8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
LEECO TESTO-QUANT DIAG. KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Bioplate®
FDA UDI
Bioplate, Inc.·M3848130590·Curved Plate - Ø1.5 mm - 8 hole - 30 mm
CONTIPLEX FX
FDA 510(k)
FDA Class 2
·Anesthesiology
STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WALLFLEX? BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code FGE·May 15, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·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