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

DESS Dental Smart Solutions

FDA 510(k)

FDA Class 2 ·Dental

elysion-pro

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

FDA 510(k)

FDA Class 2 ·Radiology

ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.

FDA 510(k)

FDA Class 2 ·Cardiovascular

INION OTPS BIODEGRADABLE MESH PLATING SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

NemoScan

FDA 510(k)

FDA Class 2 ·Radiology

QUANTIA IGE

FDA 510(k)

FDA Class 2 ·Immunology

CARESCAPE MONITOR B650

FDA 510(k)

FDA Class 2 ·Cardiovascular

CORE 3D ABUTMENT SYSTEM FOR DIGITAL PROSTHETIC SOLUTIONS

FDA 510(k)

FDA Class 2 ·Dental

microINR System

FDA 510(k)

FDA Class 2 ·Hematology

MONITRODE

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

DESS Dental Smart Solutions

FDA 510(k)

FDA Class 2 ·Dental

PICIS CHART+

FDA 510(k)

FDA Class 2 ·Cardiovascular

microINR System

FDA 510(k)

FDA Class 2 ·Hematology

PLLA PIN

FDA 510(k)

FDA Class 2 ·Orthopedic

ELEKTA OY

FDA 510(k)

FDA Class 2 ·Neurology