MICRO HAEMATOCRIT CENTRIFUGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Diode laser hair removal device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PARA CHECK (AKA EIGHT CHECK-C)

FDA 510(k)

FDA Class 2 ·Hematology

BEAMVIEW & BEAMVIEW PLUS (AKA PROJECT 743)

FDA 510(k)

FDA Class 2 ·Radiology

CANDELA SCLERO LONG PULSE LASER (AKA VBEAM)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MAXFRAME Multi-Axial Correction System (aka MAXFRAME)

FDA 510(k)

FDA Class 2 ·Orthopedic

Inspire ICE aka Inspire ICE Clear Brackets

FDA 510(k)

FDA Class 2 ·Dental

BK-A; BK-B; BK-IS SEALING CAP

FDA 510(k)

FDA Class 2 ·Cardiovascular

Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IPL Hair Removal Device (BE965A, BE965B, BE965C)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IPL Hair Removal Device (BE932C, BE932D, BE932E)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)

FDA 510(k)

FDA Class 2 ·Anesthesiology

COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT

FDA 510(k)

FDA Class 2 ·Orthopedic

Models 2200DR and 1600DR Digital Stationary Radiographic Systems

FDA 510(k)

FDA Class 2 ·Radiology

SMPLE PLATE AND SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BIOMET FORERUNNER LOCKING PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MAC MALE ADAPTER

FDA 510(k)

FDA Class 2 ·Orthopedic

BIOMET GRAFT DELIVERY SYRINGES

FDA 510(k)

FDA Class 2 ·General Hospital

MYKRES SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic