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