9 results
·
28ms
·
Sources: EU EUDAMED, US FDA
VITLITE (TR7700)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CORDIS MULTICOR II MODEL 402D PACER
FDA 510(k)
FDA Class 3
·Cardiovascular
SEXTANT SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code MCV·October 29, 2009
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING·Product code LXH·December 10, 2010
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 30, 2014
CONSERVE(R) PLUS CUP
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWA·February 15, 2013
COMPUSTIM TRANSMITTER
FDA Adverse Event
Malfunction
·SJM NEUROMODULATION DIVISION·Product code LGW·December 20, 2010
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024