925 results
·
103ms
·
Sources: EU EUDAMED, US FDA
PROLENE HERNIA SYSTEM UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·March 9, 2026
ION
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code EOQ·May 10, 2024
BLAKE DRAIN UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GBX·February 2, 2023
J-VAC RESERVOIR UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code JOL·February 2, 2023
i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac troponin I measurements can be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. The cartridge is to be used with the i-Stat Analyzer, but not with the i-Stat Portable Clinical Analyzer or the Philips Medical System (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-Stat System, the cTnl test is to be used by trained health care professionals in accordance with a facility's policies and procedures.
FDA Enforcement
Class II
·Terminated·Abbott Point Of Care Inc.·August 15, 2012
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·March 19, 2024
ION
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code EOQ·May 10, 2024
ION
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code EOQ·December 16, 2024
ION
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code EOQ·June 10, 2025
ION
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code EOQ·September 11, 2024
ION
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code EOQ·April 20, 2023
ION
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code EOQ·July 21, 2025
ION
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code EOQ·April 16, 2025
SOFT-VU
FDA Adverse Event
Malfunction
·ANGIODYNAMICS, INC.·Product code DQO·October 23, 2025
ION
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code EOQ·August 7, 2025
ION
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code EOQ·September 26, 2023
ION
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code EOQ·December 4, 2023
ION
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code EOQ·March 24, 2026
ION
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code EOQ·April 22, 2026
DAVINCI XI
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·March 18, 2025