LIQUIDBAND FLOW CONTROL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

iPulse Smooth Skin Gold Hair Removal System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

Revitive Medic Plus, Revitive Advanced 2

FDA 510(k)

FDA Class 2 ·Physical Medicine

CLEARPLAN

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

PICO Single Use Negative Pressure Wound Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Axial3D Cloud Segmentation Service

FDA 510(k)

FDA Class 2 ·Radiology

Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

POLY-TAPES WITH THE FASTLOK FIXATION DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

TEMPUSIC PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

RANDOX THEOPHYLLINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Horos Mobile

FDA 510(k)

FDA Class 2 ·Radiology

Oral Device OA, Oral Device S

FDA 510(k)

FDA Class 2 ·Dental

Optilite IgG4 Kit

FDA 510(k)

FDA Class 2 ·Immunology

MODIFIED HUCKSTEP INTRAMEDULLARY NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350

FDA 510(k)

FDA Class 2 ·Physical Medicine

Braun Skin i.expert

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Pitch PaSoft Tissue Reinforcement Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE

FDA 510(k)

FDA Class 2 ·Neurology