7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
SWIRL - A PRE-MOISTENED CLEANING TISSUE FOR EYES
FDA 510(k)
FDA Class 1
·Ophthalmic
EMG REPORT GENERATOR
FDA 510(k)
FDA Class 2
·Neurology
CARHILL ONE-WAY RESUSCITATION VALVE
FDA 510(k)
FDA Class 2
·Anesthesiology
UNKNOWN DEPUY 62X28 10DEGREE DURALOC LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.-1818910·Product code KWY·June 16, 2014
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·December 15, 2012
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 19, 2010
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024