135 results · 107ms · Sources: EU EUDAMED, US FDA

IDx-DR

FDA UDI
Digital Diagnostics Inc.·00860005195626·

Bot Image, Inc.

FDA UDI
Bot Image, Inc.·00860009082625·ProstatID™ MRI Diagnostic Aid for Prostate Canc...

Unfold AI

FDA UDI
Avenda Health, Inc.·00850012642015·The Avenda Health Unfold AI Software is an arti...

Bot Image, Inc.

FDA UDI
Bot Image, Inc.·00860009082618·ProstatID™ MRI Diagnostic Aid for Prostate Canc...

Unfold AI

FDA UDI
Avenda Health, Inc.·00850012642022·The Avenda Health Unfold AI Software is an arti...

Bot Image, Inc.

FDA UDI
Bot Image, Inc.·00860009082601·ProstatID™ MRI Diagnostic Aid for Prostate Canc...

iQuest

FDA UDI
Avenda Health, Inc.·00850012642008·AI SaMD for prostate cancer.

InferRead Lung CT.AI 2.1.2.1

FDA UDI
Infervision US Inc·00850003095004·Computer assisted reading tools designed to aid...

InferRead CT Stroke.AI

FDA UDI
Infervision US Inc·00850003095011·InferRead CT Stroke.AI is a radiological comput...

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Adapta, Versa, Sensia IPG, Relia IPG

INFINITI® Factor II-V Leiden Intellipac® Reagent Module

FDA UDI
AUTOGENOMICS, INC·00850009370112·Genotyping system for the detection of Factor I...

INFINITI® Factor II-V Leiden Amplification Mix

FDA UDI
AUTOGENOMICS, INC·00850009370129·Genotyping system for the detection of Factor I...

INFINITI® Factor II-V Leiden BioFilmChip® Microarray Magazine

FDA UDI
AUTOGENOMICS, INC·00850009370105·Genotyping system for the detection of Factor I...

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD,

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BAUSCH & LOMB PUREVISION (BALAFILCON A) SOFT CONTACT LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BAUSCH & LOMB PUREVISION (BALAFILCON A) SOFT CONTACT LENS

ACPlus Respiratory Assessment

FDA UDI
ACCELERATED CARE PLUS CORP·00858703006344·Software and sensor to provide assessment of re...

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses