9 results
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18ms
·
Sources: EU EUDAMED, US FDA
GENERAL PURPOSE KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Stryker All-PEEK Knotless Anchor System
FDA 510(k)
FDA Class 2
·Orthopedic
CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
EX-PRESS MINI GLAUCOMA SHUNT
FDA Adverse Event
Injury
·OPTONOL, LTD·Product code KYF·April 9, 2014
PUMP MMT-722NAL PRDGM INSULIN CL EN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·October 19, 2010
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·December 20, 2012
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·Product code FWM·September 2, 2021
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·Product code FWM·September 2, 2021
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020