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

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

ZOLL PD 1600 SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

ONESTEP CPR II MULTI-FUNCTION ELECTRODE

FDA 510(k)

FDA Class 3 ·Cardiovascular

OMS SILICONE OIL INJECTOR

FDA 510(k)

FDA Class 3 ·Ophthalmic

ZOLL E SERIES DEFIBRILLATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

ZOLL PAD WITH CPR AID

FDA 510(k)

FDA Class 3 ·Cardiovascular

ZOLL E SERIES

FDA 510(k)

FDA Class 3 ·Cardiovascular

HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST

FDA 510(k)

FDA Class 3 ·Cardiovascular

ZOLL M SERIES ETC02 LOFLO OPTION

FDA 510(k)

FDA Class 3 ·Cardiovascular

ZOLL E SERIES WITH REAL CPR HELP

FDA 510(k)

FDA Class 3 ·Cardiovascular