70 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014609539·BERCHTOLD 2" SOFTCARE
ACTIVE ARRAY CATHETER, MODEL CS-2000
FDA 510(k)
FDA Class 2
·Radiology
QUICKVUE DIPSTICK STREP A
FDA 510(k)
FDA Class 1
·Microbiology
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·June 27, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 23, 2014
CELOX GAUZE
FDA Adverse Event
Injury
·MEDTRADE PRODUCTS LIMITED·Product code FRO·February 14, 2023
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·November 18, 2013
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·November 18, 2013
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·July 15, 2020
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·April 27, 2012
DUO FLUID CART
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·December 21, 2017
ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·August 31, 2018
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·April 10, 2018
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 9, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·June 27, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·September 15, 2015
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·August 13, 2020
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·April 8, 2016
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·April 26, 2013