TROJAN-ENZ LUBRI. CONDOMS (MODIFIED LABELING)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

TROJAN-ENZ LATEX CONDOMS W/SPERMICIDAL MODIFIED

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VIDEO SCOPE SYSTEM (LARYNGOSCOPE)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DUALUME LARYNGEAL EXAMINATION TELESCOPE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

RIGID TELESCOPES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SnapshotNIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

APNEA RISK EVALUATION SYSTEM (ARES)

FDA 510(k)

FDA Class 2 ·Anesthesiology

BASIC AND DOMINANT FLEX SUCTION PUMPS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

X4 SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

TITLE 2 POLYAXIAL SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

iLet® Dosing Decision Software

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARDIS INTERBODY SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

NAVIGATOR APPLICATIONS SUITE

FDA 510(k)

FDA Class 2 ·Anesthesiology

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

SecurAcath

FDA 510(k)

FDA Class 2 ·General Hospital

Exactech Alteon Modular Dual Mobility (MDM) System

FDA 510(k)

FDA Class 2 ·Orthopedic

NIGHT SHIFT

FDA 510(k)

FDA Class 2 ·Dental

GE DATEX-OHMEDA AVANCE

FDA 510(k)

FDA Class 2 ·Anesthesiology