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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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Black & Black Surgical - 00840329829575

LIPO AI CANNULA - 150MM, 14GA X 15CM, LUER LOCK
BLACK & BLACK SURGICAL, INC.
B8X-LAI-150-LL
In Commercial Distribution

  • 00840329829575 ()
B8X-LAI-150-LL

  • Liposuction system cannula, single-use

NA - 07630031759153

Novaloc® Matrix Housing Extraction Instrument, stainless steel/AI
Institut Straumann AG
Non-invasive Instruments
In Commercial Distribution

  • 07630031759153 ()
2010.751-NOV

  • Dental precision attachment fitting/adjustment tool

NA - 07630031759139

Novaloc® Processing Insert Removal Instrument, stainless steel/AI
Institut Straumann AG
Non-invasive Instruments
In Commercial Distribution

  • 07630031759139 ()
2010.731-NOV

  • Dental precision attachment fitting/adjustment tool

NA - 07630031759047

Optiloc® Matrix Housing Extraction Instrument, stainless steel/AI
Institut Straumann AG
Non-invasive Instruments
In Commercial Distribution

  • 07630031759047 ()
3202.0003-OPT

  • Dental precision attachment fitting/adjustment tool

Bot Image, Inc. - 00860009082625

ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted GE Platform
Bot Image, Inc.
ProstatID™
In Commercial Distribution

  • 00860009082625 ()


  • MRI image interpretive software

Bot Image, Inc. - 00860009082601

ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted Terrarecon Platform
Bot Image, Inc.
ProstatID™
In Commercial Distribution

  • 00860009082601 ()


  • MRI image interpretive software

Bot Image, Inc. - 00860009082618

ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted On-Premise
Bot Image, Inc.
ProstatID™
In Commercial Distribution

  • 00860009082618 ()
580SW.01

  • MRI image interpretive software

QP-Prostate® CAD - 08437021468168

QP-Prostate® CAD is an artificial intelligence-based Computed Aided Detection and Diagnosis (CADe/CADx) image processing software. QP-Prostate® CAD uses AI-based algorithms trained with pathology data to detect suspicious lesions for clinically significant prostate cancer. The device automatically detects and identifies suspected lesions in the prostate gland based on bi-parametric prostate MRI and provides marks over regions of the images that may contain suspected lesions. There are two possible markers that are provided in the different colors suggesting different levels of suspicion of clinically significant prostate cancer (moderate or high suspicion level).
QUIBIM SOCIEDAD LIMITADA.
1.1
In Commercial Distribution

  • 08437021468168 ()


  • MRI image interpretive software

QP-Prostate® CAD - 08437021468120

QP-Prostate® CAD is an artificial intelligence-based Computed Aided Detection and Diagnosis (CADe/CADx) image processing software. QP-Prostate® CAD uses AI-based algorithms trained with pathology data to detect suspicious lesions for clinically significant prostate cancer. The device automatically detects and identifies suspected lesions in the prostate gland based on bi-parametric prostate MRI and provides marks over regions of the images that may contain suspected lesions. There are two possible markers that are provided in the different colors suggesting different levels of suspicion of clinically significant prostate cancer (moderate or high suspicion level).
QUIBIM SOCIEDAD LIMITADA.
1.0
In Commercial Distribution

  • 08437021468120 ()


  • MRI image interpretive software

intelliPATH FLX Automated Slide Staining System - 00847627031716

No Description
BIOCARE MEDICAL LLC
IPS0001US
In Commercial Distribution

  • 00847627031716 ()


  • Microscope slide maker/digital imaging analyser IVD

Paige Prostate - 00860007599118

Paige Prostate is a software only device intended to assist pathologists in the detection of foci that are suspicious for cancer during the review of scanned whole slide images (WSI) from prostate needle biopsies prepared from hematoxylin & eosin (H&E) stained formalin-fixed paraffin embedded (FFPE) tissue. After initial diagnostic review of the WSI by the pathologist, if Paige Prostate detects tissue morphology suspicious for cancer, it provides coordinates (X,Y) on a single location on the image with the highest likelihood of having cancer for further review by the pathologist.
PAIGE.AI, INC.
1.X
In Commercial Distribution

  • 00860007599118 ()


  • Histology/cytology/microbiology image-analysis interpretive software IVD

AISight Dx - 00860006696221

No Description
PathAI, Inc.
11124001
In Commercial Distribution

  • 00860006696221 ()


  • Histology/cytology/microbiology image-analysis interpretive software IVD

VIRTUOSO System for IHC - 04015630985043

No Description
VENTANA MEDICAL SYSTEMS, INC.
v5
In Commercial Distribution

  • 04015630985043 ()
06324444001

  • Histology/cytology/microbiology image-analysis interpretive software IVD

ColonPRO™ 4.0 - 08055060110376

No Description
LINKVERSE SRL
4.0.1-S
In Commercial Distribution

  • 78055060110375 ()
  • 08055060110376 ()
CPRO401S-US

  • Endoscopic video image interpretive software

ColonPRO™ 4.0 - 08055060110345

Software to be used in GI Genius™ systems.
LINKVERSE SRL
4.0.1
In Commercial Distribution

  • 78055060110344 ()
  • 08055060110345 ()
CPRO401-US

  • Endoscopic video image interpretive software

ColonPRO™ 4.0 - 08055060110291

No Description
LINKVERSE SRL
CPRO40.US
In Commercial Distribution

  • 78055060110290 ()
  • 08055060110291 ()


  • Endoscopic video image interpretive software

FUJIFILM - 04547410541199

This software is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. This software is used with standard White Light Imaging (WLI) and Linked Color Imaging (LCI) endoscopy imaging. This software is not intended to replace clinical decision making.
FUJIFILM CORPORATION
EW10-EC02
In Commercial Distribution

  • 04547410541199 ()


  • Endoscopic video image interpretive software

EndoScreener - 06973770840012

No Description
Chengdu Wision Medical Device Co., Ltd.
WIPD01
In Commercial Distribution

  • 06973770840012 ()


  • Endoscopic video image interpretive software

Ibex Prostate Detect - 07290019124016

Ibex Prostate Detect is a software only device intended to analyze scanned histopathology whole slide images (WSIs) from prostate core needle biopsies (PCNB) prepared from hematoxylin & eosin (H&E) stained formalin-fixed paraffin embedded (FFPE) tissue. The device is intended to identify cases initially diagnosed as benign for further review by a pathologist. If Ibex Prostate Detect detects tissue morphology suspicious for prostate adenocarcinoma (AdC), it provides case- and slide-level alerts (flags) which includes a heatmap of tissue areas in the WSI that is likely to contain cancer. Ibex Prostate Detect is intended to be used with slide images digitized with Philips Ultra Fast Scanner and visualized using the Ibex Prostate Detect user interface. Ibex Prostate Detect outputs are not intended to be used on a standalone basis for diagnosis, to rule out prostatic AdC or to preclude pathological assessment of WSIs according to the standard of care.
IBEX MEDICAL ANALYTICS LTD
3.1-US
In Commercial Distribution

  • 07290019124016 ()


  • Histology/cytology/microbiology image-analysis interpretive software IVD

CADDIE - 15065010840024

CADDIE is cloud based artificial intelligence medical device software. CADDIE interfaces with the video feed generated by an endoscopic video processor during a colonoscopy procedure. The software is intended to be used by trained and qualified healthcare professionals as an accompaniment to video endoscopy for the purpose of drawing attention to regions with visual characteristics consistent with colonic mucosal lesions (such as polyps and adenomas). CADDIE analyses the data from the endoscopic video processor in real-time and provides information to aid the endoscopist in detecting suspected colorectal polyps, if they are in the field of view of the endoscope. The areas highlighted by CADDIE are not to be interpreted as definite polyps or adenomas. The responsibility to make a decision as to whether or not a highlighted region contains a polyp or is an adenoma lies with the user. The endoscopist is responsible for reviewing CADDIE suspected polyp areas and confirming the presence or absence of a polyp and its classification based on their own medical judgement.
ODIN MEDICAL LIMITED
v1.4.x
In Commercial Distribution

  • 15065010840024 ()


  • Endoscopic video image interpretive software

Stethophone Pro - 00860011561729

Smartphone stethoscope software application with AI for iPhones - Rx only
Sparrow Acoustics Inc.
3.x.x
In Commercial Distribution

  • 00860011561729 ()


  • Electronic acoustic stethoscope

Millennium - 00190776189402

LED Lightsource with port light turrent: AI Wf Storz ympus
Avalign Technologies, Inc.
72-983000
In Commercial Distribution

  • 00190776189402 ()


  • Endoscopic light source unit, line-powered

Millennium - 00190776209315

ADAPTERSNAP ON AI TO STORZ ADAPTER AND STRYKER TO STORZ
Avalign Technologies, Inc.
72-5251ACMIST
In Commercial Distribution

  • 00190776209315 ()


  • Luer/non-ISO80369-standardized linear connector, reusable

Liquichek - 00847661003793

Liquichek Reticulocyte Control (A-I) Bilevel MiniPak (An assayed reticulocyte control.)
BIO-RAD LABORATORIES, INC.
915X
In Commercial Distribution

  • 00847661003793 ()
915X

  • Reticulocyte count IVD, control

Liquichek - 00847661003786

Liquichek Reticulocyte Control (A-I) Level 2 (An assayed reticulocyte control.)
BIO-RAD LABORATORIES, INC.
917
In Commercial Distribution

  • 00847661003786 ()
917

  • Reticulocyte count IVD, control

Liquichek - 00847661003779

Liquichek Reticulocyte Control (A-I) Level 1 (An assayed reticulocyte control.)
BIO-RAD LABORATORIES, INC.
916
In Commercial Distribution

  • 00847661003779 ()
916

  • Reticulocyte count IVD, control

N Apolipoprotein Standard Serum - 00842768011535

Calibration of apolipoprotein A-I and B assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446466
In Commercial Distribution

  • 00842768011535 ()
  • 00842768018602 ()
OUPG09

  • Plasma protein IVD, calibrator

Quantum ® - 05060434420756

Quantum Pump Frame 2 - Cheltenham
SPECTRUM MEDICAL LIMITED
QPF2
In Commercial Distribution

  • 05060434420756 ()
51-000025-00

  • Cardiopulmonary bypass system roller pump

Quantum ® - 05060434420749

Quantum Pump Frame 1 - Blackpool
SPECTRUM MEDICAL LIMITED
QPF1
In Commercial Distribution

  • 05060434420749 ()
51-000024-00

  • Extracorporeal blood gas/pH monitor

GN Hearing - 05708296136995

AUD SHOE QUANTUM ST-GRA COMPL
Gn Hearing A/S
511-004-000-06
In Commercial Distribution

  • 05708296136995 ()


  • Hearing aid/implant system functionality-enhancing device

GN Hearing - 05708296136988

AUD SHOE QUANTUM GRA COMPL
Gn Hearing A/S
511-004-000-03
In Commercial Distribution

  • 05708296136988 ()


  • Hearing aid/implant system functionality-enhancing device

Unitron - 00698764455831

Quantum E W 13 Dir
Unitron Hearing Ltd
063-5633-01
In Commercial Distribution

  • 00698764455831 ()
063-5633-01

  • Air-conduction hearing aid, in-the-ear

Unitron - 00698764455824

Quantum E W 312 Dir
Unitron Hearing Ltd
063-5632-01
In Commercial Distribution

  • 00698764455824 ()
063-5632-01

  • Air-conduction hearing aid, canal

Unitron - 00698764455817

Quantum E W 312 Omni
Unitron Hearing Ltd
063-5631-01
In Commercial Distribution

  • 00698764455817 ()
063-5631-01

  • Air-conduction hearing aid, canal

Unitron - 00698764445436

Quantum E M Mica Beige
Unitron Hearing Ltd
050-5577-D5
In Commercial Distribution

  • 00698764445436 ()
050-5577-D5

  • Air-conduction hearing aid, behind-the-ear

Unitron - 00698764445412

Quantum E M Silver Mist
Unitron Hearing Ltd
050-5577-68
In Commercial Distribution

  • 00698764445412 ()
050-5577-68

  • Air-conduction hearing aid, behind-the-ear

Unitron - 00698764445399

Quantum E M Light Gray
Unitron Hearing Ltd
050-5577-05
In Commercial Distribution

  • 00698764445399 ()
050-5577-05

  • Air-conduction hearing aid, behind-the-ear

Unitron - 00698764444712

Quantum E S Silver Mist
Unitron Hearing Ltd
050-5576-68
In Commercial Distribution

  • 00698764444712 ()
050-5576-68

  • Air-conduction hearing aid, behind-the-ear

Unitron - 00698764444682

Quantum E S Trans. Blue
Unitron Hearing Ltd
050-5576-37
In Commercial Distribution

  • 00698764444682 ()
050-5576-37

  • Air-conduction hearing aid, behind-the-ear

Unitron - 00698764444675

Quantum E S Trans. Red
Unitron Hearing Ltd
050-5576-36
In Commercial Distribution

  • 00698764444675 ()
050-5576-36

  • Air-conduction hearing aid, behind-the-ear
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