Nexta PEEK Hammertoe Correction System

FDA 510(k)

FDA Class 2 ·Orthopedic

CoaguChek XS Plus System

FDA 510(k)

FDA Class 2 ·Hematology

ISE COMPENSATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COBAS INTEGRA CHLORIDE ELCTRODE GEN.2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SMR SHOULDER SYSTEM- REVISION STEMS

FDA 510(k)

FDA Class 2 ·Orthopedic

Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers

FDA 510(k)

FDA Class 2 ·Orthopedic

DEPUY (NITINO) GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Orthopedic

BIO-CORE INTERFERENCE SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7350, 6150, 6100

FDA 510(k)

FDA Class 2 ·Radiology

COOK CELECT VENA CAVA FILTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Liver Access and Biopsy Sets

FDA 510(k)

FDA Class 2 ·Cardiovascular

SILICONE FOLEY CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CORAIL AMT HIP PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

SIS HERNIA GRAFT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIVONA CARDEN INTERMITTENT JETTING DEVICE

FDA 510(k)

FDA Class 2 ·Anesthesiology

AVENIR CEMENTED HIP STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

OMNITECH FULGURATING ELECTRODE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DISTAL VOLAR RADIUS PLATING SYSTEMS

FDA 510(k)

FDA Class 2 ·Orthopedic

CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry