TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge

FDA 510(k)

FDA Class 2 ·Hematology

PULPDENT CAVITY PREPARATION III

FDA 510(k)

FDA Class 2 ·Dental

HEMAGEN ENA SM KIT (EIA METHOD)

FDA 510(k)

FDA Class 2 ·Immunology

K-2 TENS OR MED TENS

FDA 510(k)

FDA Class 2 ·Neurology

ESOPHAGEAL BALLOON DILATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACTERA™ hip system

FDA 510(k)

FDA Class 2 ·Orthopedic

T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System

FDA 510(k)

FDA Class 2 ·Orthopedic

CODMAN SKULL CLAMP

FDA 510(k)

FDA Class 2 ·Neurology

SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

PRODIGY AND PRODIGY PLUS

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLEAR BRAVO

FDA 510(k)

FDA Class 2 ·Dental

A-CIFT SoloFuse

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

S.A.R.S. II (SEMI-AUTOMATIC-RECONSTITUTING-SYSTEM)

FDA 510(k)

FDA Class 2 ·General Hospital

HEMOSIL SILICA CLOTTING TIME

FDA 510(k)

FDA Class 2 ·Hematology

INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION

FDA 510(k)

FDA Class 2 ·Cardiovascular

Infinity CentralStation Wide

FDA 510(k)

FDA Class 2 ·Cardiovascular

SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

RADIONICS VARILINK 2

FDA 510(k)

FDA Class 2 ·Radiology

BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic