Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST, GEM, GEM II, GEM III, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, ONYX, PROTECTA DF4, PROTECTA, PROTECTA XT DF4,

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·JEWEL AF, GEM III AT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO, RIGHT VENTRICULAR LEAD INTEGRITY ALERT, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC UCD, INSYNC II MARQUIS, INSY

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella RP Flex with SmartAssist

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ELITE, ELITE II, MINUET, PREVA, PREVA D, PRODIGY, SYNERGYST II, THERA, THERA-I, VITATRON LEGACY, VITATRON LEGACY II

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACTIVITRAX,ACTIVITRAX II,ACTIVITRAX E,LEGEND,LEGEND II,MICRO MINIX,MINIX ST,PREMIER,PREVAIL,VITATRON LEGACY

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, ADVISA, AT500, ENPULSE, ENRHYTHM, KAPPA 600, KAPPA 650, KAPPA 700, KAPPA 800, KAPPA 900, RELIA, SENSIA, SIGMA,

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Visi

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 800, KAPPA 900, KAPPA 650, KAPPA 700, KAPPA800, KAPPA 900, RELIA, SENSIA, SIGMA, VERSA JEWEL AF GEM III AT

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·LOTRAFILCON A & B SOFT CONTACT LENSES

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO, RIGHT VENTRICULAR LEAD INTEGRITY ALERT, CONCERTO-II CRT-D, CONSULTA CRT-D, INSYNC ICD, INSYNC II MARQUIS, INSY

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·VASCADE VASCULAR CLOSURE SYSTEM

Agent, Occluding, Vascular, Permanent

FDA Pre-Market Approval

FDA Class 3 ·VenaSeal Closure System

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Gelfoam Sterile Sponge

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DIVA FAMILY INCLUDES DIAMOND II, RUBY II, TOPAZ II, JADE 11, VITA DDDR, VITA DDD AND VITA VVIR

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT

Drug-Eluting Sinus Stent

FDA Pre-Market Approval

FDA Class 3 ·PROPEL Contour SInus Implant

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval

FDA Class 3 ·LungFit PH

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody