10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
WISE IMAGE MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 1
·Radiology
TATTOOSTAR Y
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ahmed Glaucoma Valve Model FP8
FDA 510(k)
FDA Class 2
·Ophthalmic
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·April 30, 2026
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·December 3, 2025
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·October 16, 2025
OCTRODE
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 4, 2013
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
UNKNOWN·Product code ITJ·July 31, 2014
FORCETRIAD ENERGY PLATFORM
FDA Adverse Event
Injury
·COVIDIEN LP (VALLEYLAB)·Product code GEI·January 14, 2011
Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22-118 ZIMB-22-128 ZIMB-22-70 ZIMB-22-84 ZIMB-22-98 ZIMB-24-108 ZIMB-24-118 ZIMB-24-128 ZIMB-24-70 ZIMB-24-84 ZIMB-24-98 ZIMB-26-108 ZIMB-26-118 ZIMB-26-128 ZIMB-26-70 ZIMB-26-84 ZIMB-26-98 ZIMB-28-108 ZIMB-28-118 ZIMB-28-128 ZIMB-28-70 ZIMB-28-84 ZIMB-28-98 ZIMB-30-108 ZIMB-30-118 ZIMB-30-128 ZIMB-30-70 ZIMB-30-84 ZIMB-30-98 ZIMB-32-108 ZIMB-32-108 ZIMB-32-118 ZIMB-32-128 ZIMB-32-70 ZIMB-32-84 ZIMB-32-98 ZIMB-36-108 ZIMB-36-118 ZIMB-36-128 ZIMB-36-84 ZIMB-36-98
FDA Enforcement
Class II
·Terminated·Cook Inc.·September 23, 2020