36 results
·
60ms
·
Sources: EU EUDAMED, US FDA
DATALINK2000
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·April 21, 2008
GORE® CARDIOFORM SEPTAL OCCLUDER
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code MLV·April 25, 2025
MITRACLIP NTR CLIP DELIVERY SYSTEM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code NKM·March 24, 2023
Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA IntelliSpace PACS are image management systems intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RE, RT, MG, SC, VL, as well as hospital/radiology information systems.
FDA Enforcement
Class II
·Terminated·Philips Healthcare Informatics, Inc.·November 20, 2013
GORE-TEX SUTURE FOR CHORDAE TENDINEAE
FDA Adverse Event
Malfunction
·W. L. GORE & ASSOCIATES, INC.·Product code GAW·June 25, 2021
SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM
FDA Adverse Event
Injury
·GYNESONICS·Product code KNF·August 27, 2025
MEDTRONIC NAVIGATION
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code GEX·December 23, 2020
ALTAIRE MR SYSTEM
FDA Adverse Event
Injury
·FUJIFILM HEALTHCARE CORPORATION·Product code LNH·March 8, 2022
AIRIS ELITE MR SYSTEM
FDA Adverse Event
Injury
·FUJIFILM HEALTHCARE CORPORATION·Product code LNH·March 8, 2022
AIRIS ELITE MR SYSTEM
FDA Adverse Event
Injury
·FUJIFILM HEALTHCARE CORPORATION·Product code LNH·March 8, 2022
NORMAL I.V. FLUSH SYRINGES
FDA Adverse Event
Malfunction
·MEDEFIL, INC.·Product code NGT·October 21, 2010
GORE-TEX® SUTURE
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code GAW·December 16, 2024
MITRACLIP G4 CLIP DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code NKM·August 1, 2022
MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code NKM·December 9, 2019
SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM
FDA Adverse Event
Injury
·GYNESONICS·Product code KNF·August 27, 2025
SPACEOAR SYSTEM
FDA Adverse Event
Injury
·AUGMENIX, INC·Product code OVB·May 15, 2017
IMPELLA
FDA Adverse Event
Death
·ABIOMED, INC. - 1220648·Product code OZD·March 26, 2026
SONATA TRANSCERVICAL FIBROID ABLATION SYSTEM
FDA Adverse Event
Injury
·GYNESONICS·Product code KNF·September 4, 2025
LVIS EVO
FDA Adverse Event
Malfunction
·MICROVENTION, INC.·Product code QCA·May 26, 2023
SYNCHRON LXI 725 CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·November 18, 2011