ICU STOPCOK WITH EXTENSION TUBING

FDA 510(k)

FDA Class 2 ·General Hospital

SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-2400

FDA 510(k)

FDA Class 2 ·Radiology

OSSEOFLEX SB

FDA 510(k)

FDA Class 2 ·Orthopedic

BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10

FDA 510(k)

FDA Class 2 ·Cardiovascular

MQL 20 ND:YAG OPHTHALMIC LASER

FDA 510(k)

FDA Class 2 ·Ophthalmic

OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Sunmed Haemostatic Valves

FDA 510(k)

FDA Class 2 ·Cardiovascular

X-Pac Expandable LLIF Cage System

FDA 510(k)

FDA Class 2 ·Orthopedic

RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIOTRACK PHENYTOIN TEST CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SYNCHRON TOTAL PROTEIN TEST --MODIFIED

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARCHON ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Panther Fusion AdV/hMPV/RV Assay

FDA 510(k)

FDA Class 2 ·Microbiology

t:slim X2 Insulin Pump with Interoperable Technology

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

Hypertension Prediction Index (HePI) Algorithm

FDA 510(k)

FDA Class 2 ·Cardiovascular

AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL

FDA 510(k)

FDA Class 2 ·Ophthalmic

KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CHEMTRAK LIQUID MULTI-ANALYTE CALIBRATOR, MUL-SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular