7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
IRRI-CATH
FDA 510(k)
FDA Class 1
·Anesthesiology
N HIGH SENSITIVITY CRP
FDA 510(k)
FDA Class 2
·Immunology
cNeuro cDAT
FDA 510(k)
FDA Class 2
·Radiology
ESSURE
FDA Adverse Event
Injury
·BAYER·Product code HHS·May 27, 2014
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·November 7, 2012
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·September 14, 2010
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024