Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·USE OF RED PLASTIC PLUG WITH CONCEPT -1 SOLUTION

Contrast Media, Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·QDOT MICRO Uni-Directional Navigation Catheter, QDOT MICRO Bi-Directional Navigation Catheter

FDA Pre-Market Approval

CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IOLAB BRAND MODEL U85J UVBLOC PLUS (LC) UV-ABSORBING ONE-PIECE FLEXIBLE AC IOLS

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·COLLASTAT MICROFIBRILLAR HEMOSTATIC SPONGE

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IOLAB BRAND MODEL 2192 KELMAN UVBLOC PLUS (LC) UV-ABSORBING PMMA AC IOLS

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·CLARION MULTI-STRATEGY COCHLEAR IMPLANT(ADULT)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IOLAB BRAND UVBLOC PLUS(LC) UV-ABSORBING PMMA PC IOL'S

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·B.BRAUN,S HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P) SYSTEM

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·Sientra OPUS Silicone Gel Breast Implants

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·COLLACOTE(R),COLLATAPE(R),COLLAPLUG(R), DRESSINGS

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·HELISTAT (R) ABSORBABLE COLLAGEN HEMOSTATIC AGENT

AUTOMIX COMPOUNDER Y - ADAPTOR SET

FDA 510(k)

FDA Class 2 ·General Hospital

AUTOMIX COMPOUNDER VENTED SPIKE ADAPTOR

FDA 510(k)

FDA Class 2 ·General Hospital

DUAL COMPARTMENT TPN BAG 3 LITER

FDA 510(k)

FDA Class 2 ·General Hospital

Prosthesis, Finger, Constrained, Metal/Polymer

FDA Pre-Market Approval

FDA Class 3 ·BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS

System, Laser, Fiber Optic, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·OPTIGUIDE (TM) CYLINDRICAL FIBER OPTIC

FDA Pre-Market Approval

BOSTON SCIENTIFIC/SCIMED RADIUS CORONARY STENT

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM