DISINTEK™ PA Test Strips

FDA 510(k)

FDA Class 2 ·General Hospital

Rapicide PA High-Level Disinfectant Test Strips

FDA 510(k)

FDA Class 2 ·General Hospital

PrisMax System Version 3

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EZ MOVER

FDA 510(k)

FDA Class 2 ·Radiology

3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LIFEGUARD BACTERIAL AND VIRAL FILTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System

FDA 510(k)

FDA Class 2 ·Orthopedic

InCore Subtalar System

FDA 510(k)

FDA Class 2 ·Orthopedic

Steerable Introducer

FDA 510(k)

FDA Class 2 ·Cardiovascular

XTREL, MODEL NUMBER 3425

FDA 510(k)

FDA Class 2 ·Neurology

SCIMED 6 FRENCH ANGIOGRAPHIC CATHETER MODIFICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

NOETIX, BIOPSY NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PORGES ENDOSCOPIC DORMIA EXTRACTORS, DORMIATRIPTOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ATRILAZE MI SURGICAL ABLATION SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACCU-CHEK (R) EASY (TM) BLOOD GLUCOSE SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CBC-LASER(R) HEMATOLOGY CONTROL/MULTIPLE-MODIFIED

FDA 510(k)

FDA Class 2 ·Hematology

K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Spectre guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

Direxion Torqueable Microcatheter

FDA 510(k)

FDA Class 2 ·Cardiovascular