9 results
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34ms
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Sources: EU EUDAMED, US FDA
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