7 results
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19ms
·
Sources: EU EUDAMED, US FDA
STOCKINETTE, STERILE
FDA 510(k)
FDA Class 1
·Physical Medicine
Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts
FDA 510(k)
FDA Class 2
·Orthopedic
LEICA FL800
FDA 510(k)
FDA Class 2
·Radiology
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 10, 2012
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 27, 2007
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 3, 2013
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