9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON
FDA 510(k)
FDA Class 2
·Cardiovascular
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756391016·LAP CHOLE PACK
PAM-RL
FDA 510(k)
FDA Class 2
·Neurology
PreferX Delivery System
FDA 510(k)
FDA Class 2
·General Hospital
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 11, 2013
NEXGEN LPS-FLEX GSF FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HSA·November 23, 2010
FORTIFY VR, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·July 2, 2014
LOGIC FEMORAL PS CEM RIGHT SZ 4
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 18, 2023
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024