BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BIPOLAR HIP DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

Aristotle Colossus Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE

FDA 510(k)

FDA Class 2 ·Orthopedic

ANATOMIC TOTAL HIP

FDA 510(k)

FDA Class 2 ·Orthopedic

Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

FEMOROTIBIAL MEDULLARY NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

MILLER/GALANTE TOTAL KNEE POR COATED PATELLAR DOME

FDA 510(k)

FDA Class 2 ·Orthopedic

DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)

FDA 510(k)

FDA Class 2 ·Radiology

INSALL/BURSTEIN* II MODULAR TOTAL KNEE

FDA 510(k)

FDA Class 2 ·Orthopedic

Plexus

FDA 510(k)

FDA Class 2 ·Cardiovascular

Magic Clear Aligners

FDA 510(k)

FDA Class 2 ·Dental

MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ

FDA 510(k)

FDA Class 2 ·Radiology

FENLIN II SHOULDER PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

EDWARDS SACRAL SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

Plato 17 Microcatheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Surgical Face Masks

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BI-ARTICULAR II HIP DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

extriCARE 1000 Negative Pressure Wound Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WORLDS BEST AND WORLDS BEST EXTRA SERIES (CONDOMS)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology