SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

UCP MULTI-DRUG TEST KEY CUPS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

INVIVO DENTAL

FDA 510(k)

FDA Class 2 ·Radiology

STRYKERWARE SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

BALLOON DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

InVivo Web Viewer

FDA 510(k)

FDA Class 2 ·Radiology

HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED

FDA 510(k)

FDA Class 2 ·Neurology

Tablo® Hemodialysis System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STEALTH CATHETER SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEWISSEN CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEURO CHECK DEVICE WITH IO-FLEX WIRE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VISTA ULTRASENSITIVE HTSH ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STRYKER CASSETTE PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

Rodo Abutment System

FDA 510(k)

FDA Class 2 ·Dental

A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

TARGET THERAPEUTICS RADIOPAQUE STYLET

FDA 510(k)

FDA Class 2 ·Cardiovascular

CONTOURING DEVICE

FDA 510(k)

FDA Class 2 ·Radiology

OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT); CATALOG # 0021 (5000 TESTS KIT)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN

FDA 510(k)

FDA Class 2 ·Hematology