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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8ch Anorectal SUM 0,0.5
Covidien LP
9012P1412
Not in Commercial Distribution

  • 05704736001311 ()
  • 10884521742710 ()
9012P1412

  • Manometric gastrointestinal motility analysis system
4 ch Anorectal Cat. Sil. w/Bal,
Covidien LP
9012P1392
Not in Commercial Distribution

  • 05704736001304 ()
  • 10884521742703 ()
9012P1392

  • Manometric gastrointestinal motility analysis system
Single use Catheter 4 ch w/o central lum
Covidien LP
9012P1362
Not in Commercial Distribution

  • 05704736001298 ()
  • 10884521742819 ()
9012P1362

  • Manometric gastrointestinal motility analysis system
4ch 7.5mm sp Esophageal
Covidien LP
9012P1352
Not in Commercial Distribution

  • 05704736001281 ()
  • 10884521742802 ()
9012P1352

  • Manometric gastrointestinal motility analysis system
8ch Anorectal SinUse Man,
Covidien LP
9012P1322
Not in Commercial Distribution

  • 05704736001274 ()
  • 10884521742796 ()
9012P1322

  • Manometric gastrointestinal motility analysis system
8ch Vector Vol. SinUse Man
Covidien LP
9012P1312
Not in Commercial Distribution

  • 05704736001267 ()
  • 10884521742789 ()
9012P1312

  • Manometric gastrointestinal motility analysis system
4ch Anorectal SinUse Man.cath,0,1,2,3-ba
Covidien LP
9012P1302
Not in Commercial Distribution

  • 05704736001250 ()
  • 10884521742772 ()
9012P1302

  • Manometric gastrointestinal motility analysis system
8ch Esophageal Sinuse Ma,
Covidien LP
9012P1212
Not in Commercial Distribution

  • 05704736001243 ()
  • 10884521742758 ()
9012P1212

  • Manometric gastrointestinal motility analysis system
8ch Esophageal Sinuse Ma,
Covidien LP
9012P1222
Not in Commercial Distribution

  • 05704736001236 ()
  • 10884521742765 ()


  • Manometric gastrointestinal motility analysis system
Esophageal SinUse Man. Cath.,0,5,10,15 c
Covidien LP
9012P1202
Not in Commercial Distribution

  • 05704736001229 ()
  • 15704736001226 ()


  • Manometric gastrointestinal motility analysis system
2 Channel Compressed Air SOM Pump
H & A Mui Enterprises Inc
PIP-5-2SS
Not in Commercial Distribution

  • 00678467004161 ()


  • Manometric gastrointestinal motility analysis system
24 Channel Portable Compressed Air Manometric Pump
H & A Mui Enterprises Inc
P3-PIP-6-24SS
In Commercial Distribution

  • 00678467003430 ()


  • Manometric gastrointestinal motility analysis system
No Description
Luminance Medical Ventures Incorporated
TN1927D
In Commercial Distribution

  • 00860002593036 ()


  • Red/blue light phototherapy unit
Critical Alert CommonPath Enterprise (CommonPath) is a software application installed on a Windows server environment capable of acquiring alarms, events, and parameters from clinical systems and intelligently forwarding this information as notifications to designated display devices provided by third-party mobile device companies.
Critical Alert
In Commercial Distribution

  • 00860006582005 ()


  • Alarm application software
Messenger 6.1.1 Software Release
SPOK INC.
6.1.0
In Commercial Distribution

  • 00860011811961 ()


  • Alarm application software
Messenger 5.18.4 Software Release
SPOK INC.
5.18.4
In Commercial Distribution

  • 00860011811954 ()


  • Alarm application software
Messenger 5.17.17 Software Release
SPOK INC.
5.17.17
In Commercial Distribution

  • 00860011811947 ()


  • Alarm application software
Messenger 5.18.3 Software Release
SPOK INC.
5.18.3
In Commercial Distribution

  • 00860011811930 ()


  • Alarm application software
Messenger 6.1.0 Software Release
SPOK INC.
6.1.0
In Commercial Distribution

  • 00860011811923 ()


  • Alarm application software
Messenger 5.18.2 Software Release
SPOK INC.
5.18.2
In Commercial Distribution

  • 00860011811916 ()


  • Alarm application software
Messenger 5.17.16 Software Release
SPOK INC.
5.17.16
In Commercial Distribution

  • 00860011811909 ()


  • Alarm application software
No Description
STRYKER CORPORATION
EMDAN 2.3.1
In Commercial Distribution

  • 00860002177786 ()
910-01957

  • Alarm application software
No Description
STRYKER CORPORATION
910-01947
In Commercial Distribution

  • 00860002177779 ()
910-01947

  • Alarm application software
No Description
STRYKER CORPORATION
EMDAN 2.5.0
In Commercial Distribution

  • 00860002177762 ()
910-01959

  • Alarm application software
No Description
STRYKER CORPORATION
EMDAN 2.4.0
In Commercial Distribution

  • 00860002177755 ()
910-01958

  • Alarm application software
No Description
STRYKER CORPORATION
EMDAN 2.3.0
In Commercial Distribution

  • 00860002177748 ()
910-01956

  • Alarm application software
No Description
STRYKER CORPORATION
EMDAN 2.1.1
In Commercial Distribution

  • 00860002177731 ()
910-01954

  • Alarm application software
No Description
STRYKER CORPORATION
EMDAN 1.10.0
In Commercial Distribution

  • 00860002177724 ()
910-01952

  • Alarm application software
No Description
STRYKER CORPORATION
EMDAN 2.2.0
In Commercial Distribution

  • 00860002177717 ()
910-01955

  • Alarm application software
No Description
STRYKER CORPORATION
EMDAN 2.1.0
In Commercial Distribution

  • 00860002177700 ()
910-01953

  • Alarm application software
3 Channel Compressed Air SOM Pump
H & A Mui Enterprises Inc
PIP-5-3SS
Not in Commercial Distribution

  • 00678467000071 ()


  • Manometric gastrointestinal motility analysis system
12 Channel Compressed Air Manometric Pump
H & A Mui Enterprises Inc
PIP-4-12SS
Not in Commercial Distribution

  • 00678467000040 ()


  • Manometric gastrointestinal motility analysis system
8 Channel Compressed Air Manometric Pump
H & A Mui Enterprises Inc
PIP-4-8SS
Not in Commercial Distribution

  • 00678467000033 ()


  • Manometric gastrointestinal motility analysis system
6 Channel Compressed Air Manometric Pump
H & A Mui Enterprises Inc
PIP-4-6SS
Not in Commercial Distribution

  • 00678467000026 ()


  • Manometric gastrointestinal motility analysis system
4 Channel Compressed Air Manometric Pump
H & A Mui Enterprises Inc
PIP-4-4SS
Not in Commercial Distribution

  • 00678467000019 ()


  • Manometric gastrointestinal motility analysis system
The HeartFlow Analysis is AI-based medical device software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries in the risk stratification and evaluation of coronary artery disease. The software displays coronary anatomy and functional information using graphics and text, including computed and derived quantities of percent stenosis, plaque volumes, blood flow, pressure and velocity, to aid the clinician in the assessment and treatment planning of coronary artery disease. The HeartFlow Analysis is performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations.
Heartflow, Inc.
FFRct version 3
In Commercial Distribution

  • 00853341006060 ()


  • Vascular modelling software
The HeartFlow Analysis is coronary physiologic simulation software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries. The software displays the anatomy combined with functional information using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid the clinician in the assessment and treatment planning of coronary artery disease. The HeartFlow Analysis is performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations.
Heartflow, Inc.
FFRct version 3
In Commercial Distribution

  • 00853341006053 ()


  • Vascular modelling software
The HeartFlow Analysis is coronary physiologic simulation software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries. The software displays the anatomy combined with functional information using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid the clinician in the assessment and treatment planning of coronary artery disease. The HeartFlow Analysis is performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations.
Heartflow, Inc.
FFRct version 2
In Commercial Distribution

  • 00853341006039 ()


  • Vascular modelling software
HeartFlow FFRct is coronary physiologic simulation software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries. The software displays the anatomy combined with functional information using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid the clinician in the assessment of coronary artery disease. FFRct is independent of imaging equipment, imaging protocols and equipment vendors; the clinical validation report includes identification of vendors and equipment used in the clinical validation of the product. This data is summarized in the product labeling, and can be found in the Clinical User Instructions for Use. HeartFlow FFRct analyses are performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations.
Heartflow, Inc.
v2.18
In Commercial Distribution

  • 00853341006022 ()


  • Vascular modelling software
HeartFlow FFRct is an image analysis software developed for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries. The software displays the anatomy combined with functional information using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid the clinician in the assessment of coronary artery disease. HeartFlow FFRct is independent of imaging equipment, imaging protocols and equipment vendors. HeartFlow analyses are performed on previously physician-acquired image data and are unrelated to acquisition equipment and workstations.
Heartflow, Inc.
v2.1
In Commercial Distribution

  • 00853341006015 ()


  • Vascular modelling software
HeartFlow FFRct is an image analysis software developed for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries. The software displays the anatomy combined with functional information using graphics and text, including computed and derived quantities of blood flow, pressure and velocity, to aid the clinician in the assessment of coronary artery disease. HeartFlow FFRct is independent of imaging equipment, imaging protocols and equipment vendors. HeartFlow analyses are performed on previously physician-acquired image data and are unrelated to acquisition equipment and workstations.
Heartflow, Inc.
v2.1
In Commercial Distribution

  • 00853341006008 ()


  • Vascular modelling software
No Description
Cerner Corporation
CareAwareEventManagement6
In Commercial Distribution

  • 00853023006135 ()


  • Alarm application software
No Description
Cerner Corporation
CareAwareEventManagement5
In Commercial Distribution

  • 00853023006111 ()


  • Alarm application software
SEER 1000 PC APPLICATION
Ge Medical Systems Information Technologies, Inc.
1000 PC Application
In Commercial Distribution

  • 00840682116886 ()


  • Electrocardiographic ambulatory recorder
SEER 1000 IOS APPLICATION
Ge Medical Systems Information Technologies, Inc.
1000 IOS Application
In Commercial Distribution

  • 00840682116879 ()


  • Electrocardiographic ambulatory recorder
SenoIris 1 SP2.2 Software and Manuals
GE Healthcare GmbH
1
Not in Commercial Distribution

  • 00840682104395 ()


  • Diagnostic x-ray digital imaging system workstation
Endoflip system 1.0 refurbished
Covidien LP
RFG-EF100
In Commercial Distribution

  • 10884521808096 ()


  • Manometric gastrointestinal motility analysis system
Endolumenal Functional Lumen Imaging Probe
Covidien LP
EF-325N
In Commercial Distribution

  • 20884521809427 ()
  • 10884521809420 ()
  • 30884521809424 ()


  • Manometric gastrointestinal motility analysis system
Endolumenal Functional Lumen Imaging Probe
Covidien LP
EF-322N
In Commercial Distribution

  • 20884521809410 ()
  • 10884521809413 ()
  • 30884521809417 ()


  • Manometric gastrointestinal motility analysis system
LK-103 ENDOFLIP LOCALIZATION KIT US
Covidien LP
LK-103
In Commercial Distribution

  • 10884521809376 ()


  • Manometric gastrointestinal motility analysis system
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