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 A-PULSE CASP® pulse wave analysis system consists of the BPro® radial pulse wave acquisition device, a blood pressure (BP) calibrator and the A-PULSE CASP® pulse wave application software. The BPro® device is used to capture the pulse wave from the radial artery, and the BP calibrator is used to calibrate the pulse wave. Once the pulse wave is calibrated, the software is used to derive the central aortic systolic pressure, radial augmentation index (rAI) and a range of other pulse wave indices. The software allows the pulse wave, blood pressure readings and pulse rate readings to be displayed, stored and printed. The MC3100™ oscillometric blood pressure monitor, or an equivalent, may be used as the BP calibrator.
HEALTHSTATS INTERNATIONAL PTE LTD
T6400 Series
Not in Commercial Distribution

  • 08885014410036 ()


  • Blood pressure ambulatory recorder
The MC3100™ is an oscillometric blood pressure monitor for measuring systolic pressure, diastolic pressure and pulse rate.
HEALTHSTATS INTERNATIONAL PTE LTD
T3100 Series
Not in Commercial Distribution

  • 08885014410029 ()


  • Blood pressure ambulatory recorder
BPro® Ambulatory Blood Pressure Monitoring System is a noninvasive ambulatory blood pressure monitoring (ABPM) system based on arterial tonometry at the radial artery and oscillometry at the upper arm. It is used for measuring systolic pressure, diastolic pressure and pulse rate of adults.
HEALTHSTATS INTERNATIONAL PTE LTD
T6200 Series
Not in Commercial Distribution

  • 08885014410012 ()


  • Blood pressure ambulatory recorder
The BPro® BT is used to capture the pulse wave from the radial artery.
HEALTHSTATS INTERNATIONAL PTE LTD
T6200 series
In Commercial Distribution

  • 08885014410005 ()


  • Blood pressure ambulatory recorder
encevis is a quantitative EEG trending, spike and seizure detection software. encevis is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings.
AIT Austrian Institute of Technology GmbH
1.12
In Commercial Distribution

  • 09120109830122 ()


  • Bioelectrical signal analysis software
encevis is a quantitative EEG trending, spike and seizure detection software. encevis is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings.
AIT Austrian Institute of Technology GmbH
1.6
In Commercial Distribution

  • 09120109830078 ()


  • Bioelectrical signal analysis software
No Description
Osstell AB
Osstell OsstellConnect
In Commercial Distribution

  • 09010522001073 ()


  • Dental treatment application software
The R2*/T2* phantom is a medical device accessory intended to be used as an alternative to human test subject to avoid potential complications for an MRI centre in order to evaluate that the scanning protocol have been correctly set up for the analysis of cardiac R2* and T2* values using the CardiacT2* on 1.5T and 3T MRI scanners. The R2*/T2* Phantom consists of an amber bottle having 09 (nine) plastic tubes (30mL) of 0.8% Agarose (C24H38O19) gel doped with varying known concentrations (0.10 mM to 3.2 mM) of manganese chloride (MnCl2).
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v1.0
In Commercial Distribution

  • 09355529000088 ()
-

  • MRI phantom, test object
Cardiovascular magnetic resonance (CMR) T2 mapping is key to quantifying myocardial inflammation. The T2CMR Phantom is made of nine (9) plastic tubes (30mL) containing different concentrations of nickel chloride (NiCl2) in agarose. T2CMR Phantom is provided to MRI Centres for the verification of T2-mapping stability across different 1.5T and 3T scanners (different manufacturers and models) and to understand the feasibility of delivering a “T2 standard”.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v1.0
In Commercial Distribution

  • 09355529000071 ()
-

  • MRI phantom, test object
The T1CMR Phantom contains a range of nickel chloride in agarose solutions that mimic cardiac T1 and T2 values. T1 measurement is used to calculate the extravascular volume fraction (ECV) to detect diffuse myocardial fibrosis. It is provided to MRI Centres for the verification of T1-mapping stability across different 3.0T scanners (different manufacturers and models) and to understand the feasibility of delivering a “T1 standard”.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v1.0
In Commercial Distribution

  • 09355529000064 ()
-

  • MRI phantom, test object
The T1CMR Phantom contains a range of nickel chloride in agarose solutions that mimic cardiac T1 and T2 values. T1 measurement is used to calculate the extravascular volume fraction (ECV) to detect diffuse myocardial fibrosis. It is provided to MRI Centres for the verification of T1-mapping stability across different 1.5T scanners (different manufacturers and models) and to understand the feasibility of delivering a “T1 standard”.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v1.0
In Commercial Distribution

  • 09355529000033 ()
-

  • MRI phantom, test object
Sealed pack containing 15 vials of varying concentrations (0 mM to 3.2 mM) of aqueous manganese chloride solutions in 10 mM hydrochloride acid solution. It is intended to be used for verification / re-verification of correct MRI scanner sequence configuration for the use of R2-MRI Analysis System (FerriScan)
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v1.0 (15 vials (0 to 3.2 mM))
In Commercial Distribution



  • MRI phantom, test object
No Description
Manus Medical, LLC
B9-18339
In Commercial Distribution

  • 20811870035221 ()
  • 00811870035227 ()


  • Mammographic stereotactic biopsy system
No Description
Manus Medical, LLC
B446MM-B
In Commercial Distribution

  • 20811870031131 ()
  • 00811870031137 ()


  • Mammographic stereotactic biopsy system
No Description
Manus Medical, LLC
B9-18339B
In Commercial Distribution

  • 20811870030714 ()
  • 00811870030710 ()


  • Mammographic stereotactic biopsy system
No Description
Manus Medical, LLC
B9-17972A
In Commercial Distribution

  • 20811870033364 ()
  • 00811870033360 ()


  • Mammographic stereotactic biopsy system
No Description
Manus Medical, LLC
B9-17972
In Commercial Distribution

  • 20811870033258 ()
  • 00811870033254 ()


  • Mammographic stereotactic biopsy system
No Description
Manus Medical, LLC
B9-16261
In Commercial Distribution

  • 00811870031830 ()


  • Mammographic stereotactic biopsy system
No Description
Manus Medical, LLC
B9-15263A
In Commercial Distribution

  • 00811870031649 ()


  • Mammographic stereotactic biopsy system
No Description
Neurovision Medical Products, Inc.
NONE
In Commercial Distribution

  • B006EMGVIEW0 ()


  • Bioelectrical signal analysis software
Swissmeda powered by Carestream Dental
CARESTREAM DENTAL LLC
5944541
In Commercial Distribution

  • 60192155944543 ()
5944541

  • Dental treatment application software
Model 1807 Ambulatory Blood Pressure Recorder w/Bluetooth
VASOMEDICAL, INC.
Model 1807 Kit
In Commercial Distribution

  • 00817980020481 ()
A10-1807-00

  • Blood pressure ambulatory recorder
Model 1805 Ambulatory Blood Pressure Recorder
VASOMEDICAL, INC.
Model 1805 Kit
In Commercial Distribution

  • 00817980020467 ()
A10-1805-00

  • Blood pressure ambulatory recorder
Ambulatory Blood Pressure Recorder w/Bluetooth
VASOMEDICAL, INC.
Model 1807
In Commercial Distribution

  • 00817980020061 ()
A10-1807-01

  • Blood pressure ambulatory recorder
Ambulatory Blood Pressure Recorder
VASOMEDICAL, INC.
Model 1805
In Commercial Distribution

  • 00817980020047 ()
A10-0088

  • Blood pressure ambulatory recorder
Model 1806 Ambulatory Blood Pressure Recorder
VASOMEDICAL, INC.
Model 1806 Kit
In Commercial Distribution

  • 00817980020474 ()
A10-1806-00

  • Blood pressure ambulatory recorder
Ambulatory Blood Pressure Recorder
VASOMEDICAL, INC.
Model 1806
In Commercial Distribution

  • 00817980020054 ()
A10-1806-01

  • Blood pressure ambulatory recorder
X-Guide Windows Planning Software 2.3.3
XNAV TECHNOLOGIES LLC
P008296
In Commercial Distribution

  • 00817421020803 ()
P008296

  • Dental treatment application software
No Description
BLUE SKY BIO LLC
Blue Sky Plan Software
In Commercial Distribution

  • 00815131026412 ()


  • Dental treatment application software
No Description
BLUE SKY BIO LLC
4.12
In Commercial Distribution

  • 00815131026726 ()
BSP

  • Dental treatment application software
No Description
R.J.L. SCIENCES, INC.
BC (Body Composition Software) Segmental
In Commercial Distribution

  • B202BCSEG0 ()
BCSEG

  • Bioelectrical signal analysis software
No Description
R.J.L. SCIENCES, INC.
BC (Body Composition Software)
In Commercial Distribution

  • B202BC0 ()
BC

  • Bioelectrical signal analysis software
No Description
Swissmeda AG
2.16
Not in Commercial Distribution

  • 07629999685093 ()


  • Dental treatment application software
No Description
Swissmeda AG
2.19.0
In Commercial Distribution

  • 07629999628410 ()


  • Dental treatment application software
No Description
Swissmeda AG
2.17.1
In Commercial Distribution

  • 07629999614178 ()


  • Dental treatment application software
No Description
Swissmeda AG
2.15.4
In Commercial Distribution

  • 07629999065512 ()


  • Dental treatment application software
No Description
Swissmeda AG
2.20.0
In Commercial Distribution

  • 07629999062177 ()


  • Dental treatment application software
No Description
Swissmeda AG
2.15.3
Not in Commercial Distribution

  • 07629999061569 ()


  • Dental treatment application software
No Description
Swissmeda AG
2.15.2
Not in Commercial Distribution

  • 07629999057654 ()


  • Dental treatment application software
No Description
Swissmeda AG
2.15.1
Not in Commercial Distribution

  • 07629999056985 ()


  • Dental treatment application software
No Description
Swissmeda AG
2.15
Not in Commercial Distribution

  • 07629999056220 ()


  • Dental treatment application software
No Description
Swissmeda AG
2.14.3
Not in Commercial Distribution

  • 07629999054356 ()


  • Dental treatment application software
No Description
Swissmeda AG
2.14.2
Not in Commercial Distribution

  • 07629999052505 ()


  • Dental treatment application software
No Description
Swissmeda AG
2.14.1
Not in Commercial Distribution

  • 07629999052109 ()


  • Dental treatment application software
No Description
Swissmeda AG
2.14
Not in Commercial Distribution

  • 07629999048713 ()


  • Dental treatment application software
PXL Intraoral Camera
Digital Doc LLC
PXL-1000
In Commercial Distribution

  • 00813557020243 ()
PXL-1000

  • Intraoral camera
IRIS X90 Intraoral Camera
Digital Doc LLC
X90
In Commercial Distribution

  • 00813557020205 ()
IRIS-X90

  • Intraoral camera
IRIS X80 Intraoral Camera
Digital Doc LLC
X80
In Commercial Distribution

  • 00813557020144 ()
IRIS-X80

  • Intraoral camera
IRIS USB 2.0 Intraoral Camera
Digital Doc LLC
Iris-1000
In Commercial Distribution

  • 00813557020007 ()
IRIS-1000

  • Intraoral camera
No Description
SHOEBOX Ltd
SHOEBOXAUDIOMETER
In Commercial Distribution

  • B348SHOEBOXAUDIOMETER0 ()


  • Tone audiometer
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