245 results
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18ms
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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
Etymonic Design Inc. operating as Audioscan
Manufacturer
🇨🇦 Canada
Armery Medical Technologies Inc.
Manufacturer
🇨🇦 Canada
Mespere LifeSciences Inc
Manufacturer
🇨🇦 Canada·2 Basic UDI-DIs·2 Devices·2 Importers·SGS Belgium NV
Batrik Medical Manufacturing Inc.
Manufacturer
🇨🇦 Canada·131 Basic UDI-DIs·1075 Devices·5 Importers·SGS Belgium NV
NuMED Canada, Inc.
Manufacturer
🇨🇦 Canada·2 Basic UDI-DIs·2 Devices·9 Importers·SGS Belgium NV
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
Circle Cardiovascular Imaging Inc
Manufacturer
🇨🇦 Canada·6 Basic UDI-DIs·7 Devices·3 Importers·BSI Group The Netherlands B.V., SGS Belgium NV, and BSI Group The Netherlands B.V.
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
CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER
Device
EU MDD
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Eu Md Class 2a
·Batrik Medical Manufacturing Inc.·On the market·9 countries
CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER
Device
EU MDD
·
Eu Md Class 2a
·Batrik Medical Manufacturing Inc.·On the market·9 countries
CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER
Device
EU MDD
·
Eu Md Class 2a
·Batrik Medical Manufacturing Inc.·On the market·9 countries
CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER
Device
EU MDD
·
Eu Md Class 2a
·Batrik Medical Manufacturing Inc.·On the market·10 countries
CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER
Device
EU MDD
·
Eu Md Class 2a
·Batrik Medical Manufacturing Inc.·On the market·10 countries
CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER
Device
EU MDD
·
Eu Md Class 2a
·Batrik Medical Manufacturing Inc.·On the market·10 countries
StrokeSENS
Device
EU MDD
·
Eu Md Class 2a
·Circle Cardiovascular Imaging Inc·On the market·8 countries
SKIN MARKING DERMOGRAPHIC PENCILS AND PENS
Device
EU MDD
·
Eu Md Class 1
·Batrik Medical Manufacturing Inc.·On the market·4 countries
SKIN MARKING DERMOGRAPHIC PENCILS AND PENS
Device
EU MDD
·
Eu Md Class 1
·Batrik Medical Manufacturing Inc.·On the market·4 countries