Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·DEPUY 1 AND ENDURANCE BONE CEMENTS

PROMED 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FORM LENS BLANK)

FDA 510(k)

FDA Class 2 ·Ophthalmic

BENZ B36 (KOLFOCON B) RIGID GAS PERMEABLE (HYDROPHOBIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLANK)

FDA 510(k)

FDA Class 2 ·Ophthalmic

METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT FROM LEN

FDA 510(k)

FDA Class 2 ·Ophthalmic

remOVE System

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ULTRAVUE/P, ULTRALVUE/C (HIOXIFILCON B)) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & YINTED, LATHE-CUT FROM LENS)

FDA 510(k)

FDA Class 2 ·Ophthalmic

OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR)

FDA 510(k)

FDA Class 2 ·Ophthalmic

Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML)

FDA 510(k)

FDA Class 2 ·Dental

HORIZON/WESTHIN 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLAN

FDA 510(k)

FDA Class 2 ·Ophthalmic

AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK)

FDA 510(k)

FDA Class 2 ·Ophthalmic

Tissue Adhesive For The Topical Approximation Of Skin

FDA Pre-Market Approval

FDA Class 2 ·HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE

Tissue Adhesive For The Topical Approximation Of Skin

FDA Pre-Market Approval

FDA Class 2 ·INDERMIL(TM) TISSUE ADHESIVE

MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY NEEDLE MODEL MCN-

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL

FDA 510(k)

FDA Class 2 ·Ophthalmic

3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON

FDA 510(k)

FDA Class 2 ·Cardiovascular

ELECTROSURGICAL DISPERSIVE ELECTRODE AND ELECTROSURGICAL DUAL RETURN ELECTRODE WITH CONDUCTIVE GEL AND 10 FT. CORD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ELECTRO-LUBE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SWITCHBLADE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BALLARD MEDICAL PRODUCTS ELECTRO-SURG

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Apyx Plasma/RF Handpiece

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery