TEBCO-W

FDA 510(k)

FDA Class 2 ·Cardiovascular

NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER

FDA 510(k)

FDA Class 2 ·Dental

CUSTOM ITE HEARING AID

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

ORTHOTEC K-CAP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Motion Correction System

FDA 510(k)

FDA Class 2 ·Radiology

DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

OSTEON BONE MINERAL ANALYZER

FDA 510(k)

FDA Class 2 ·Radiology

MODIFIED OSTEOANALYZER (# SPSHA110/220)

FDA 510(k)

FDA Class 2 ·Radiology

REGEN BIOCEMENT

FDA 510(k)

FDA Class 2 ·Dental

ARASYS

FDA 510(k)

FDA Class 2 ·Physical Medicine

Homocysteine （HCY）Assay Kit (Enzymatic Cycling Method)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device

Sunglasses

FDA registration

GLOBAL ESPRIT (SUZHOU) INC.·1 product·🇨🇳 China

HANDLE

Basic UDI-DI

EU MDR · Eu Md Class 1 ·OrthoPediatrics Canada ULC·1 device

BYTECH

FDA 510(k)

FDA Class 1 ·General Hospital

HEI COM. GmbH

Importer

🇦🇹 Austria

HGI Europe Oy

Importer

🇫🇮 Finland·2 Manufacturers

Piezosurgery Flex

FDA registration

Mectron North America·5 products·🇺🇸 United States

Synergy Health Daniken AG

FDA registration

Synergy Health Daniken AG·5 products·🇨🇭 Switzerland

STERIS SPA

FDA registration

STERIS SPA·5 products·🇮🇹 Italy

PIEZOTOME M+

FDA registration

SATELEC-ACTEON GROUP·5 products·🇫🇷 France