OFF - BEUDAMED

Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content.

FDA Enforcement

Class II ·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·June 9, 2021

Trexo Device

FDA Enforcement

Class II ·Ongoing·Trexo Robotics Holdings Inc.·August 2, 2023

Prollenium Medical Technologies Inc.

Manufacturer

🇨🇦 Canada·32 Basic UDI-DIs·32 Devices·1 Importer·NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, and NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY

Delfi Medical Innovations Inc.

Manufacturer

🇨🇦 Canada·20 Basic UDI-DIs·30 Devices·2 Importers·National Standards Authority of Ireland (NSAI)

Gamma Centre of Excellence

FDA registration

Gamma Centre of Excellence·10 products·🇨🇦 Canada

NOVOCOL PHARMACEUTICAL OF CANADA, INC.

FDA registration

NOVOCOL PHARMACEUTICAL OF CANADA, INC.·4 products·🇨🇦 Canada

ABBOTT POINT OF CARE CANADA LIMITED

FDA registration

ABBOTT POINT OF CARE CANADA LIMITED·24 products·🇨🇦 Canada

PPD MEDITECH, DIV. OF INDUSTRIES PPD INC.

FDA registration

PPD MEDITECH, DIV. OF INDUSTRIES PPD INC.·24 products·🇨🇦 Canada

Unitron Hearing, a division of National Hearing Services Inc.

FDA registration

Unitron Hearing, a division of National Hearing Services Inc.·5 products·🇨🇦 Canada

L-D TOOL & DIE DIVISION OF MADIX ENGINEERING

FDA registration

L-D TOOL & DIE DIVISION OF MADIX ENGINEERING·4 products·🇨🇦 Canada

Haemotec, a division of Fresenius Medical Care Canada Inc.

FDA registration

Haemotec, a division of Fresenius Medical Care Canada Inc.·6 products·🇨🇦 Canada

Ludlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC)

FDA registration

Ludlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC)·18 products·🇨🇦 Canada