TBW

FDA 510(k)

FDA Class 2 ·Orthopedic

AXIAL COMPRESSION SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

EYEPORT VISION TRAINING SYSTEM

FDA 510(k)

FDA Class 1 ·Ophthalmic

LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

UNIWEB, VERSION 5.0

FDA 510(k)

FDA Class 2 ·Radiology

HAKOMED ELECDT/VACUPULLS

FDA 510(k)

FDA Class 2 ·Physical Medicine

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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF ICD, MRI ICD, S DR ICD, S VR ICD, XT DR ICD, XT VR ICD - Visia AF MRI DFI ICD, AF MRI VR ICD, AF VR ICD

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Evia HF /HF-T; Entovis HF/ HF-T ; Edora 8 HF-T; Entira 8 HF-1; Etrinsa 8 HF-T; Epyra 8 HF-T; Eluna 8 HF-T; Edora 8HF-T Q

BYTECH

FDA 510(k)

FDA Class 1 ·General Hospital