7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
COBAS EIA(TM) PHOTOMETER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS
FDA 510(k)
FDA Class 2
·Ophthalmic
Phoenix 2.4mm Atherectomy Plus System
FDA 510(k)
FDA Class 2
·Cardiovascular
INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·June 18, 2014
SYMPHONY
FDA Adverse Event
Malfunction
·SORIN CRM·Product code NVZ·October 8, 2010
ASR UNI FEMORAL IMPL SIZE 51
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·December 20, 2012
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