Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II TEMPERATURE ABLATION CATHETERS AND BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS USED WITH MAESTRO 3000 CARI

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II, BLAZER II HTD TEMPERATURE ABLATION CATHETERS, BLAZER II XP, BLAZER PRIME XP TEMPERATURE ABLATION CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II XP CARDIAC ABLATION CATHETER/CABLE/BLAZER II HIGH TORQUE DISTAL (HTD) ABLATION CATHETER/CABLE/BLAZER PRIME

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PASYS, PASYS ST, SPECTRAX S, SPECTRAX SX, SPECTRAX SX-HT, SPECTRAX SXT, SYMBIOS, SYNERGYST

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PASYS, PASYS ST, SPECTRAX S, SPECTRAX SX, SPECTRAX SX-HT, SPECTRAX SXT, SYSMBIOS, SYNERGYST

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PASYS,PASYS ST,SPECTRAX S,SPECTAX SX,SPECTRAX SX-HT,SPECTRAX SXT,SYMBIOS,SYMBIOS(AA),SYNERGYST

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFLENS (POLYMACON) CONTACT LENSES

PROFEMUR XTR HIP STEM

FDA 510(k)

FDA Class 3 ·Orthopedic

PROFEMUR TAPERED HIP STEM

FDA 510(k)

FDA Class 3 ·Orthopedic

PROFEMUR(R) E CEMENTLESS HIP STEM

FDA 510(k)

FDA Class 3 ·Orthopedic

CONSERVE PLUS QUADRAFIX ACETABULAR SHELL

FDA 510(k)

FDA Class 3 ·Orthopedic

PROFEMUR HIP SYSTEM MODULAR NECKS

FDA 510(k)

FDA Class 3 ·Orthopedic

ANTERIOR APPROACH HIP SURGERY INSTRUMENTS

FDA 510(k)

FDA Class 3 ·Orthopedic

LINEAGE HA ACETABULAR SHELLS

FDA 510(k)

FDA Class 3 ·Orthopedic

DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER

FDA 510(k)

FDA Class 3 ·Orthopedic

PROFEMUR RENAISSANCE HIP STEM

FDA 510(k)

FDA Class 3 ·Orthopedic

SATELLITE SPINAL SYSTEM

FDA 510(k)

FDA Class 3 ·Unknown

QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES

FDA 510(k)

FDA Class 3 ·Cardiovascular

CONSERVE THIN SHELL

FDA 510(k)

FDA Class 3 ·Orthopedic