ASD-BIO ANTI-STICK DEVICE

FDA 510(k)

FDA Class 2 ·General Hospital

BIO-CAL 370 HEATER/COOLER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CMV BIO-BEAD TITRATION KIT

FDA 510(k)

FDA Class 2 ·Microbiology

BIO MEDX AIR FLOTATION SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

JETi AIO Peripheral Thrombectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Bio-MEM Ti Reinforced Membrane

FDA 510(k)

FDA Class 2 ·Dental

INTERLOK BIO-MODULAR HUMERAL STEMS

FDA 510(k)

FDA Class 2 ·Orthopedic

HSV BIO-BEAD TITRATION KIT

FDA 510(k)

FDA Class 2 ·Microbiology

Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal

FDA 510(k)

FDA Class 2 ·Dental

ORTHOSORB LS

FDA 510(k)

FDA Class 2 ·Orthopedic

ORTHOSORB(R) ABSORBABLE PIN

FDA 510(k)

FDA Class 2 ·Orthopedic

ORTHOSORB RESORBABLE PINS

FDA 510(k)

FDA Class 2 ·Orthopedic

CALCIUM REAGENT SYS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B

FDA 510(k)

FDA Class 2 ·Orthopedic

Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Bio-Medicus Adult Cannulae and Introducer

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS)

FDA 510(k)

FDA Class 2 ·Dental

BIO-INTRAFIX TIBIAL SCREW AND SHEATH

FDA 510(k)

FDA Class 2 ·Orthopedic