7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
BLOOD TRANSFUSION MICROFILTER
FDA 510(k)
FDA Class 2
·General Hospital
CLINAC 6/100
FDA 510(k)
FDA Class 2
·Radiology
MTS Imipenem-relebactam 0.002/4-32/4 µg/mL
FDA 510(k)
FDA Class 2
·Microbiology
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 6, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 15, 2012
PUMP MMT-511LNAL PRDGM INS CL EN US LN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·August 4, 2010
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024