9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756349482·ENT PACK
BEAUTIBOND MULTI PR PLUS
FDA 510(k)
FDA Class 2
·Dental
MAGNUM
FDA 510(k)
FDA Class 2
·Physical Medicine
MAXISKY 600
FDA Adverse Event
Malfunction
·ARJOHUNTLEIGH MAGOG INC.·Product code FSA·November 23, 2012
DEXTRUS 4135
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·November 22, 2010
ARCHITECT CA 19-9XR
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code NIG·July 2, 2014
NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·July 30, 2014
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015