8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CURAY-MATCH PAINT-ON COMPOSITE RESTOR
FDA 510(k)
FDA Class 2
·Dental
LONESTAR
FDA UDI
Orthofix US LLC·18257200090358·DIA 4.0MM RESCUE BONE SCREW - 10MM
VC150 VITAL SIGNS MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 27, 2014
15X100MM OPITCAL ACCESS SYSTEM THREADED
FDA Adverse Event
APPLIED MEDICAL·Product code GCJ·November 5, 2012
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2015
THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-451115 14-451120 14-451125 14-451130 . The product is a metallic bone fixation system.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 4, 2020