MENTOR NOVASILK MESH

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

PINNACLE PELVIC FLOOR REPAIR KIT II

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

AMS APOGEE VAULT SUSPENSION SYSTEM

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH

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

EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

FDA classification

FDA Class 3 ·Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·TRANSCYTE (DERMAGRAFT-TC)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB.

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

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·Medtronic MiniMed 670G System