7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
P.F.C. UNICONDYLAR KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PROFLU+ ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
VECTORVISION CT/FLUORO
FDA 510(k)
FDA Class 2
·Neurology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 11, 2013
QUATTRODE PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·November 23, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 2, 2014
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024