Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·GENESYS HTA SYSTEM

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval

FDA Class 3 ·FETAL ACOUSTIC STIMULATOR, MODEL 0146AAY

Fluid, Hysteroscopy

FDA Pre-Market Approval

FDA Class 3 ·DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Cerene Cryotherapy Device

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·GENESYS HTA SYSTEM

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·Falope-Ring® Band and Applicator Systems

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Mara Vapor System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

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

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·COROX OTW 85 UP STEROID, LUMAX 300 DR-T, LUMAX 340 DR-T,LUMAX 300 VR-T, LUMAX 340 VR-T, LUMAX 500 DR-T,LUMAX 540 DR-T, L

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 HF-T QP, Edora 8 HF-T/QP, Evity 8 HF-T/QP,Evity 8 HF-T/QP, Corox (ProMRI) OTW 85 BP, L85 BP, S 85 BP, Sentus (Pr

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

SHARPLAN MODEL ULTRA ULTRASONIC SURG ASPIRATOR

FDA 510(k)

FDA Class 3 ·Unknown

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

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