7 results
·
16ms
·
Sources: EU EUDAMED, US FDA
IQ HDL CHOLESTEROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
Portable X-ray System (Model: MiniX-V, Mini X-S)
FDA 510(k)
FDA Class 2
·Dental
SPIDERFX EMBOLIC PROTECTION DEVICE
FDA Adverse Event
Injury
·COVIDIEN·Product code NTE·June 18, 2014
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·December 20, 2012
ROTH NET - FOREIGN BODY - STANDARD
FDA Adverse Event
Malfunction
·US ENDOSCOPY·Product code KOG·October 20, 2010
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024