8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
FLOWTRON AC200/2
FDA 510(k)
FDA Class 2
·Physical Medicine
O.O2 M CALCIUM CHLORIDE SOLUTION
FDA 510(k)
FDA Class 2
·Hematology
ARNOLD-KING PRESSURE DRESSING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HOMECHOICE PRO
FDA Adverse Event
Death
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 16, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
ANIMAS CORP.·Product code LZG·October 15, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·December 15, 2012
GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015