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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NIBP blood pressure connection/single tube/infant + newborn/BP16-BP56/2.5m /NEW Partssource
Unimed Medical Supplies, Inc.
HSN-16-56
In Commercial Distribution

  • 06945664877299 ()


  • Blood pressure cuff, reusable
Reusable SpO2 Sensor/Nellcor/ New Adjustable Hinge Finger Clip/Adult/1.1M/DB9M
Unimed Medical Supplies, Inc.
U403NC-01XP
In Commercial Distribution

  • 06945664828697 ()


  • Pulse oximeter probe, reusable
Reusable SpO2 Sensor/Nellcor/ New Finger Clip/Adult/Scilicone Shield/1.1M/DB9M
Unimed Medical Supplies, Inc.
U403L-01XP
In Commercial Distribution

  • 06945664828666 ()


  • Pulse oximeter probe, reusable
NEW Burn Stop 8"x8" dressing 50/case (REF BSD400R); BD Gel
WATER-JEL TECHNOLOGIES, L.L.C.
BSD400.02.000
In Commercial Distribution

  • 00743537000623 ()
  • 00743537000357 ()
BSD400.02.000

  • Synthetic polymer burn dressing, gel-coated
Repetitive blood oxygen probe/Nellcor-oximax/finger clip/adult / 1.1m /103X/NEW Partssource
Unimed Medical Supplies, Inc.
U403-01P(NPS)
In Commercial Distribution

  • 06945664859684 ()


  • Pulse oximeter probe, reusable
New handle, Alligator, with spike, PE coated, Two Wire, 2.2*1800 mm
Micro-Tech (Nanjing) Co., Ltd.
SCNBF13-10122180
In Commercial Distribution

  • 56932503540648 ()
  • 46932503540641 ()
  • 66932503540645 ()
  • 76932503540642 ()

  • Lumen/Inner Diameter: 2.8 Millimeter
  • Length: 180 Centimeter


  • Flexible endoscopic biopsy forceps, single-use
No Description
CORTECHS LABS INC
NQ BT
In Commercial Distribution

  • 00860000004824 ()


  • MRI system application software
Xoran Workstation is an image processing and viewing software for use with compatible radiographic data. The workstation software provides tools for image processing, viewing, interpretation, annotation, clinical review, analysis, distribution, archival, printing, and administrative reporting by healthcare professionals.
XORAN TECHNOLOGIES LLC
v.5
In Commercial Distribution

  • 00860008443717 ()


  • Diagnostic x-ray digital imaging system workstation application software
Localization and characterization of thyroid ultrasound images.
SEE-MODE TECHNOLOGIES PTE. LTD.
See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
In Commercial Distribution

  • 00860006305727 ()


  • Ultrasound imaging system application software
Analysis and reporting of vascular ultrasound images
SEE-MODE TECHNOLOGIES PTE. LTD.
AVA (Augmented Vascular Analysis)
In Commercial Distribution

  • 00860006305703 ()


  • Ultrasound imaging system application software
MediScout® is an augmented reality accessory to clinical ultrasound (US) systems, with the ability to holographically display the US image for the user as well as provide procedural annotation and a teleprodecural function for remote practitioner collaboration.
Mediview Xr, Inc.
MS-100-1001
In Commercial Distribution

  • 00860006066307 ()


  • Ultrasound imaging system application software
Framewise Integrated Real-Time MRI Monitoring
Turing Medical Technologies Inc
v5
In Commercial Distribution

  • 00860004785101 ()

  • Length: 155 Millimeter
  • Width: 65 Millimeter
  • Height: 206 Millimeter
FIRMM®

  • MRI system application software
The Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2DTTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5- Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC). The Caption Interpretation Automated Ejection Fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation. The Caption Interpretation Automated Ejection Fraction Software is indicated for use in adult patients.
CAPTION HEALTH, INC.
0.10, 0.11, 1.1, 1.2, 1.3, 1.4
Not in Commercial Distribution

  • 00860003586303 ()
511-00003

  • Ultrasound imaging system application software
The Koios DS Breast system is designed to assist qualified interpreting physicians in analyzing breast ultrasound images by providing a system generated categorical output that aligns with or exceeds the sensitivity and specificity of radiologist chosen BI-RADS categorizations using computer vision and machine learning techniques. Koios DS Breast may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software includes tools that allow users to adjust, measure and document images, and output into a structured report.
KOIOS MEDICAL, INC.
2.x
In Commercial Distribution

  • 00860002545707 ()


  • Ultrasound imaging system application software
Disposable snap that snaps onto a Jamshidi for instrument tracking.
TrackX Technology, LLC
HANG-TEN SNAP
Not in Commercial Distribution

  • 00860099000899 ()
  • 00860099000882 ()
TX-3-3070

  • Diagnostic x-ray digital imaging system workstation application software
Disposable snap that snaps onto a Jamshidi for instrument tracking. Instrument Tracker .125 IN (previously known as Snap 2 or 12)
TrackX Technology, LLC
T SNAP
Not in Commercial Distribution

  • 00860099000813 ()
  • 00860099000875 ()
TX-3-3038

  • Diagnostic x-ray digital imaging system workstation application software
Optical Tracker Snap 11 0.090 IN (previously known as Snap 1)
TrackX Technology, LLC
Snap 11
Not in Commercial Distribution

  • 00860099000806 ()
TX-3-3036

  • Diagnostic x-ray digital imaging system workstation application software
The AS-OBGYN Information System is a PACS system that automates the managment of patient information. It is intended to be used by obstetricians, gynecologists, perinatologists, radiologists, and cardiologists.
Asw Software, LLC
10
In Commercial Distribution

  • 00860010575307 ()


  • Ultrasound imaging system application software
The STAR Apollo Mapping System is a cardiac mapping method that is based on proprietary algorithms developed to identify localized sources of atrial activation during AF. The STAR Apollo Mapping System does not aim to elucidate the mechanism of AF, rather it seeks to reveal the anatomical location of regions where activation may be originating from, regardless of mechanism. This is based on a very simple and fundamental principle that the source of activation will have activation emerging from it in multiple directions, but not progressing towards it.
Rhythm AI Inc.
STAR Apollo Mapping System
In Commercial Distribution

STAR Apollo Mapping System

  • Cardiac mapping system application software
The STAR Apollo Mapping System is a cardiac mapping method that is based on proprietary algorithms developed to identify localized sources of atrial activation during AF. The STAR Apollo Mapping System does not aim to elucidate the mechanism of AF, rather it seeks to reveal the anatomical location of regions where activation may be originating from, regardless of mechanism. This is based on a very simple and fundamental principle that the source of activation will have activation emerging from it in multiple directions, but not progressing towards it.
Rhythm AI Inc.
STAR Apollo Mapping System
Not in Commercial Distribution

  • 00860009793507 ()
STAR Apollo Mapping System

  • Cardiac mapping system application software
TrackX device that consists of a non-sterile Snap component that mates with retro-reflective spheres to create a unique SNAP that enables physicians to more adequately utilize pins, such as the TrackX Hex Pins, as a Home Base.
TrackX Technology, LLC
TrackX HOME BASE VS SNAP
In Commercial Distribution

  • 00857088008943 ()
TX-3-4314

  • Diagnostic x-ray digital imaging system workstation application software
TrackX adapter that enables physicians to more adequately utilize the INSIGHT BASE-5L SNAP on their surgical instrument.
TrackX Technology, LLC
TrackX SE RETRACT-ADAPT 5L - MJF VS
In Commercial Distribution

  • 00857088008875 ()
TX-3-4300

  • Diagnostic x-ray digital imaging system workstation application software
TrackX adapter that enables physicians to more adequately utilize the INSIGHT BASE-6.5L SNAP on their surgical instrument.
TrackX Technology, LLC
TrackX SE RETRACT-ADAPT 6.5L - MJF VS
Not in Commercial Distribution

  • 00857088008851 ()
TX-3-4273

  • Diagnostic x-ray digital imaging system workstation application software
TrackX adapter that enables physicians to more adequately utilize the INSIGHT BASE-NV/AT DISC PREP SNAP on their surgical instrument.
TrackX Technology, LLC
TrackX AT INSERT-ADAPT - MJF VS
In Commercial Distribution

  • 00857088008820 ()
TX-3-4229

  • Diagnostic x-ray digital imaging system workstation application software
TrackX adapter that enables physicians to more adequately utilize the INSIGHT BASE-5L SNAP on their surgical instrument.
TrackX Technology, LLC
TrackX NV RETRACT-ADAPT - MJF VS
In Commercial Distribution

  • 00857088008813 ()
TX-3-4201

  • Diagnostic x-ray digital imaging system workstation application software
TrackX single-use adapter base that enables physicians to more adequately utilize an INSIGHT-ARRAY on their surgical, disc prep instrument.
TrackX Technology, LLC
TrackX Insight Base - NV/AT Disc Prep
In Commercial Distribution

  • 00857088008806 ()
610-3TX

  • Diagnostic x-ray digital imaging system workstation application software
TrackX reusable adapter that enables physicians to calibrate retractors with a distal blade diameter of 21mm with the Calibrator 2.0.
TrackX Technology, LLC
ACCESS-CALIBRATOR CUP 1
In Commercial Distribution

  • 00857088008790 ()
303-3TX

  • Diagnostic x-ray digital imaging system workstation application software
The device is a general surgical instrument: a non-sterile, reusable T-Handle instrument, with a MOD Hudson-style quick-connect.
TrackX Technology, LLC
TrackX Hudson MOD T-Handle
In Commercial Distribution

  • 00857088008783 ()
1005-3TX

  • Diagnostic x-ray digital imaging system workstation application software
The device is a general surgical instrument: a non-sterile, reusable T-Handle instrument, with a 1/4" square-style quick-connect.
TrackX Technology, LLC
TrackX 1/4" Square T-Handle
In Commercial Distribution

  • 00857088008776 ()
1004-3TX

  • Diagnostic x-ray digital imaging system workstation application software
The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system.
TrackX Technology, LLC
ASC PROCEDURE KIT 1
In Commercial Distribution

  • 00857088008769 ()
980-3TX

  • Diagnostic x-ray digital imaging system workstation application software
The device is a general surgical instrument: a non-sterile, reusable T-Handle instrument, with a Hudson-style quick-connect.
TrackX Technology, LLC
TrackX Hudson T-Handle
In Commercial Distribution

  • 00857088008752 ()
1003-3TX

  • Diagnostic x-ray digital imaging system workstation application software
TrackX reusable adapter that enables physicians to calibrate retractors with a distal blade diameter of 26mm with the Calibrator 2.0.
TrackX Technology, LLC
ACCESS-CALIBRATOR CUP 2
In Commercial Distribution

  • 00857088008745 ()
304-3TX

  • Diagnostic x-ray digital imaging system workstation application software
The device is a general surgical instrument: a sterilized, disposable, single use jamshidi like needle.
TrackX Technology, LLC
ACUITY NEEDLE - 15 DIAMOND - 3.2 INNER
In Commercial Distribution

  • 00857088008738 ()
202-4TX

  • Diagnostic x-ray digital imaging system workstation application software
The device consists of a sterile Array component that mates with an INSIGHT Base component to create a unique SNAP that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. The INSIGHT™ ARRAY-VIOLET when assembled with an INSIGHT Base is designed to mount onto the shaft of a cylindrical instrument.
TrackX Technology, LLC
INSIGHT™ ARRAY-VIOLET
In Commercial Distribution

  • 00857088008714 ()
703-3TX

  • Diagnostic x-ray digital imaging system workstation application software
The device is a general surgical instrument: a non-sterile, reusable Pin instrument.
TrackX Technology, LLC
Hex Pin 6mm x 100mm
In Commercial Distribution

  • 00857088008707 ()
205-4TX

  • Diagnostic x-ray digital imaging system workstation application software
TrackX single-use adapter base that enables physicians to more adequately utilize an INSIGHT-ARRAY on their surgical, disc prep instrument.
TrackX Technology, LLC
TrackX Insight Base - DS Disc Prep - MJF VS
In Commercial Distribution

  • 00857088008691 ()
TX-3-4182

  • Diagnostic x-ray digital imaging system workstation application software
TrackX reusable adapter that enables physicians to more adequately utilize the INSIGHT BASE FLEX-25 SNAP on their surgical instrument.
TrackX Technology, LLC
TrackX PE ADAPT - MJF VS
In Commercial Distribution

  • 00857088008677 ()
TX-3-4121

  • Diagnostic x-ray digital imaging system workstation application software
TrackX reusable adapter that enables physicians to more adequately utilize the Insight Base - NV/AT Disc Prep SNAP on their surgical instrument.
TrackX Technology, LLC
TrackX NV INSERT-ADAPT
In Commercial Distribution

  • 00857088008660 ()
TX-3-4089

  • Diagnostic x-ray digital imaging system workstation application software
TrackX single-use adapter base that enables physicians to more adequately utilize an INSIGHT-ARRAY on their surgical, disc prep instrument.
TrackX Technology, LLC
TrackX Insight Base - NV/AT Disc Prep - MJF VS
In Commercial Distribution

  • 00857088008653 ()
TX-3-4079

  • Diagnostic x-ray digital imaging system workstation application software
TrackX single-use adapter base that enables physicians to more adequately utilize an INSIGHT-ARRAY on their surgical, disc prep instrument.
TrackX Technology, LLC
TrackX Insight Base - NV/AT Disc Prep - MJF
Not in Commercial Distribution

  • 00857088008646 ()
TX-3-4166

  • Diagnostic x-ray digital imaging system workstation application software
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