C.P.R. LANDMARC

FDA 510(k)

FDA Class 2 ·Cardiovascular

BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGE

FDA 510(k)

FDA Class 2 ·Anesthesiology

LEVANT, HOMEGLIDE

FDA 510(k)

FDA Class 2 ·Physical Medicine

FLOW2, SWING

FDA 510(k)

FDA Class 2 ·Physical Medicine

APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI)

FDA 510(k)

FDA Class 2 ·Orthopedic

RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES

FDA 510(k)

FDA Class 2 ·Ophthalmic

Disposable Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·VIS-SOL STERILE PRESERVED SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ISOTONIC STERILE UNPRESERVED SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·VIS-SOL STERILE PRESERVED SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ISOTONIC STERILE UNPRESERVED SALINE SOLUTION

NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ANAZYME ANA PEROXIDASE TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

IP SPECIFIC G

FDA 510(k)

FDA Class 2 ·Immunology

ANA MICROZYME TEST SYS #1610

FDA 510(k)

FDA Class 2 ·Immunology

ANTINUCLEAR ANTIBODY TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL

FDA 510(k)

FDA Class 2 ·Immunology

Suture, Absorbable, Synthetic

FDA Pre-Market Approval

FDA Class 2 ·VICROL SYNTHETIC ABSORABLE SUTURE UNDYED

Suture, Absorbable, Synthetic

FDA Pre-Market Approval

FDA Class 2 ·VICRYL (POLYGLACTIN 910) SUTURE