9 results · 34ms · Sources: EU EUDAMED, US FDA

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AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH SMALL #2

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

OLYMPUS XCHF TYPE B180Y1

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Varian Head Frame

FDA 510(k)
FDA Class 2 ·Radiology

SCHOLL FREEZE VERRUCA AND WART REMOVER

FDA Adverse Event
Malfunction ·ORASURE TECHNOLOGIES, INC.·Product code GEH·April 9, 2014

CE INFUSOR LV7, 12 PACK

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·October 22, 2010

MECHANICAL WALKER, ROLLATOR

FDA Adverse Event
GOODBABY·Product code ITJ·December 19, 2012

Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS LIMB SALVAGE SYSTEM

FDA Enforcement
Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025

Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·October 25, 2017