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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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Alinity c Calcium U Assay File
Abbott GmbH
07P573A
In Commercial Distribution

  • 00380740141837 ()
07P573A

  • Laboratory instrument/analyser application software IVD
Alinity c Calcium Assay File
Abbott GmbH
07P571A
In Commercial Distribution

  • 00380740141820 ()
07P571A

  • Laboratory instrument/analyser application software IVD
Alinity c UreaU Assay File
Abbott GmbH
08P163A
In Commercial Distribution

  • 00380740141813 ()
08P163A

  • Laboratory instrument/analyser application software IVD
Alinity c Urea Assay File
Abbott GmbH
08P161A
In Commercial Distribution

  • 00380740141806 ()
08P161A

  • Laboratory instrument/analyser application software IVD
Alinity c ALT Assay File
Abbott GmbH
07P981A
In Commercial Distribution

  • 00380740141790 ()
07P981A

  • Laboratory instrument/analyser application software IVD
Alinity c CO2 Assay File
Abbott GmbH
07P721A
In Commercial Distribution

  • 00380740141783 ()
07P721A

  • Laboratory instrument/analyser application software IVD
Alinity c GGT-Conv Assay File
Abbott GmbH
07P733A
In Commercial Distribution

  • 00380740141776 ()
07P733A

  • Laboratory instrument/analyser application software IVD
Alinity c GGT Assay File
Abbott GmbH
07P731A
In Commercial Distribution

  • 00380740141769 ()
07P731A

  • Laboratory instrument/analyser application software IVD
Alinity c PhosU Assay File
Abbott GmbH
08P403A
In Commercial Distribution

  • 00380740141752 ()
08P403A

  • Laboratory instrument/analyser application software IVD
Alinity c Phosphorus Assay File
Abbott GmbH
08P401A
In Commercial Distribution

  • 00380740141745 ()
08P401A

  • Laboratory instrument/analyser application software IVD
Alinity c Trig Assay File
Abbott GmbH
07P771A
In Commercial Distribution

  • 00380740141738 ()
07P771A

  • Laboratory instrument/analyser application software IVD
Alinity c Ultra HDL Assay File
Abbott GmbH
07P751A
In Commercial Distribution

  • 00380740141721 ()
07P751A

  • Laboratory instrument/analyser application software IVD
Alinity c UricU Assay File
Abbott GmbH
08P563A
In Commercial Distribution

  • 00380740141714 ()
08P563A

  • Laboratory instrument/analyser application software IVD
Alinity c Uric Acid Assay File
Abbott GmbH
08P561A
In Commercial Distribution

  • 00380740141707 ()
08P561A

  • Laboratory instrument/analyser application software IVD
Alinity c CK Assay File
Abbott GmbH
08P421A
In Commercial Distribution

  • 00380740141684 ()
08P421A

  • Laboratory instrument/analyser application software IVD
Alinity c LDH Assay File
Abbott GmbH
07P741A
In Commercial Distribution

  • 00380740141677 ()
07P741A

  • Laboratory instrument/analyser application software IVD
Alinity c Chol Assay File
Abbott GmbH
07P761A
In Commercial Distribution

  • 00380740141660 ()
07P761A

  • Laboratory instrument/analyser application software IVD
Alinity c AlkP Assay File
Abbott GmbH
08P201A
In Commercial Distribution

  • 00380740141653 ()
08P201A

  • Laboratory instrument/analyser application software IVD
Alinity c Cl-CU Assay File
Abbott GmbH
07P536A
In Commercial Distribution

  • 00380740141646 ()
07P536A

  • Laboratory instrument/analyser application software IVD
Alinity c Cl-C Assay File
Abbott GmbH
07P535A
In Commercial Distribution

  • 00380740141639 ()
07P535A

  • Laboratory instrument/analyser application software IVD
Alinity c K-CU Assay File
Abbott GmbH
07P534A
In Commercial Distribution

  • 00380740141622 ()
07P534A

  • Laboratory instrument/analyser application software IVD
Alinity c K-C Assay File
Abbott GmbH
07P533A
In Commercial Distribution

  • 00380740141615 ()
07P533A

  • Laboratory instrument/analyser application software IVD
Alinity c Na-CU Assay File
Abbott GmbH
07P532A
In Commercial Distribution

  • 00380740141608 ()
07P532A

  • Laboratory instrument/analyser application software IVD
Alinity c Na-C Assay File
Abbott GmbH
07P531A
In Commercial Distribution

  • 00380740141592 ()
07P531A

  • Laboratory instrument/analyser application software IVD
Alinity c AST Assay File
Abbott GmbH
08P171A
In Commercial Distribution

  • 00380740141585 ()
08P171A

  • Laboratory instrument/analyser application software IVD
Alinity c Total Prot Assay File
Abbott GmbH
07P521A
In Commercial Distribution

  • 00380740141578 ()
07P521A

  • Laboratory instrument/analyser application software IVD
ARCHITECT i1000SR System e-Assay CDROM
ABBOTT LABORATORIES
4P57-19
Not in Commercial Distribution

  • 00380740139537 ()
04P5719

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System e-Assay CD-ROM
ABBOTT LABORATORIES
4P55-16
Not in Commercial Distribution

  • 00380740139520 ()
04P5516

  • Laboratory instrument/analyser application software IVD
Alinity i TSH Assay File
Abbott GmbH
07P481A
In Commercial Distribution

  • 00380740138899 ()
07P481A

  • Laboratory instrument/analyser application software IVD
ARCHITECT i1000SR System e-Assay CD-ROM
ABBOTT LABORATORIES
4P57-18
Not in Commercial Distribution

  • 00380740138615 ()
04P5718

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System e-Assay CD-ROM
ABBOTT LABORATORIES
4P55-15
Not in Commercial Distribution

  • 00380740138608 ()
04P5515

  • Laboratory instrument/analyser application software IVD
ARCHITECT cSystems Assay Disk SI Units version 22.0
ABBOTT LABORATORIES
04J6225
In Commercial Distribution

  • 00380740007584 ()
04J6225

  • Laboratory instrument/analyser application software IVD
Diagnostic device to perform non-contact measurements of the corneal tomography, anterior chamber parameter, pupil diameter, axial length, and optical aberrations of the patient’s eye.
Alcon Laboratories, Inc.
1023
In Commercial Distribution

  • 00380659984372 ()
8065998437

  • Eye anterior segment analyser
No Description
Heidelberg Engineering GmbH
Software V.1.2.4 US
In Commercial Distribution

  • 04059237000945 ()


  • Eye anterior segment analyser
No Description
Heidelberg Engineering GmbH
88036
In Commercial Distribution

  • 04059237000938 ()


  • Eye anterior segment analyser
No Description
Heidelberg Engineering GmbH
88036
In Commercial Distribution

  • 04059237000877 ()


  • Eye anterior segment analyser
No Description
Heidelberg Engineering GmbH
Software with HEYEX 2 V1.2.3
In Commercial Distribution

  • 04059237000754 ()


  • Eye anterior segment analyser
No Description
Heidelberg Engineering GmbH
N/A
In Commercial Distribution

  • 04059237000747 ()
  • 04059237000860 ()
18829

  • Eye anterior segment analyser
No Description
Heidelberg Engineering GmbH
88036
In Commercial Distribution

  • 04059237000617 ()


  • Eye anterior segment analyser
DRIVER HF UNIT KLS MARTIN
Richard Wolf GmbH
5592606
Not in Commercial Distribution

  • 04055207057537 ()
5592606

  • Operating room audiovisual data/device management system application software
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