Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HYDRO-THERMABLATOR(HTA) ENDOMETRIAL ABLATION SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System, Ascenda Intrathecal Catheters

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·IsoMed Infusion System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FRESHLOOK SPHERICAL, TORIC AND BIFOCAL (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR UP TO 7 DAYS/

SURELIFT PROLAPSE SYSTEM

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

DCATS

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

LITE PELVIC FLOOR REPAIR KITS

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

ASCEND

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

FLEXT-THERM

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

ORTHO-THERM INFRARED SENSOR

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

NOVATHERM

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

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

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

PELVIC FLOOR REPAIR SYSTEM

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

FMS MODEL 110

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology