8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
WOUND-EVAC
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Fibrillar Collagen Wound Dressing
FDA 510(k)
FDA Unclassified
·Unknown
HFN LH 125 DEG 11MM X 340MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HSB·May 15, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
OT ULTRALINK METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·August 24, 2010
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026