7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
EXPRESSEYE
FDA 510(k)
FDA Class 2
·Neurology
Exsomed Wrist Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
EXPEDIUM SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 7, 2013
CAPSURE SP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·August 8, 2014
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026