System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CardioMEMS Hospital System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·APLIGRAF

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 URINARY CONTROL SYSTEM & AMS 800 URINARY CONTROL SYSTEMS WITH INHIBIZONE TREATMENT

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·ReShape Integrated Dual Ballon System

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·ORBERA Intragastric Balloon (IGB) System, Endoline Punc

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·Artegraft Collagen Vascular Graft

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·ENROUTE Transcarotid Stent System

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 INFLATABLE PENILE PROSTHESIS

ZOLL SUREPOWER SINGLE BAY CHARGER

FDA 510(k)

FDA Class 3 ·Cardiovascular

CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USE

FDA 510(k)

FDA Class 3 ·Unknown

AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

PACING LEADS MODEL 3262VU/VB, 3362VU/VB, 3380/3390

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE

FDA 510(k)

FDA Class 3 ·Cardiovascular

LITE PELVIC FLOOR REPAIR KITS

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

ZOLL M SERIES ETCO2 OPTION

FDA 510(k)

FDA Class 3 ·Cardiovascular

HEARTSTART MRX, MODELS M3535A OR M3536A

FDA 510(k)

FDA Class 3 ·Cardiovascular

STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODES

FDA 510(k)

FDA Class 3 ·Cardiovascular