Electrode, Stabilized Epidural Spinal

FDA Pre-Market Approval

FDA Class 3 ·SPINAL EPIDURAL ELECTRODE FOR P.E.N.S. MODEL E-355

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·EXPANSION OF LATHE LINES FOR INTRAOCULAR LENS MANUFACTURING

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·LOTRAFILCON A SOFT CONTACT LENSES FOR EXTENDED WEAR

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·EUCLID SYSTEMS ORTHOKERATOLOGY CONTACT LENSES FOR OVERNIGHT WEAR

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLES 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHIL

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI COOLED ABLATION SYSTEM FOR THE CIRCUCOOL PUMP

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·BD OVD 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SimplifEYE Preloaded Delivery System for enVista Intraocular Lens

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Lotrafilcon A Soft Contact Lenses for Extended Wear

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON SENOFILCON A CONTACT LENS FOR EXTENDED WEAR

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation (SNM) System for Urinary Control

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation (SNM) System for Bowel Control

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·DARDIK BIOGRAFT FOR PERIPHERAL & AV ACCESS USE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation (SNM) System for Bowel Control