62 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814589·GENUMEDI SAND SIZE VII
XIA STAINLESS STEEL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
LIGASURE
FDA Adverse Event
Malfunction
·COVIDIEN MEDICAL PRODUCTS·Product code GEI·April 17, 2018
LIGASURE
FDA Adverse Event
Malfunction
·COVIDIEN MEDICAL PRODUCTS·Product code GEI·October 7, 2020
LIGASURE
FDA Adverse Event
Injury
·COVIDIEN MEDICAL PRODUCTS·Product code GEI·July 21, 2018
LIGASURE
FDA Adverse Event
Malfunction
·COVIDIEN MEDICAL PRODUCTS·Product code GEI·February 20, 2018
LIGASURE
FDA Adverse Event
Malfunction
·COVIDIEN MEDICAL PRODUCTS·Product code GEI·November 26, 2018
LIGASURE
FDA Adverse Event
Malfunction
·COVIDIEN MEDICAL PRODUCTS·Product code GEI·June 9, 2021
LIGASURE
FDA Adverse Event
Malfunction
·COVIDIEN MEDICAL PRODUCTS·Product code GEI·February 2, 2018
LIGASURE
FDA Adverse Event
Malfunction
·COVIDIEN MEDICAL PRODUCTS·Product code GEI·November 13, 2018
LIGASURE
FDA Adverse Event
Malfunction
·COVIDIEN MEDICAL PRODUCTS·Product code GEI·April 16, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NKB·May 1, 2014
LIGASURE
FDA Adverse Event
Malfunction
·COVIDIEN MFG DC BOULDER·Product code GEI·April 24, 2020
LIGASURE
FDA Adverse Event
Malfunction
·COVIDIEN MFG DC BOULDER·Product code GEI·March 14, 2019
LIGASURE
FDA Adverse Event
Malfunction
·COVIDIEN MEDICAL PRODUCTS·Product code GEI·June 16, 2021
TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws. The TRESTLE LUXE Anterior Cervical Plating System is intended for use in the anterior cervical spine (C2-C7). Patients with trauma (including fractures), spondylolisthesis, and pseudoarthrosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, tumors, and failed previous fusion.
FDA Enforcement
Class II
·Terminated·Alphatec Spine, Inc.·September 5, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 2, 2012
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·May 9, 2013