TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410

FDA 510(k)

FDA Class 2 ·Immunology

VSP SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

IMPLANT DRIVERS AND TIPS

FDA 510(k)

FDA Class 2 ·Dental

tmCMF Solution

FDA 510(k)

FDA Class 2 ·Dental

HUMAN IGD KIT FOR USE ON SPAPLUS

FDA 510(k)

FDA Class 2 ·Immunology

SURGICAL CUTTING BURS

FDA 510(k)

FDA Class 2 ·Dental

HUMAN IGD IMMUNOLOGICAL NL TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

coDiagnostiX

FDA 510(k)

FDA Class 2 ·Dental

CenterMed Patient Matched Assisted Surgical Planning (ASP) System

FDA 510(k)

FDA Class 2 ·Dental

VSP System

FDA 510(k)

FDA Class 2 ·Dental

LAS-R HUMAN IGD TEST

FDA 510(k)

FDA Class 2 ·Immunology

SURGICAL WIRE DRIVER

FDA 510(k)

FDA Class 2 ·Dental

AU/NZ SKREEN, Cutoff +50%, 20mL

Device

EU IVDD · Eu Ivd General ·Biochemical Diagnostics, Inc·On the market·32 countries

AU/NZ SKREEN, Cutoff -50%, 5mL

Device

EU IVDD · Eu Ivd General ·Biochemical Diagnostics, Inc·On the market·32 countries

AU/NZ SKREEN, Cutoff +50%, 5mL

Device

EU IVDD · Eu Ivd General ·Biochemical Diagnostics, Inc·On the market·32 countries

AU/NZ SKREEN, Cutoff -50%, 20mL

Device

EU IVDD · Eu Ivd General ·Biochemical Diagnostics, Inc·On the market·32 countries

Dental delivery units

Device

EU MDR · Eu Md Class 1 ·Kunshan NSJ Medical Equipment Co., Ltd.·On the market·28 countries

Hailie Sensor - for use only with HandiHaler

FDA UDI

ADHERIUM (NZ) LIMITED·09421032180330·Inhaler dose sensor

Hailie Sensor - for use only with ProAir HFA

FDA UDI

ADHERIUM (NZ) LIMITED·09421032180163·Rechargeable battery

Hailie Sensor - for use only with Advair HFA

FDA UDI

ADHERIUM (NZ) LIMITED·09421032180095·Rechargeable battery