19 results · 51ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

MINISITE LAPAROSCOPE

FDA Adverse Event
Injury ·IMAGYN MEDICAL, INC.·Product code HET·September 11, 1996

AUTO SUTURE MINISITE 2MM

FDA Adverse Event
Injury ·IMAGYN MEDICAL INC.·Product code GCJ·December 2, 1997

SITESELECT BREAST BIOPSY DEVICE

FDA Adverse Event
Other ·IMAGYN MEDICAL TECHNOLOGIES, INC.·Product code KNW·September 6, 2002

SSD015

FDA Adverse Event
Other ·IMAGYN MEDICAL TECHNOLOGIES, INC.·Product code KNW·September 6, 2002

SITESELECT BREAST BIOPSY DEVICE

FDA Adverse Event
Other ·IMAGYN MEDICAL TECHNOLOGIES, INC.·Product code KNW·September 6, 2002

ECAT PET Scanners (mobile systems), distributed by Siemens Medical Solutions ECAT PET Scanners (mobile systems), and Reveal XL (mobile systems), distributed by CTI Molecular Imagining, Inc. Sceptre and Sceptre XL (mobile systems) distributed by Hitachi Medical Systems America

FDA Recall
Terminated ·CTI PET Systems Inc·Product code KPS·April 5, 2005

O-ARM 1000 IMAGING SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·July 28, 2016

O-ARM 1000 IMAGING SYSTEM 3RD EDITION

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·November 28, 2016

VCL CT BRD VIO 27IN 1 S/A CT-1

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAM·August 11, 2025

LEAD MODEL 304

FDA Adverse Event
Death ·LIVANOVA USA, INC.·Product code LYJ·January 16, 2023

LEAD MODEL 303

FDA Adverse Event
Malfunction ·LIVANOVA USA, INC.·Product code LYJ·August 17, 2022

670G INSULIN PUMP MMT-1780KL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·May 17, 2022

GORE® EXCLUDER® AAA ENDOPROSTHESIS

FDA Adverse Event
Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·November 14, 2022

INTELLIS

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·December 28, 2018

GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

FDA Adverse Event
Injury ·W. L. GORE & ASSOCIATES, INC.·Product code PRL·July 25, 2025

GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS

FDA Adverse Event
Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·March 20, 2024

GORE® EXCLUDER® AAA ENDOPROSTHESIS

FDA Adverse Event
Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·March 20, 2024

GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM

FDA Adverse Event
Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·May 19, 2025

MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MG/DL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·September 9, 2022