CBC-4K HEMATOLOGY CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

NAVIO™ Surgical System (NAVIO system)

FDA 510(k)

FDA Class 2 ·Neurology

METAL URETERAL BASKET STONE DISLODGER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Chocolate PTA Balloon Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

V8 TRANSLUMINAL BAV CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

VITREA2 VERSION 3.8.1

FDA 510(k)

FDA Class 2 ·Radiology

VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CENTRAL VENOUS MULTI-LUMEN CATHETERS AND KITS

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL 8604-FO PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CareLink SmartSync Device Manager - Pacing System Analyzer

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFIED ISLAND SNAP TENS DISPOSABLE ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

Threshold Pedicular Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

3M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM

FDA 510(k)

FDA Class 2 ·General Hospital

BITX PROBES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AGILIS NXT STEERABLE INTRODUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLEAR BLUE ENDOSCOPIC LENS FOG RDUCTION SOLUTION & CLEANING KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology