HEAD SHEET

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)

FDA 510(k)

FDA Class 2 ·General Hospital

SUREcore Plus Biopsy Instrument

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ATRIUM 2050 CHEST DRAIN BLOOD RECOVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

BIO*NEPHROSS I.Q. ANDANTE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PREPEX SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STARLIGHT PULSED DIODE ARRAY LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PILLING ESOPHAGEAL BOUGIES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Concinnity Aligners

FDA 510(k)

FDA Class 2 ·Dental

SIGNAFUSE Bioactive Bone Graft

FDA 510(k)

FDA Class 2 ·Orthopedic

PATI (Protector Against Tongue Injury)

FDA 510(k)

FDA Class 2 ·Neurology

Excipio SV Aspiration Catheter and Tubing

FDA 510(k)

FDA Class 2 ·Cardiovascular

PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

THE IMS DPAP MASK, IMS MODEL NUMBER 82000

FDA 510(k)

FDA Class 2 ·Anesthesiology

MINI-OP ATS BLOOD RECOVERY BAG, MODEL 2955

FDA 510(k)

FDA Class 2 ·Anesthesiology

PALOMAR LUXIR HANDPIECE

FDA 510(k)

FDA Class 2 ·Physical Medicine

ATRIUM'S HYBRID PTFE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATS Y ADAPTER CODE #2452

FDA 510(k)

FDA Class 2 ·Anesthesiology

PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)

FDA 510(k)

FDA Class 2 ·Cardiovascular