Medical Thulium Fiber Laser Systems (UroFiber 60Q)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CELFIRM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Powersculp laser lipolysis system

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Powersculp laser lipolysis system

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SILKPRO laser hair removal system

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Orthodontic Screw

FDA 510(k)

FDA Class 2 ·Dental

Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Diode Laser Hair Removal

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TitanPico Laser Workstation (PICO-450)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

F88 URE-SD/RD Flexible Ureteroscope

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EMS Neck Massager

FDA 510(k)

FDA Class 2 ·Physical Medicine

BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)

FDA 510(k)

FDA Class 2 ·Neurology

DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA

FDA 510(k)

FDA Class 2 ·Immunology

ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads

FDA 510(k)

FDA Class 2 ·Orthopedic

ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35

FDA 510(k)

FDA Class 2 ·Immunology

AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology