8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER
FDA 510(k)
FDA Class 2
·General Hospital
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756663717·ENT PACK
ADMS BIOPSY NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SCISSORS: THOREK, JORGENSEN, FINOCHIETTO
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·June 13, 2014
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·December 7, 2012
ZEPHYR XL DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2010
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015