8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
QUANTEX IGG
FDA 510(k)
FDA Class 2
·Immunology
SURGISTAR
FDA UDI
SURGISTAR, INC.·00878799003164·
VISION(TM) HEMOGLOBIN
FDA 510(k)
FDA Class 2
·Hematology
OCCLUSION BALLOON
FDA 510(k)
FDA Class 2
·Cardiovascular
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·February 14, 2013
MINI-CAP, DISCONNECT W/PVP-1SOLUTION
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·January 17, 2011
4.5MM LCP® PROXIMAL FEMUR PLATE 4 HOLES/175MM-LEFT
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HRS·July 28, 2014
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021