37 results
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28ms
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Sources: EU EUDAMED, US FDA
Exo Imaging
Manufacturer
🇺🇸 United States
Exo Imaging, Inc.
FDA registration
Exo Imaging, Inc.·5 products·🇺🇸 United States
Exo Works
FDA UDI
Exo Imaging, Inc.·00850018318013·
Exo Iris
FDA UDI
Exo Imaging, Inc.·00850018318006·Exo Iris is a hand-held, general-purpose diagno...
Exo Iris Ultrasound System
FDA UDI
Exo Imaging, Inc.·00850018318068·Exo Iris Ultrasound System is a procedural pack...
EXO IRIS
FDA Adverse Event
Other
·EXO IMAGING·Product code IYN·November 8, 2024
IMACOR ZURA EVO IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
OXO -IMAGE-INTENSIFIED
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC (LITTLETON)·Product code OXO·June 17, 2020
THERAPY ABLATION CATHETER
FDA Adverse Event
Injury
·IRVINE BIOMEDICAL, A ST. JUDE MEDICAL COMPANY·Product code LPB·May 12, 2010
THERAPY ABLATION CATHETER
FDA Adverse Event
Injury
·IRVINE BIOMEDICAL, A ST. JUDE MEDICAL COMPANY·Product code LPB·May 12, 2010
HEMOSPHERE ALTA ADVANCED MONITORING PLATFORM
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DQK·December 17, 2024
EDWARDS PASCAL PRECISION
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NMK·October 27, 2025
NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.
FDA Recall
Terminated
·Nidek Inc·Product code HKI·August 1, 2013
VERSACROSS CONNECT FOR FARADRIVE
FDA Adverse Event
Injury
·BAYLIS MEDICALE CIE INC·Product code DXF·August 18, 2025
SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.
FDA Recall
Terminated
·Biosense Webster, Inc.·Product code OBJ·September 10, 2015
SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.
FDA Enforcement
Class II
·Terminated·Biosense Webster, Inc.·October 7, 2015
steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.
FDA Enforcement
Class II
·Terminated·EOS Imaging·January 1, 2014
ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Number 9000111773; and MOBELI Dual Grip Grab Handle, ROTH Catalogue Number 14002 25 S, EOS Imaging Catalogue Number 9000111774.
FDA Enforcement
Class II
·Terminated·EOS Imaging·July 5, 2017
EOS System X- ray beam Digital radiography system used in general radiographic examinations.
FDA Enforcement
Class II
·Terminated·EOS Imaging·January 15, 2014