10 results
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19ms
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Sources: EU EUDAMED, US FDA
PFX SPINOUS PROCESS FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
STREET
FDA 510(k)
FDA Class 2
·Physical Medicine
PRONEX
FDA 510(k)
FDA Class 2
·Radiology
ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system that offers both the fixation devices and instrument in one system. The insertion tool is used with a mallet to tap the tunnel sleeve implant into a counter-bored hole in the bone.
FDA Enforcement
Class II
·Terminated·OrthoPediatrics Corp·September 10, 2014
BRILLIANCE 16 AIR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS (CLEVLAND), INC.·Product code JAK·May 24, 2013
BIPASS DISPOSABLE PUSHER SINGLE PACK
FDA Adverse Event
Injury
·BIOMET SPORTS MEDICINE·Product code HXO·June 17, 2011
JAGWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code EZB·August 22, 2008
VENATECH CONVERTIBLE
FDA Adverse Event
Malfunction
·B.BRAUN MEDICAL SAS·Product code DTK·January 5, 2018
OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, and 10mm. Used with ACL reconstruction system associated surgery.
FDA Enforcement
Class II
·Terminated·OrthoPediatrics Corp·January 1, 2014
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020