11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
DESENSITRON
FDA 510(k)
FDA Class 2
·Physical Medicine
CoRoent
FDA UDI
Nuvasive, Inc.·00887517809797·Interlock II, 11x17x14mm 30°
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771012443·K-Wires, Single trocar, .028-inch (.7mm) diamet...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704292671·
NA
FDA UDI
KEY SURGICAL, INC.·10849771049026·K-Wires, Single trocar, .028-inch (.7mm) diamet...
HEARTRAK AF
FDA 510(k)
FDA Class 2
·Cardiovascular
Nucleus Image Management System
FDA 510(k)
FDA Class 2
·Radiology
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 3, 2012
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·December 19, 2013
VENTAK PRIZM 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 27, 2010
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019