Diafil & Diafil Capsule

FDA 510(k)

FDA Class 2 ·Dental

DiaTemp Flow

FDA 510(k)

FDA Class 2 ·Dental

BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

RADIOPAQUE BONE CEMENT

FDA 510(k)

FDA Class 2 ·Orthopedic

AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

MIDAS REX III MOTOR

FDA 510(k)

FDA Class 2 ·Neurology

KOMET XK-95 PERFORATOR MOTOR (MI-102)

FDA 510(k)

FDA Class 2 ·Neurology

SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY

FDA 510(k)

FDA Class 2 ·Neurology

SODEM PERFORATOR DRIVE

FDA 510(k)

FDA Class 2 ·Neurology

ANSPAHC SPEED REDUCER

FDA 510(k)

FDA Class 2 ·Neurology

MICROMEDICS SURGICAL DRILL SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

LEGEND POWER ADAPTER MODEL: 6475000

FDA 510(k)

FDA Class 2 ·Neurology

STRYKER MAESTRO SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700

FDA 510(k)

FDA Class 2 ·Neurology

MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE

FDA 510(k)

FDA Class 2 ·Neurology

TRITON HUDSON CHUCK ATTACHMENT

FDA 510(k)

FDA Class 2 ·Neurology

ELAN 4 Air Motor System

FDA 510(k)

FDA Class 2 ·Neurology

CRANIAL DRILL

FDA 510(k)

FDA Class 2 ·Neurology

MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS)

FDA 510(k)

FDA Class 2 ·Neurology

MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology