17 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ROI-C Titanium-Coated Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
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
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
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613042462·SUPER CUT EXTENDED BLADE 5/BOX
Kerrison
FDA UDI
ELLIQUENCE, LLC·00846338005863·
DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000
FDA 510(k)
FDA Class 2
·Orthopedic
PD-100 SERIES ULTRASONIC POCKET DOPPLER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CAPSURE FIX
FDA Adverse Event
Malfunction
·MPRI·Product code NVN·June 7, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·May 8, 2018
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014