17 results · 31ms · Sources: EU EUDAMED, 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