Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM

External aesthetic restoration prosthesis

FDA registration

JING YUN PLASTIC CO., LTD.·1 product·🇹🇼 Taiwan

OPTICAL SPECTACLE

FDA registration

WING KEUNG OPTICAL MANUFACTURING LTD·1 product·🇨🇳 China

Sunglasses (Non-Prescription)

FDA registration

WING KEUNG OPTICAL MANUFACTURING LTD·1 product·🇨🇳 China

TONN

FDA registration

NOVATECH S.A.·1 product·🇫🇷 France

DUTAU NOVATECH

FDA registration

NOVATECH S.A.·1 product·🇫🇷 France

TalcAir Application System

FDA registration

NOVATECH S.A.·1 product·🇫🇷 France

cannula

FDA registration

EUROMI S.A.·1 product·🇧🇪 Belgium

TRACHEOBRONXANE™ DUMON®

FDA registration

NOVATECH S.A.·1 product·🇫🇷 France

TRACHEOBRONXANE-DUMON STENTS

FDA registration

NOVATECH S.A.·1 product·🇫🇷 France

EVA SP6

FDA registration

EUROMI S.A.·1 product·🇧🇪 Belgium

LIPOMATIC / EVAMATIC

FDA registration

EUROMI S.A.·1 product·🇧🇪 Belgium

DUTAU Forceps

FDA registration

NOVATECH S.A.·1 product·🇫🇷 France

SURVAC

FDA registration

NOVATECH S.A.·1 product·🇫🇷 France

PRIME HEALTHCARE PRODUCTS PRIVATE LIMITED

Manufacturer

🇮🇳 India

Group AKM PTY LTD

Manufacturer

🇦🇺 Australia·1 Basic UDI-DI·5 Devices

Pneumeric Inc.

Manufacturer

🇺🇸 United States·1 Basic UDI-DI·1 Device

Surni Labs

Manufacturer

🇮🇳 India

Edare

Manufacturer

🇺🇸 United States

Intermark Medical Innovations Ltd

Manufacturer

3 Basic UDI-DIs·3 Devices·3 Importers·SGS Belgium NV