MINIM-X 2001-CIAS & MINIM-X 2002-CIAS

FDA 510(k)

FDA Class 2 ·Dental

IBL C1Q-CIC CIA TEST

FDA 510(k)

FDA Class 2 ·Immunology

Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

EQUIDOSE SOLID STATE DIODE DETECTORS

FDA 510(k)

FDA Class 2 ·Radiology

CINtec Histology (50 tests), CINtec Histology (250 tests)

FDA 510(k)

FDA Class 2 ·Pathology

CINtec Histology

FDA 510(k)

FDA Class 2 ·Pathology

LEONI ORION System

FDA 510(k)

FDA Class 2 ·Radiology

Neodent Implant System

FDA 510(k)

FDA Class 2 ·Dental

RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SnapshotNIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

iLet® Dosing Decision Software

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

InVision™ 1.5 Surgical Theatre

FDA 510(k)

FDA Class 2 ·Radiology

EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS

FDA 510(k)

FDA Class 2 ·Orthopedic

Exactech Alteon Modular Dual Mobility (MDM) System

FDA 510(k)

FDA Class 2 ·Orthopedic

iLet® ACE Pump

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Direxion and Direxion HI-FLO Torqueable Microcatheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

HUMID-VENT HEPA

FDA 510(k)

FDA Class 2 ·Anesthesiology

Uroject12 Syringe Lever

FDA 510(k)

FDA Class 2 ·General Hospital

CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1

FDA 510(k)

FDA Class 2 ·Neurology