8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
CIBA CORNING MAGIC LITE TSH IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981144647·Modular Trial 20x15x7mm, 10 Deg Lordosis, w/ De...
L300 Go System
FDA 510(k)
FDA Class 2
·Neurology
GATEWAY THORACOLUMBAR PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
UNKNOWN DEPUY FEMORAL COMPONENT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·December 10, 2012
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·June 23, 2015
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021