232 results · 19ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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 · 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

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