9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
THE TUCKER-SACH FOOT AND TUCKER-SYME FT
FDA 510(k)
FDA Class 1
·Physical Medicine
SYNCHRON® AMYLASE (AMY) REAGENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JFJ·September 21, 2010
Life Sensor Cardiac Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
PIEZOTOME 2
FDA 510(k)
FDA Class 2
·Dental
TENDRIL ST
FDA Adverse Event
Death
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·May 5, 2014
REVO MRI SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWP·October 15, 2012
UNIVERSAL BLOCK TRAY
FDA Adverse Event
Other
·INTEGRA PAIN MANAGEMENT·Product code CAZ·May 20, 2015
Philips Zenition 50, Model Number: 718096
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025