7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
UNIVERSAL URETHRAL CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MCKERNAN-POTTS GRASPING FORCEPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TRANSIT INFUSION CATHETER (NEUROVASCULAR USE)
FDA 510(k)
FDA Class 2
·Cardiovascular
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 19, 2014
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·February 6, 2013
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·January 4, 2011
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30; b) 3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS35; c) 4.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS40
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024