8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ULTEC THIN HYDROCOLLOID DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
LYSUS INFUSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only)
FDA 510(k)
FDA Class 2
·Orthopedic
SEE H10
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 17, 2020
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·February 9, 2013
EVERCROSS PTA BALLOON
FDA Adverse Event
Injury
·EV3 INC.·Product code DQY·January 4, 2011
26GA X 1/2 INCH NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON·Product code FPA·July 17, 2014
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024