8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
BECKMAN ASTRA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Tranquil-L™
FDA UDI
NEXUS SPINE, L.L.C.·B6788220390·17mm Lumbar Shaver Distractor
KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B
FDA 510(k)
FDA Class 2
·Dental
PHENOBARBITAL REAGENT TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GORE® EXCLUDER® AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·May 20, 2014
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·October 9, 2012
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 5, 2015
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