7 results
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19ms
·
Sources: EU EUDAMED, US FDA
USHER'S MARLEX TUBULAR MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoliosis System, KANEDA SR Anterior Spinal System, M-2 Anterior Plate System, MOUNTAINEER Laminoplasty System, PROFILE Anterior Thoracolumbar Plate System, UNIVERSITY PLATE Anterior System, VIPER F2 Facet Fixation System
FDA 510(k)
FDA Unclassified
·Unknown
CLEARFIL MAJESTY POSTERIOR PLT
FDA 510(k)
FDA Class 2
·Dental
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·January 13, 2014
REPLY
FDA Adverse Event
Injury
·SORIN CRM S.R.L.·Product code NVZ·October 12, 2012
V200 VENTILATOR CONVERTED
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·August 10, 2010
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025