R 302

FDA 510(k)

FDA Class 2 ·Radiology

HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Medispine - Spinal Needle, Glospine - Spinal Needle

FDA 510(k)

FDA Class 2 ·Anesthesiology

ACENT™ Central Venous Catheter

FDA 510(k)

FDA Class 2 ·General Hospital

INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PicoSure Workstation

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PLEUR-EVAC(R) A-8000--ADULT/PEDIATRIC CHEST DRAIN

FDA 510(k)

FDA Class 2 ·General Hospital

SCHNEIDER MAGNUM PERIPHERAL RECANALIZATION GUIDEWI

FDA 510(k)

FDA Class 2 ·Cardiovascular

ORTHOALIGN PLUS SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

PERIFIX CATHETER CONNECTOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE

FDA 510(k)

FDA Class 2 ·Dental

TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS

FDA 510(k)

FDA Class 2 ·Neurology

OnPoint Augmented Reality Spine System

FDA 510(k)

FDA Class 2 ·Neurology

KNEEALIGN SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

GEL MARK IV

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia

FDA 510(k)

FDA Class 2 ·Ophthalmic

GSI Novus

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240)

FDA 510(k)

FDA Class 2 ·Cardiovascular