8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
GENESIS TM FETAL SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
EMIT PROCAINAMIDE CONTROL SET
FDA 510(k)
FDA Class 1
·Clinical Toxicology
Sweden & Martina Surgical Tray (Model ZSHORTY-INT)
FDA 510(k)
FDA Class 2
·General Hospital
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code KWA·June 18, 2014
M2A MODULAR HEAD COMPONENT 38 MM HEAD DIAMETER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·October 25, 2010
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·November 7, 2012
Hand Pack, part number AMS3640 Hand Pack, part number AMS4213(A Hand Pack, part number AMS4311(A Hand Pack, part number AMS5343 Hand Pack., part number PSS1843(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024