2 Application Specification File
ABBOTT MOLECULAR INC.
09N78-03D
In Commercial Distribution

  • 00884999050136 ()
09N78-03D

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999050020

No Description
ABBOTT MOLECULAR INC.
09N79-05C
In Commercial Distribution

  • 00884999050020 ()
09N79-05C

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999049956

Alinity m CMV Application Specification File
ABBOTT MOLECULAR INC.
09N46-05A
In Commercial Distribution

  • 00884999049956 ()
09N46-05A

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999049697

Alinity m EBV ApplicationSpecification File
ABBOTT MOLECULAR INC.
09N43-05A
In Commercial Distribution

  • 00884999049697 ()
09N43-05A

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999049413

Alinity m Resp-4-Plex Application Specification File
ABBOTT MOLECULAR INC.
09N79-05A
In Commercial Distribution

  • 00884999049413 ()
09N79-05A

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999049383

Alinity m Resp-4-Plex Application Specification File
ABBOTT MOLECULAR INC.
09N79-03A
In Commercial Distribution

  • 00884999049383 ()
09N79-03A

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999049185

Alinity m SARS-CoV-2 Application Specification File
ABBOTT MOLECULAR INC.
09N78-03A
In Commercial Distribution

  • 00884999049185 ()
09N78-03A

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999049055

Abbott RealTime SARS-CoV-2 Application CD-ROM
ABBOTT MOLECULAR INC.
09N77-010
In Commercial Distribution

  • 00884999049055 ()
09N77-010

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999048676

Alinity m HR HPV Application Specification File
ABBOTT MOLECULAR INC.
09N15-03A
In Commercial Distribution

  • 00884999048676 ()
09N15-03A

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999048669

Alinity m STI Application Specification File
ABBOTT MOLECULAR INC.
09N17-03A
In Commercial Distribution

  • 00884999048669 ()
09N17-03A

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999048652

Alinity m HCV Application Specification File
ABBOTT MOLECULAR INC.
08N50-03A
In Commercial Distribution

  • 00884999048652 ()
08N50-03A

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999048645

Alinity m HBV Application Specification File
ABBOTT MOLECULAR INC.
08N47-03A
In Commercial Distribution

  • 00884999048645 ()
08N47-03A

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999048638

Alinity m HIV-1 Application Specification File
ABBOTT MOLECULAR INC.
08N45-03A
In Commercial Distribution

  • 00884999048638 ()
08N45-03A

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999048065

Abbott RealTime HIV-1 m2000 System Combined Application CD-ROM
ABBOTT MOLECULAR INC.
06L83-008
In Commercial Distribution

  • 00884999048065 ()
06L83-008

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999047792

Abbott RealTime IDH1m2000rt Application CD-ROM
ABBOTT MOLECULAR INC.
08N90-006
In Commercial Distribution

  • 00884999047792 ()
08N90-006

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999047297

Abbott RealTime CMV m2000 System Combined Application CD-ROM
ABBOTT MOLECULAR INC.
09N21-002
In Commercial Distribution

  • 00884999047297 ()
09N21-002

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999047068

Abbott RealTime ZIKA Application CD-ROM
ABBOTT MOLECULAR INC.
09N27-002
In Commercial Distribution

  • 00884999047068 ()
09N27-002

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999047037

Abbott RealTime IDH2 m2000rt Application CD-ROM
ABBOTT MOLECULAR INC.
08N82-001
In Commercial Distribution

  • 00884999047037 ()
08N82-001

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999042704

Abbott RealTime HIV-1 m2000 System Combined Application CD-ROM
ABBOTT MOLECULAR INC.
06L83-007
Not in Commercial Distribution

  • 00884999042704 ()
06L83-007

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999042681

Abbott RealTime HCV m2000 System Combined Application CD-ROM
ABBOTT MOLECULAR INC.
04N45-004
In Commercial Distribution

  • 00884999042681 ()
04N45-004

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999042667

Abbott RealTime HBV m2000 System Combined Application CD-ROM
ABBOTT MOLECULAR INC.
02N43-004
In Commercial Distribution

  • 00884999042667 ()
02N43-004

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999042513

Abbott RealTime HCV Genotype II m2000 System Combined Application CD-ROM
ABBOTT MOLECULAR INC.
08L21-002
In Commercial Distribution

  • 00884999042513 ()
08L21-002

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999037762

Abbott RealTime HBV m2000 System Combined Application CD-ROM, Version 3.0
ABBOTT MOLECULAR INC.
2N43-03
In Commercial Distribution

  • 00884999037762 ()
2N43-03

  • Laboratory instrument/analyser application software IVD

RealTime - 00884999037656

Abbott RealTime HCV m2000 System Combined Application CD-ROM, Version 3.0
ABBOTT MOLECULAR INC.
4N45-03
In Commercial Distribution

  • 00884999037656 ()
4N45-03

  • Laboratory instrument/analyser application software IVD
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