15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRIFLANGE II ACETABULAR CUP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201503164·Leksell MPS Arc w Counter Scale - ARC GUIDE SLIDE
Myo/Wire II
FDA UDI
A & E MEDICAL CORPORATION·10841291101918·SS Suture, 1 per sleeve
TEMP SCAN
FDA 510(k)
FDA Class 2
·General Hospital
ORTHO DEVELOPMENT BALANCED KNEE TIBIAL TRAY PEGGED
FDA 510(k)
FDA Class 2
·Orthopedic
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·October 8, 2013
CD HORIZON
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·August 11, 2020
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWP·December 29, 2010
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·April 3, 2013
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 15, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code NIQ·May 6, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·July 6, 2020
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPT·July 29, 2025
1000317571-2021-00127
FDA Adverse Event
Injury
·CONVATEC LTD·Product code FRO·March 17, 2021
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·December 18, 2019