10 results
·
35ms
·
Sources: EU EUDAMED, US FDA
XIMATRON/CT OPTION
FDA 510(k)
FDA Class 2
·Radiology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756370592·HEMORRHOID PACK
RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SIMPLICITY INFUSER INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·January 11, 2013
BAGLEY STONE RETRIEVAL HELICAL BASKET
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code FFL·November 30, 2010
UNKNOWN PUMP
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·July 2, 2014
SYNFIX® EVOLUTION AIMING DEVICE HOLDER
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWA·November 5, 2019
SYNFIX® EVOLUTION AIMING DEVICE/17MM & 19MM
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code OVD·November 5, 2019
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