7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
REVOLUTION RADIAL IMMUNODIFFUSION PLATE
FDA 510(k)
FDA Class 1
·Immunology
PIT & FISSURE SEALANT WITH FLUORIDE
FDA 510(k)
FDA Class 2
·Dental
UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
OXIMAX N-560 PULSE OXIMETER
FDA Adverse Event
Malfunction
·MEDIANA·Product code DPZ·March 5, 2014
ENSEAL G2 CURVED JAW
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GEI·November 14, 2012
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·September 8, 2010
ENT Pack, part number AMS3237(A ENT Pack, part number AMS4214
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017