9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MINI-IRRIGATION TRAY
FDA 510(k)
FDA Class 2
·General Hospital
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809763498145·MIS Cannulated Screw M, Ø10.5 x 95mm, Ø6.0mm Rod
N/A
FDA UDI
Zimmer, Inc.·00889024135222·
CELLAVISION DM96 WITH THE BODY FLUID APPLICATION
FDA 510(k)
FDA Class 2
·Hematology
SciMoCa
FDA 510(k)
FDA Class 2
·Radiology
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HLTHCARE CORP·Product code FRN·January 3, 2014
FLEXTEND II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 10, 2012
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 26, 2007
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