52 results
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27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Bluefin Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
MC+ PARTIAL VBR
FDA 510(k)
FDA Class 2
·Orthopedic
NOVEL TAPERED HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
CATALYS LASER
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·January 24, 2024
CATALYS LASER
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·July 28, 2023
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·April 8, 2016
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·April 8, 2016
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·June 3, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·June 29, 2011
CHUCK W/KEY F/COMPACT AIR DRIVE+POWER DR
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·October 6, 2014
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·April 24, 2026
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·October 30, 2023
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·July 31, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 29, 2017
CATALYS SYSTEM
FDA Adverse Event
Injury
·AMO MANUFACTURING USA, LLC·Product code OOE·November 1, 2022
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·January 26, 2026
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 29, 2017
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·July 28, 2023
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·Product code OOE·October 12, 2021
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 12, 2019