Access 25(OH) Vitamin D Total Calibrators For Use on the UniCel DxI Immunoassay System

Device

EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·On the market·32 countries

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT

Sunglasses

FDA registration

GLOBAL ESPRIT (SUZHOU) INC.·1 product·🇨🇳 China

ACTIVE X KNEE WRAP DOUBLE AXIS JOINT

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Camp Scandinavia AB·6 devices

ACTIVE X KNEE TUBE DOUBLE AXIS JOINT

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Camp Scandinavia AB·7 devices

Access AccuTnI+3 on UniCel DxI Calibrators

Basic UDI-DI

EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·1 device

Single Axis Free Motion Overlap Knee Joint

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Becker Orthopedic Appliance Company·6 devices

UniCel DxI Access Immunoassay System Reaction Vessels

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Beckman Coulter Inc.·1 device

Flush Solution

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Meizhou Cornley Hi-Tech Co., Ltd.·2 devices

BYTECH

FDA 510(k)

FDA Class 1 ·General Hospital

A-SERIES 4 STEP MICROSCOPE WITH AXIS SYSTEM AND COUPLER

FDA UDI

GLOBAL SURGICAL CORPORATION·00810040250224·

A-SERIES 6 STEP MICROSCOPE WITH AXIS SYSTEM AND COUPLER

FDA UDI

GLOBAL SURGICAL CORPORATION·00810040250248·

A-SERIES 3 STEP MICROSCOPE WITH AXIS SYSTEM AND COUPLER

FDA UDI

GLOBAL SURGICAL CORPORATION·00810040250200·

Access AccuTnI+3 on UniCel DxI (reagent pack)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·1 device

HEI COM. GmbH

Importer

🇦🇹 Austria

HGI Europe Oy

Importer

🇫🇮 Finland·2 Manufacturers

Footshell Runway Regular

FDA registration

OTTO BOCK HEALTHCARE CANADA·1 product·🇨🇦 Canada

Footshell Runway Regular

FDA registration

Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH·1 product·🇩🇪 Germany

Footshell Runway Regular

FDA registration

Otto Bock Healthcare Products GmbH·1 product·🇦🇹 Austria

Footshell Runway Regular

FDA registration

Ottobock Manufacturing Bulgaria EOOD·1 product·🇧🇬 Bulgaria