7 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SIPHONGUARD CSF CONTROL DEVICE
FDA 510(k)
FDA Class 2
·Neurology
MODELS DM-360 & DM-350-L SINGLE PATIENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ROSA ONE Spine application
FDA 510(k)
FDA Class 2
·Neurology
HEARTWARE® VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Injury
·HEARTWARE, INC·Product code DSQ·March 7, 2013
VIVA XT
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code NIK·August 8, 2014
ASKU
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·February 15, 2011
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026