7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
OCO PREPARATIONS
FDA 510(k)
FDA Class 1
·Dental
DIRECT IRON REAGENT SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
POLLENEX DIGITAL SPHYGMOMANOMETER BP-2000
FDA 510(k)
FDA Class 2
·Cardiovascular
PLUM XL PLS MIC/MAC
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·April 22, 2014
AC POWER MODULE
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·October 12, 2010
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FPA·December 14, 2012
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