Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·LITHOTRON ULS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ORAQUICK HCV RAPID ANTIBODY TEST

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·ICAD

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

Microscope, Automated, Image Analysis, Operator Intervention

FDA classification

FDA Class 2 ·Microscope, Automated, Image Analysis, Operator Intervention

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·DEPUY 1 AND ENDURANCE BONE CEMENTS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·BAUSCH AND LOMB HEFILCON A, B AND C HYDROPHILIC CONTACT LENSES

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM

SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BAK/PROXIMITY(TM) INTERBODY FUSION SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·R1S RAPID EXCHANGE PRE-DILATATION PTCA BALLOON CATHETER

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

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK MONORAIL

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BAUSCH & LOMB(R) RENU(R) MULTI-PURPOSE SOLUTION

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·ECONOLITH LITHOTRIPTER

Hemodialysis Tray (Not A Start/Stop Kit)

FDA classification

FDA Class 2 ·Hemodialysis Tray (Not A Start/Stop Kit)