14 results
·
27ms
·
Sources: EU EUDAMED, US FDA
TONICROSS TRICYCLES, MODELS, T0, T1,T2,T3 AND T4.
FDA 510(k)
FDA Class 1
·Physical Medicine
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198574·AK3 Ultra Insert Trial Size 3, 10mm
Flap Fixator, Burr Hole Cover
FDA 510(k)
FDA Class 2
·Neurology
SEGUIN ANNULOPLASTY RING
FDA 510(k)
FDA Class 2
·Cardiovascular
WALLSTENT RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code JCT·March 21, 2025
PREMIER ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code KWQ·August 12, 2011
PREMIER® ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·March 3, 2017
PREMIER® ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 3, 2017
PREMIER® ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 7, 2015
REPLY
FDA Adverse Event
Injury
·SORIN CRM S.R.I.·Product code NVZ·March 1, 2013
ATTAIN ABILITY
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·February 15, 2011
ADAPTA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·August 8, 2014
WALLSTENT? RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025
BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020