Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·iStent inject Trabecular Micro-Bypass System

APPLIMED-O2 1000

Basic UDI-DI

EU MDD · Eu Md Class 2b ·HELKUEB OHG·1 device

CLEARVIEW HCG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID)

FDA 510(k)

FDA Class 1 ·Immunology

CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVANCED TREATMENT PLANNING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

TURBOX FIBRINOGEN

FDA 510(k)

FDA Class 2 ·Hematology

IMMUNOGLOBULINS G

FDA 510(k)

FDA Class 2 ·Immunology

CLEARVIEW STREP A

FDA 510(k)

FDA Class 1 ·Microbiology

TURBOX

FDA 510(k)

FDA Class 1 ·Immunology

STAPHYTECT-OD

FDA 510(k)

FDA Class 1 ·Microbiology

CLEARPLAN

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CLEARVIEW HCG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

APOLIPOPROTEIN A1

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CLEARVIEW POSITIVE AND NEGATIVE HCG URINE CONTROL SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CLEARVIEW CHLAMYDIA

FDA 510(k)

FDA Class 1 ·Microbiology

CLEARBLUE EASY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CLEARVIEW HCG SERUM/URINE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry