39 results · 74ms · Sources: EU EUDAMED, US FDA

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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