32 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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NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD (XLTEK)
Manufacturer
🇨🇦 Canada·4 Importers
HANSAmed Limited DBA Citagenix
FDA registration
HANSAmed Limited DBA Citagenix·18 products·🇨🇦 Canada
Digital Dental Laboratories, DBA Orthodent
FDA registration
Digital Dental Laboratories, DBA Orthodent·9 products·🇨🇦 Canada
DECTRONIQUE (1984) INC. DBA DECTRO INTERNATIONAL
FDA registration
DECTRONIQUE (1984) INC. DBA DECTRO INTERNATIONAL·3 products·🇨🇦 Canada
EPM GLOBAL SERVICES INC., DBA VEXOS
FDA registration
EPM GLOBAL SERVICES INC., DBA VEXOS·2 products·🇨🇦 Canada
CANADIAN SCIENTIFIC PRODUCTS LTD. DBA CSP MEDICAL
FDA registration
CANADIAN SCIENTIFIC PRODUCTS LTD. DBA CSP MEDICAL·1 product·🇨🇦 Canada
DERMA SCIENCES CANADA, INC (dba DERMA SCIENCES, INC.)
FDA registration
DERMA SCIENCES CANADA, INC (dba DERMA SCIENCES, INC.)·21 products·🇨🇦 Canada
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)
FDA registration
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)·20 products·🇨🇦 Canada
AG MARKETING & DEVELOPMENT GROUP INC DBA AGMD GROUP
FDA registration
AG MARKETING & DEVELOPMENT GROUP INC DBA AGMD GROUP·26 products·🇨🇦 Canada
SPINOLOGICS, INC. also DBA Spino Modulation Inc and Numalogics Inc
FDA registration
SPINOLOGICS, INC. also DBA Spino Modulation Inc and Numalogics Inc·1 product·🇨🇦 Canada
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
Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components are the central structural column and its base that hold up the computer and the tracking camera on the Sesamoid Plasty workstation. They are also designed to be disassembled such that the column can be folded onto itself for ease of transport after use. This is a retrospective recall report for a removal initiated on 17 June 2008
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·June 14, 2017
NDI P7 Position Sensor, Stereotaxic Instrument
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 17, 2017
NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
FDA Enforcement
Class II
·Ongoing·Orthosoft, Inc. dba Zimmer CAS·March 9, 2022
FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
FDA Enforcement
Class II
·Ongoing·ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL·September 4, 2024
Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
FDA Enforcement
Class II
·Ongoing·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·July 30, 2025
Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/A Product Description: OBM00002 OBM DAB (Digital Acquisition Box) Component: No
FDA Enforcement
Class II
·Ongoing·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·June 18, 2025