Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION CYROABLATION THERAPY SYSTEM

Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

FDA Pre-Market Approval

FDA Class 3 ·UROLUME ENDOPROSTHESES

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

FDA Pre-Market Approval

FDA Class 3 ·THERMATRX TMX-2000 BPH THERMOTHERAPY SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·THERMATRX TMX-3000 OFFICE THERMOTHERAPY SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·TMX-2000 BPH

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SELOX ST/JT STEROID-ELUTING PASSIVE-FIXATION ENDOCARDIAL PACKING LEAD MODELS SELOX ST 53, SELOX ST 60, SELOX JT 45 & 53

AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

AMER. MEDICAL OPTICS DIGITAL KERATO-

FDA 510(k)

FDA Class 3 ·Ophthalmic

APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System

AMS SPHINCTER 800 URINARY PROSTHESIS

FDA 510(k)

FDA Class 3 ·Unknown

AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

AMS ELEVATE PC

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

AMS LARGE PORE POLYPROPYLENE MESH

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

AMS PERIGEE SYSTEM

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology