14 results
·
20ms
·
Sources: EU EUDAMED, US FDA
PFC CEMENT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ROI-C Titanium-Coated Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
qXR-Detect
FDA 510(k)
FDA Class 2
·Radiology
ROI-C IMPLANT, UNKNOWN SIZE
FDA Adverse Event
Malfunction
·LDR MEDICAL·Product code OVE·February 4, 2020
ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H6MM 14X17MM
FDA Adverse Event
Malfunction
·LDR MÉDICAL·Product code OVE·April 13, 2020
ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H5MM 14X15.5MM
FDA Adverse Event
Malfunction
·LDR MEDICAL·Product code OVE·August 6, 2020
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·February 9, 2013
UNKNOWN DEPUY CORAIL HIP STEM
FDA Adverse Event
Injury
·DEPUY FRANCE SAS 3003895575·Product code LZO·July 23, 2014
ARTHREX
FDA Adverse Event
Malfunction
·ARTHREX INC·Product code HWC·January 3, 2011
ROI-C IMPLANT, UNKNOWN SIZE
FDA Adverse Event
Injury
·LDR MÉDICAL·Product code OVE·August 24, 2021
SPACER, UNKNOWN SIZE
FDA Adverse Event
Injury
·LDR MEDICAL·Product code ODP·August 23, 2019
ROI-C IMPLANT, UNKNOWN SIZE
FDA Adverse Event
Injury
·LDR MÉDICAL·Product code OVE·September 21, 2021
ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H6MM 14X15,5MM
FDA Adverse Event
Malfunction
·LDR MÉDICAL·Product code OVE·August 17, 2022
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015