NYX GOLF VISION SYSTEM

FDA 510(k)

FDA Class 1 ·Ophthalmic

ONYX HEALTHCARE USA, INC.

FDA registration

ONYX HEALTHCARE USA, INC.·4 products·🇺🇸 United States

System, communication, powered

FDA registration

ONYX HEALTHCARE USA, INC.·1 product·🇺🇸 United States

Visuscout 100

Device

EU MDD · Eu Md Class 2a ·Optomed Oyj·On the market·32 countries

Optomed Smartscope

Device

EU MDD · Eu Md Class 2a ·Optomed Oyj·No longer on the market·32 countries

BIOHIT Celiac quick test

Device

EU IVDD · Eu Ivd General ·Biohit Oyj·On the market

BIOHIT Celiac quick test

Device

EU IVDD · Eu Ivd General ·Biohit Oyj·On the market

BIOHIT FAEX Sample System

Device

EU IVDR · Eu Ivd Class A ·Biohit Oyj·On the market

BIOHIT FAEX Sample System

Device

EU IVDR · Eu Ivd Class A ·Biohit Oyj·On the market

GP Reader NT

Device

EU IVDD · Eu Ivd General ·Biohit Oyj·No longer on the market

GP Reader NT

Device

EU IVDR · Eu Ivd Class A ·Biohit Oyj·On the market

GP Reader

Device

EU IVDD · Eu Ivd General ·Biohit Oyj·No longer on the market

GastroPanel® quick test

Device

EU IVDD · Eu Ivd General ·Biohit Oyj·No longer on the market

Quick Test Reader

Device

EU IVDD · Eu Ivd General ·Biohit Oyj·No longer on the market

VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - CONSUMABLES

Device

EU MDR · Eu Md Class 1 ·Optomed Oyj·On the market·32 countries

Optomed Aurora

Device

EU MDD · Eu Md Class 1 ·Optomed Oyj·On the market·32 countries

Optomed Smartscope

Device

EU MDD · Eu Md Class 1 ·Optomed Oyj·On the market·32 countries

Optomed Smartscope

Device

EU MDD · Eu Md Class 1 ·Optomed Oyj·On the market·32 countries

Optomed Aurora

Device

EU MDD · Eu Md Class 1 ·Optomed Oyj·On the market

Injeq IQ-Tip® Analyzer

Device

EU MDR · Eu Md Class 2a ·Injeq Oyj·No longer on the market·16 countries