10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
DRAINING-WOUND MGMT. SYSTEM
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743595·LEVAMED ANKLE SUPPORT SAND II
CT-GUIDE NEEDLE GUIDANCE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ONE TOUCH BASIC ENHANCED METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·July 28, 2009
NIAGARA DIALYSIS CATHETER KIT 13.5 F X 24 CM (SHORT-TERM)
FDA Adverse Event
Malfunction
·C.R. BARD INC. (BASD)·Product code MPB·March 21, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
1644487-2008-00513
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·February 29, 2008
HANCOCK AORTIC BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code DYE·November 8, 2019
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018