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

TEMPUS PRO EXTENDED FEATURES

FDA 510(k)

FDA Class 2 ·Cardiovascular

GL ULTRASOUND SECTOR 170

FDA 510(k)

FDA Class 2 ·Radiology

Infinity-Lock 3, Infinity-Lock 5

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Scope ProTech

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DEPILASE TWIN LASE LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit

FDA 510(k)

FDA Class 2 ·Immunology

Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD

FDA 510(k)

FDA Class 2 ·Radiology

DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories

FDA 510(k)

FDA Class 2 ·General Hospital

DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT

FDA 510(k)

FDA Class 2 ·Immunology

SURGIDEK B

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery