7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MICRO SURGICAL INSTRUMENT SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MEDIPART BACTERIA FILTER MP-30X
FDA 510(k)
FDA Class 2
·Anesthesiology
SALON -BODY TANNING BED
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·June 19, 2014
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 19, 2010
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
Malfunction
·INVAMEX·Product code IKX·December 22, 2012
VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 9, 2015