LeadCare Plus Blood Lead Testing System

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BIOSPONGE STAPES PISTON

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

StarPore

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

LEADCARE BLOOD LEAD TESTING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MEDPOR CUSTOMIZED SURGICAL IMPLANT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SILMAX CONTOUR CARVING BLOCK IMPLANT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ATOMSPEC GF BLOOD LEAD WORKSTATION

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LEADCARE II BLOOD LEAD TESTING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

STAT/PB REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BIOSPONGE RECONSTRUCTION DISCS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PoreStar Patient Specific Implant

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SOF FORM (DELTAFILCON A)

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SOF FORM (DELTAFILCON A)

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SOF FORM (DELTAFILCON A)

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SOF FORM CONTACT LENSE

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SOF FORM (DELTAFILCON A)

RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS

FDA 510(k)

FDA Class 2 ·Radiology

INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016

FDA 510(k)

FDA Class 2 ·Dental

External Counterpulsation System, Soulaire

FDA 510(k)

FDA Class 2 ·Cardiovascular

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOF!PRO-CLEAN CONTACT LENS CLEANER