7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
CULDOCENTESIS TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Guided Growth Plate System Plus
FDA 510(k)
FDA Class 2
·Orthopedic
NAVSTATIONIRAD EMT, VERSION 1.1
FDA 510(k)
FDA Class 2
·Radiology
SPECTRUM INFUSION PUJMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 7, 2014
ACUITY
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code OJX·October 10, 2012
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 15, 2015
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024