OFG - BEUDAMED

GOLFF Sterile Anti-Fog Solution

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LEADING EDGE MFG. INC.

FDA registration

LEADING EDGE MFG. INC.·4 products·🇨🇦 Canada

ZOLAR TECHNOLOGY & MFG CO INC

FDA registration

ZOLAR TECHNOLOGY & MFG CO INC·1 product·🇨🇦 Canada

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)

PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)

FDA Enforcement

Class II ·Ongoing·AMD Medicom Inc.·February 28, 2024

HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)

FDA Enforcement

Class II ·Ongoing·AMD Medicom Inc.·February 28, 2024