UltraScore Focused Force PTA Balloon

FDA 510(k)

FDA Class 2 ·Cardiovascular

AngioSculpt PTA Scoring Baloon Catheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANGIOSCULPT PTA SCORING BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

OSTEOPOWER SYSTEM AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Dental

XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLEX Vessel Prep System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)

FDA 510(k)

FDA Class 2 ·Cardiovascular

OsteoMed PINNACLE Driver

FDA 510(k)

FDA Class 2 ·Dental

YOUNG D'GRANULATOR

FDA 510(k)

FDA Class 2 ·Dental

VASCUTRAK PTA DILATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANGIOSCULPT PTA SCORING BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLEX SCORING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Tissue Adhesive For The Topical Approximation Of Skin

FDA Pre-Market Approval

FDA Class 2 ·DERMABOND (A FORMULATION OF 2-OCTYL CYANOACRYLATE)

Tissue Adhesive For The Topical Approximation Of Skin

FDA Pre-Market Approval

FDA Class 2 ·HIGH VISCOSITY DERMABOND TOPICAL SKIN ADHESIVE

CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)

FDA 510(k)

FDA Class 2 ·Ophthalmic

NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TRUMPET VALVE W/CUTTING & COAGULATION HANS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)

FDA 510(k)

FDA Class 2 ·Ophthalmic

METROFOCAL TORIC (HIOXIFILCON A) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT

FDA 510(k)

FDA Class 2 ·Ophthalmic