INNOFLUOR GENTAMICIN ASSAY SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320)

FDA 510(k)

FDA Class 2 ·General Hospital

Endoform Reconstructive Template - PLGA

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Endoform Dental Membrane

FDA 510(k)

FDA Class 2 ·Dental

MATRIXBRUSH ENDOMETRIAL SAMPLER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ATHENA PEDICLE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

FIREFLY® Midline Navigation Guide

FDA 510(k)

FDA Class 2 ·Orthopedic

FIREFLY® Pedicle Screw Navigation Guide

FDA 510(k)

FDA Class 2 ·Orthopedic

HELENA SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

FIREFLY® Cervical Navigation Guide

FDA 510(k)

FDA Class 2 ·Orthopedic

FIREFLY Pedicle Screw Navigation Guide

FDA 510(k)

FDA Class 2 ·Orthopedic

FIREFLY® Pedicle Screw Navigation Guide

FDA 510(k)

FDA Class 2 ·Orthopedic

ALOE CADABRA LUBRICANT, ALOE CADABRA FLAVORED/SCENTED LUBRICANTS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OAKTREE Anterior Lumbar Plate and Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

Fixxsure Anterior Lumbar Plate and Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-11

FDA 510(k)

FDA Class 2 ·Ophthalmic

Climax Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VENA CAVA FILTER SYSTEMS, MODIFICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

PERCUTANEOUS INTRODUCER FOR VENA CAVA FILTER SYST

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTERX5000

FDA 510(k)

FDA Class 2 ·Neurology