7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
UBI MAGIWEL RF-IGM QUANTITATIVE
FDA 510(k)
FDA Class 2
·Immunology
WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553
FDA 510(k)
FDA Unclassified
·Unknown
MODIFICATION OF THE PERCUTAN-BALLOON
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDEAVOR SPRINT RX
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code NIQ·June 19, 2014
RECTANGULAR BONE CURETTE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code FZS·December 21, 2012
AMS 700 INFLATABLE PENILE PROSTHESIS
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code JCW·August 11, 2010
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024