Mediracer NCS

FDA 510(k)

FDA Class 2 ·Neurology

PM 2002 CC PROLINE

FDA 510(k)

FDA Class 2 ·Dental

DELFIA NEONATAL THYROXINE KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RUBALEX, MODIFICATION

FDA 510(k)

FDA Class 2 ·Microbiology

Icare HOME tonometer

FDA 510(k)

FDA Class 2 ·Ophthalmic

PLANMECA PROONE

FDA 510(k)

FDA Class 2 ·Dental

AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW)

FDA 510(k)

FDA Class 2 ·Orthopedic

PROSTYLE INTRA

FDA 510(k)

FDA Class 2 ·Dental

SATLITE/PB251 PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

LASERMATIC SURGILASER MODEL 5050

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

INION CPS BSSO SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH

FDA 510(k)

FDA Class 2 ·Immunology

CAPNOMAC ULTIMA ANESTHESIA MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)

FDA 510(k)

FDA Class 2 ·Radiology

INION OTPS BIODEGRADABLE MESH PLATING SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CARESCAPE MONITOR B650

FDA 510(k)

FDA Class 2 ·Cardiovascular

CRANEX BASEX D OR CRANEX EXCEL D

FDA 510(k)

FDA Class 2 ·Dental

PANORAMIC X-RAY UNIT (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Dental