10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521
FDA 510(k)
FDA Class 2
·Immunology
EARLE'S BALANCED SALT SOLUTION (EBSS) NO. 210-3000
FDA 510(k)
FDA Class 1
·Hematology
REVOLUTIONFULL FACE MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·January 20, 2025
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·September 9, 2022
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS·Product code LYJ·February 28, 2013
REALIZE ADJ GASTRIC BAND-C
FDA Adverse Event
Injury
·OBTECH MEDICAL SARL_·Product code LTI·February 9, 2011
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 6, 2014
ASCENT SYSTEM-BEARING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·December 28, 2016
Orbitofacial Pack, part number AMS5850(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017