Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AARIS AND AARIS WITH ADAPTIV OPTICS INTRAOCULAR LENS

Ablation Catheter, Renal Denervation

FDA Pre-Market Approval

FDA Class 3 ·Paradise Ultrasound Renal Denervation System, Paradise Generator

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·DUROLOANE

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTALINK EXCHANGEABLE CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·PROLIEVE THERMODILATATION SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·THERMATRX OFFICE THERMOTHERAPY SYSTEM

Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

FDA Pre-Market Approval

FDA Class 3 ·UROLUME URETHRAL STENT

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 ARTIFICIAL URINARY SPHINCTER

Implanted Fecal Incontinence Device

FDA Pre-Market Approval

FDA Class 3 ·ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·VITAGEL SURGICAL HEMOSTAT

Femtosecond Laser System For Refractive Correction

FDA Pre-Market Approval

FDA Class 3 ·VisuMax Femtosecond Laser

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CT LUCIA 202 IOL and CT LUCIA 602 IOL

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·Vysis ALK Break Apart FISH Probe Kit

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·Vysis ALK Break Apart FISH Probe Kit

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT.

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·Vysis ALK Break Apart Fish Probe Kit

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT