232 results
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19ms
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Sources: EU EUDAMED, US FDA
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Country: Canada
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Zimmer CAS
Manufacturer
🇨🇦 Canada·1 Importer
ZIMMER CAS
FDA registration
ZIMMER CAS·24 products·🇨🇦 Canada
Coroneo Inc.
Manufacturer
🇨🇦 Canada·49 Basic UDI-DIs·49 Devices·2 Importers·GMED SAS and GMED SAS
MY01 Inc.
Manufacturer
🇨🇦 Canada·2 Basic UDI-DIs·4 Devices·1 Importer·GMED SAS
Meditech International Inc
Manufacturer
🇨🇦 Canada·18 Basic UDI-DIs·18 Devices·1 Importer·GMED SAS
bioLytical Laboratories Inc.
Manufacturer
🇨🇦 Canada·38 Basic UDI-DIs·38 Devices·Presafe Denmark A/S, Presafe Denmark A/S, Presafe Denmark A/S, Presafe Denmark A/S, and Presafe Denmark A/S
PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components.
FDA Enforcement
Class II
·Terminated·Zimmer CAS·December 10, 2014
Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;
FDA Enforcement
Class II
·Terminated·Zimmer CAS·June 10, 2015
Limbus AI Inc.
Manufacturer
🇨🇦 Canada·Kiwa Dare B.V.
SmileSonica Inc.
Manufacturer
🇨🇦 Canada·Intertek Medical Notified Body AB
Epocal Inc.
Manufacturer
🇨🇦 Canada·2 Importers·TÜV Rheinland LGA Products GmbH
Dominion Biologicals Limited
Manufacturer
🇨🇦 Canada·TÜV Rheinland LGA Products GmbH
Extra Aortic
Device
EU MDD
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Eu Md Class 3
·Coroneo Inc.·On the market·13 countries
Extra Aortic
Device
EU MDD
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Eu Md Class 3
·Coroneo Inc.·On the market·13 countries
Extra Aortic
Device
EU MDD
·
Eu Md Class 3
·Coroneo Inc.·On the market·13 countries
Extra Aortic
Device
EU MDD
·
Eu Md Class 3
·Coroneo Inc.·On the market·13 countries
Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
FDA Enforcement
Class III
·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 24, 2017
SmartTools Knee System Orthopedic Stereotaxic Instrument
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·April 26, 2017
Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 3, 2017
Navitrack System - OS Knee Universal, Stereotaxic instrument
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 24, 2017