BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

POINT SETTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ADAPT OPEN ACCESS PORT, MODEL 41233

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MILLAR/GALANTE PRECOATED TOTAL KNEE

FDA 510(k)

FDA Class 2 ·Orthopedic

BIAS(TM) FIBER METAL TOTAL HIP STEM (TFB)

FDA 510(k)

FDA Class 2 ·Orthopedic

DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic

MG II POROUS KNEE SYSTEM FEMORAL COMPONENTS

FDA 510(k)

FDA Class 2 ·Orthopedic

LEICA MODEL FL800

FDA 510(k)

FDA Class 2 ·Radiology

TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

INSALL/BURSTEIN(TM)* II TIBIAL WEDGES

FDA 510(k)

FDA Class 2 ·Orthopedic

LERMAN & SON CRANIAL ORTHOSIS HELMET

FDA 510(k)

FDA Class 2 ·Neurology

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