SMARTDent

FDA 510(k)

FDA Class 2 ·Radiology

RAPITEX(R) RF NEW

FDA 510(k)

FDA Class 2 ·Immunology

3I LOCATER ABUTMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

KIRSCHNER C-2 OSTEOCAP TOTAL HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

NA LATEX MYOGLOBIN TEST

FDA 510(k)

FDA Class 2 ·Immunology

N PROTEIN STANDARD PLASMA (HUMAN)

FDA 510(k)

FDA Class 2 ·Immunology

Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENZYGNOST(R) TAT REAGENTS

FDA 510(k)

FDA Class 2 ·Hematology

ENZYGNOST ANTI-CMV IGM TEST

FDA 510(k)

FDA Class 2 ·Microbiology

Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ISOTRAK AMYLASE TEST AMYLASE ISOENZYME

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ENZYGNOST ANTI-CMV/IGG + IGM

FDA 510(k)

FDA Class 2 ·Microbiology

TURBIQUANT MYOGLOBIN

FDA 510(k)

FDA Class 2 ·Immunology

ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RadialSeal Introducer Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

TURBIQUANT IMMUNOGLOBULIN & ALBUMIN KIT

FDA 510(k)

FDA Class 2 ·Immunology

AFT-HEP SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

RAYDENT SW

FDA 510(k)

FDA Class 2 ·Dental

BERICHROM ALPHA-2-ANTIPLASMIN

FDA 510(k)

FDA Class 2 ·Hematology

BERICHROM PROTEIN C KIT

FDA 510(k)

FDA Class 2 ·Hematology