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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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The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution

  • 00858012005854 ()
DSC017-04-US

  • Basic diagnostic x-ray system application software
The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution

  • 00858012005601 ()
DSC017-01-US

  • Basic diagnostic x-ray system application software
AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/THC50/(OX/pH/SG)/(GL/NI/CR)
NEXSCREEN, LLC
NCard-12+4
In Commercial Distribution

  • 00858984006330 ()
NCard-12+4

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/COC150/OPI2000/PCP25/THC50/(OX/pH/SG)
NEXSCREEN, LLC
ND-60505N-3A
In Commercial Distribution

  • 00858984006248 ()
ND-60505N-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/COC150/MET500/OPI2000/THC50/(OX/pH/SG)
NEXSCREEN, LLC
ND-60500N-3A
In Commercial Distribution

  • 00858984006224 ()
ND-60500N-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
NINEPOINT MEDICAL, INC.
94301-MI-UPG
In Commercial Distribution

  • 00859591006263 ()


  • Endoscopic optical coherence tomography system
No Description
NINEPOINT MEDICAL, INC.
94301-MI-R
In Commercial Distribution

  • 00859591006256 ()
94301-MI-R

  • Endoscopic optical coherence tomography system
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-054849-00
In Commercial Distribution

  • 06936415902698 ()


  • General-purpose multi-parameter bedside monitor
7' gas sampling line w/swivel elbow, reflective luer
WESTMED, INC.
0938
Not in Commercial Distribution

  • 10709078005852 ()
  • 00709078005855 ()


  • Nasal oxygen cannula, carbon-dioxide-sampling
No Description
Serres Oy
570187-5
In Commercial Distribution

  • 06418685061980 ()
  • 06418685061973 ()
  • 06418685062598 ()


  • Suction system canister liner
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