POLYCHACO FIA-ABS TEST FOR SYPHILIS

FDA 510(k)

FDA Class 2 ·Microbiology

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

BIO-APATITE 6140 HA PARTICLES

FDA 510(k)

FDA Class 2 ·Dental

BIO-INTERFACES, INC,. BII-PLAST

FDA 510(k)

FDA Class 2 ·Dental

B1018 POROUS HA BII-PORE

FDA 510(k)

FDA Class 2 ·Dental

710 POROUS HA PARTICLES-BII-PORE

FDA 510(k)

FDA Class 2 ·Dental

BII-PORE(TM) CANAL WALL PROSTHESIS

FDA 510(k)

FDA Class 2 ·Dental

BIO-INTERFACES 1840 POROUS HA PARTICLES-BII-PORE

FDA 510(k)

FDA Class 2 ·Dental

BON APATITE HA PARTICLES

FDA 510(k)

FDA Class 2 ·Dental

BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BLL-GRAFT

FDA 510(k)

FDA Class 2 ·Dental

4060 POROUS HA PARTICULES BII PORE

FDA 510(k)

FDA Class 2 ·Dental

BII-PORE

FDA 510(k)

FDA Class 2 ·Dental

BLL-FIL 6140 PARTICLES

FDA 510(k)

FDA Class 2 ·Dental

BII-PLAST

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

swiftPro™ System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery