27 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Canada
×
Workstation, G2, Configured (P/N 000-0241)
FDA Enforcement
Class II
·Terminated·Intellijoint Surgical, Inc.·August 14, 2019
NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
FDA Enforcement
Class II
·Ongoing·Orthosoft, Inc. dba Zimmer CAS·March 9, 2022
Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a reference to a rigid anatomical structure can be identified.
FDA Enforcement
Class II
·Terminated·Intellijoint Surgical, Inc.·April 1, 2020
IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems.
FDA Enforcement
Class II
·Terminated·Innovative Magnetic Resonance Imaging Systems Inc.·November 28, 2012
SHIN ARCH SECTION, SIZE SMALL
Device
EU MDR
·
Eu Md Class 1
·Turbomed Orthotics inc.·On the market·26 countries
SHIN ARCH SECTION, SIZE MEDIUM
Device
EU MDR
·
Eu Md Class 1
·Turbomed Orthotics inc.·On the market·26 countries
DORSIFLEX SPRING FRONTIER SMALL (MONOCORE)
Device
EU MDR
·
Eu Md Class 1
·Turbomed Orthotics inc.·On the market·26 countries
DORSIFLEX SPRING FRONTIER MEDIUM (MONOCORE)
Device
EU MDR
·
Eu Md Class 1
·Turbomed Orthotics inc.·On the market·26 countries
CALF SECTION SIZE MED.LARGE (PRESS. SCREW)
Device
EU MDR
·
Eu Md Class 1
·Turbomed Orthotics inc.·On the market·26 countries
DORSIFLEX SPRING FRONTIER LARGE (MONOCORE)
Device
EU MDR
·
Eu Md Class 1
·Turbomed Orthotics inc.·On the market·26 countries
CALF SECTION SIZE SMALL (PRESS. SCREW)
Device
EU MDR
·
Eu Md Class 1
·Turbomed Orthotics inc.·On the market·26 countries
CARBON FIBER RODS 250 L. SMALL
Device
EU MDR
·
Eu Md Class 1
·Turbomed Orthotics inc.·On the market·26 countries
CARBON FIBER RODS 300 L. MEDIUM LARGE
Device
EU MDR
·
Eu Md Class 1
·Turbomed Orthotics inc.·On the market·26 countries
DUAL RODS 250 L. SMALL
Device
EU MDR
·
Eu Md Class 1
·Turbomed Orthotics inc.·On the market·26 countries
DUAL RODS 300 L. MEDIUM LARGE
Device
EU MDR
·
Eu Md Class 1
·Turbomed Orthotics inc.·On the market·26 countries
MAIN SECTION «Y» SIZE MEDIUM (MONOCORE)
Device
EU MDR
·
Eu Md Class 1
·Turbomed Orthotics inc.·On the market·26 countries
MAIN SECTION «Y» SIZE SMALL (MONOCORE)
Device
EU MDR
·
Eu Md Class 1
·Turbomed Orthotics inc.·On the market·26 countries
FRONT «U» SIZE SMALL (PRESS. SCREW)
Device
EU MDR
·
Eu Md Class 1
·Turbomed Orthotics inc.·On the market·26 countries
FRONT «U» SIZE MEDIUM (PRESS. SCREW)
Device
EU MDR
·
Eu Md Class 1
·Turbomed Orthotics inc.·On the market·26 countries
FRONT «U» SIZE LARGE (PRESS. SCREW)
Device
EU MDR
·
Eu Md Class 1
·Turbomed Orthotics inc.·On the market·26 countries