PICC (CT RATED AND NON-RATED)

FDA 510(k)

FDA Class 2 ·General Hospital

ASEPT PERITONEAL DRAINAGE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Asept Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

primeMidline Catheters

FDA 510(k)

FDA Class 2 ·General Hospital

SAFETY BIOPSY NEEDLE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO EZ HUBER SAFETY INFUSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

NuCath Wedge Pressure Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DRAPES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ISOLATION GOWNS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Creavo Vitalscan Magnetocardiograph

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

REDON SET

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

JETCAN HUBER NEEEDLE SET

FDA 510(k)

FDA Class 2 ·General Hospital

MULTI-SNARE SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pump In Style Advanced, Advanced Personal Double Breastpump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SOL-GUARD Safety Pull Button Collection Set

FDA 510(k)

FDA Class 2 ·Clinical Chemistry