9 results
·
34ms
·
Sources: EU EUDAMED, US FDA
ULTRACAST WATERLESS SYNTHETIC RESIN CAST
FDA 510(k)
FDA Class 1
·Physical Medicine
Ultraverse® 018
FDA UDI
Bard Peripheral Vascular, Inc.·00801741055102·Ultraverse® 018 PTA Balloon Dilatation Catheter...
Bioplate®
FDA UDI
Bioplate, Inc.·M3848130520·Screw - Ø1.9 mm x 6 mm
INFINIX-CCI
FDA 510(k)
FDA Class 2
·Radiology
KONICA LASER IMAGER, DRYPRO MODEL 751/752
FDA 510(k)
FDA Class 2
·Radiology
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·May 15, 2014
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·October 31, 2012
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·August 15, 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