7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MODIFIED SEISMOCARDIOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
TAKE ONE BITE MODIFIED
FDA 510(k)
FDA Class 2
·Dental
PARKER 500
FDA 510(k)
FDA Class 2
·Physical Medicine
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 11, 2013
NEXGEN MIS STEMMED TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·November 23, 2010
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·July 2, 2014
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024