8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
LIDSPLINT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NEW BARD INFECTION CONTROL URINARY DRAINAGE BAG
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FC-1000 FLUOROSCOPIC IMAGING COMPUTER
FDA 510(k)
FDA Class 2
·Radiology
REVO MRI SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWP·June 10, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 12, 2010
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FPA·December 10, 2012
M2A-MAGNUM PF CUP 56ODX50ID
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·February 4, 2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020