8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CEMENT SPACERS
FDA 510(k)
FDA Class 1
·Ophthalmic
SYNCHRON® AMYLASE (AMY) REAGENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JFJ·September 21, 2010
L080 SERIES LIQUID CHROMATOGRAPH
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AURO-BRUSH
FDA 510(k)TENDRIL SDX
FDA Adverse Event
Death
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·May 5, 2014
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·October 15, 2012
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·May 22, 2015
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025