9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ORIO-Ti Intervertebral Body Fusion Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
TI-BASE ABUTMENT, 1 CONNECT ABUTMENT
FDA 510(k)
FDA Class 2
·Dental
REJUVENIQUE MODEL #RJV10
FDA 510(k)
FDA Class 2
·Neurology
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FMI·November 29, 2017
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 29, 2014
HUDSON CIRCUIT, PEDIATRIC, HEATED WIRE DUAL LIMB
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CAI·August 10, 2011
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 8, 2013
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025