cobas® 4800 System Sample Preparation Kit

FDA UDI

Roche Molecular Systems, Inc.·00875197003178·

Aptima

FDA UDI

Hologic, Inc.·15420045500105·

cobas® 4800 System Wash Buffer Kit

FDA UDI

Roche Molecular Systems, Inc.·00875197003239·

Isomedix Operations, Inc.

FDA registration

Isomedix Operations, Inc.·1 product·🇺🇸 United States

Mi1000 MED-EL CONCERT PIN Cochlear Implant

FDA registration

ROSE GMBH FUER MEDIZINTECHNIK·1 product·🇩🇪 Germany

Maxum

FDA registration

Ototronix, LLC (Minnesota)·1 product·🇺🇸 United States

Vibrant Soundbridge

FDA registration

MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·1 product·🇦🇹 Austria

PORTABLE VENTILATOR, MODEL EPV-100

FDA 510(k)

FDA Class 2 ·Anesthesiology

RATE INCREASE FOR IPPB/IPV

FDA 510(k)

FDA Class 1 ·Dental

Tristel Solutions Limited

Manufacturer

34 Basic UDI-DIs·35 Devices·6 Importers·BSI Group The Netherlands B.V.

AnatoPath Limited

Manufacturer

3 Basic UDI-DIs·8 Devices

Barco, Inc.

Manufacturer

🇺🇸 United States·1 Basic UDI-DI·3 Devices·1 Importer

Barco (Suzhou) Healthcare Technology Co., Ltd.

Manufacturer

🇨🇳 China·1 Basic UDI-DI·5 Devices

IMPAX Orthopaedic Workstation

FDA registration

AGFA HEALTHCARE INC.·1 product·🇨🇦 Canada

Enterprise Imaging Desktops

FDA registration

AGFA HEALTHCARE INC.·1 product·🇨🇦 Canada

Drystar DT 2 B

FDA registration

Agfa Material Corporation·1 product·🇺🇸 United States

Enterprise Imaging Desktops

FDA registration

Agfa HealthCare·1 product·🇧🇪 Belgium

Enterprise Imaging

FDA registration

AGFA HEALTHCARE INC.·1 product·🇨🇦 Canada

MA3000

FDA registration

AGFA HEALTHCARE INC.·1 product·🇨🇦 Canada

Enterprise Imaging Desktops

FDA registration

Agfa HealthCare GmbH·1 product·🇦🇹 Austria