Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·iStent inject Trabecular Micro-Bypass System

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX EXCIMER LASER SYSTEM MODELS B AND C

Guéridon IRM 2 plateaux 2 GT

Basic UDI-DI

EU MDR · Eu Md Class 1 ·NEWMEDI·1 device

Guéridon IRM 2 plateaux 1GT 2PT

Basic UDI-DI

EU MDR · Eu Md Class 1 ·NEWMEDI·1 device

MAXCEM 2

FDA 510(k)

FDA Class 2 ·Dental

SOOTHE-N-SEAL CANKER SORE RELIEF

FDA 510(k)

FDA Class 2 ·Dental

Guéridon IRM 2 plateaux 4 PT 2GT

Basic UDI-DI

EU MDR · Eu Md Class 1 ·NEWMEDI·1 device

ROLLATOR

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Foshan Ost Medical Equipment Technology Co., LTD·1 device

Commode chair

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Foshan Ost Medical Equipment Technology Co., LTD·1 device

Electric wheelchair

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Foshan Ost Medical Equipment Technology Co., LTD·1 device

OPT SURGISYSTEMS

Importer

🇮🇹 Italy

Piccolo BioChemistry Panel Plus

FDA UDI

ABAXIS, INC.·EABA40000351·The Piccolo® BioChemistry Panel Plus, used with...

Piccolo General Chemistry 13

FDA UDI

ABAXIS, INC.·EABA40000291·The Piccolo® General Chemistry 13 used with the...

LATEX EXAMINATION GLOVE

FDA 510(k)

FDA Class 1 ·General Hospital

VAX-T PELVIC TRACTION BELT

FDA 510(k)

FDA Class 2 ·Physical Medicine

BEMCO PORTABLE OXYGEN INHALATOR

FDA 510(k)

FDA Class 1 ·Anesthesiology

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·QUICKSEAL SURESTAT ARTERIAL CLOSURE SYSTEM

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

FDA Pre-Market Approval

FDA Class 3 ·T SPOT-TB TEST

Oragene Dx

FDA UDI

DNA Genotek Inc·00627595000132·DNA Specimen Collection, Saliva

SigmaTech Nordic ApS

Authorized representative

🇩🇰 Denmark·5 Manufacturers·311 Devices