39 results
·
74ms
·
Sources: EU EUDAMED, US FDA
AEH-4 LITHOTRIPSY SYSTEM
FDA Adverse Event
Injury
·NORTHGATE TECHNOLOGIES INC.·Product code FFK·July 10, 2019
7FR FIXEDPIN HEMOSTATIC PROBE
FDA Adverse Event
Injury
·GYRUS ACMI, INC·Product code KNS·August 28, 2020
GYRUS, PK-SP GENERATOR
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC·Product code GEI·April 16, 2020
ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
FDA Enforcement
Class II
·Terminated·Northgate Technologies, Inc.·May 13, 2020
BIPOLAR BLADE, 2MM, STRAIGHT, STANDARD, TYPE A, SMR, 5/PK
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC·Product code GEI·November 25, 2019
CW-USLTA CYBERWAND ADVANCED TRANSDUCER
FDA Adverse Event
Malfunction
·GYRUS ACMI INC·Product code FFK·June 2, 2020
SOLTIVE PRO SUPERPULSED LASER SYSTEM
FDA Adverse Event
Injury
·GYRUS ACMI, INC·Product code GEX·April 14, 2020
LASER FIBERS
FDA Adverse Event
Malfunction
·OLYMPUS SURGICAL TECHNOLOGIES AMERICA·Product code GEX·November 13, 2017
OLYMPUS GENERATOR
FDA Adverse Event
Malfunction
·OLYMPUS SURGICAL TECHNOLOGIES AMERICA·Product code GEI·November 4, 2025
EVIS EXERA LLL COLONOVIDEOSCOPE
FDA Adverse Event
Malfunction
·OLYMPUS SURGICAL TECHNOLOGIES AMERICA·Product code FDF·November 19, 2018
THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP
FDA Adverse Event
Malfunction
·OLYMPUS SURGICAL TECHNOLOGIES AMERICA·Product code GEI·September 29, 2020
SINGLE USE SUCTION VALVE (STERILE)
FDA Adverse Event
Malfunction
·OLYMPUS SURGICAL TECHNOLOGIES AMERICA·Product code EOQ·May 9, 2019
THUNDERBEAT ELECTROSURGICAL UNIT
FDA Adverse Event
Injury
·OLYMPUS SURGICAL TECHNOLOGIES AMERICA·Product code GEI·May 10, 2019
OLYMPUS GIF-H190 GASTROSCOPE
FDA Adverse Event
Malfunction
·OLYMPUS SURGICAL TECHNOLOGIES AMERICA·Product code NWB·June 18, 2019
OLYMPUS
FDA Adverse Event
Malfunction
·OLYMPUS SURGICAL TECHNOLOGIES AMERICA·Product code MNK·April 15, 2019
OLYMPUS SINGLE USE ASPIRATION NEEDLE
FDA Adverse Event
Malfunction
·OLYMPUS SURGICAL TECHNOLOGIES AMERICA·Product code FCG·June 3, 2019
OLYMPUS STONE CRUSHING FORCEPS
FDA Adverse Event
Injury
·OLYMPUS SURGICAL TECHNOLOGIES AMERICA·Product code GCP·March 6, 2020
OLYMPUS
FDA Adverse Event
Malfunction
·OLYMPUS SURGICAL TECHNOLOGIES AMERICA·Product code FJL·March 4, 2020
EMPOWER LASER FIBER 550 MICRON
FDA Adverse Event
Malfunction
·OLYMPUS SURGICAL TECHNOLOGIES AMERICA·Product code GEX·February 3, 2026
VIZISHOT ASPIRATION NEEDLE
FDA Adverse Event
Malfunction
·OLYMPUS SURGICAL TECHNOLOGIES AMERICA·Product code KTI·April 12, 2018