MODEL 366-23 ADAPTAID(TM) STEP-DOWN ADAPTER

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 366-27 ADAPTAID(TM) STEP-DOWN ADAPTER

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 493-08 POLYFLEX ENDOCARDIAL LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 366-12 ADAPTAID(TM) STEP-DOWN ADAPTER

FDA 510(k)

FDA Class 3 ·Cardiovascular

ELECTRODE, PACEMAKER, PERMANENT & TEMPORARY

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 366-12 ADAPTAID (TM) STEP-DOWN ADAPTER

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 366-14 INTERMEDICS LEAD CONNECTOR CAP

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 366-13 ADAPTAID STEP DOWN ADAPTER

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 439-07 AND 439-09 LIFELINE MYOCARDIAL LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

PIKOS 01 & PIKOS E 01

FDA 510(k)

FDA Class 3 ·Cardiovascular

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·TORAY SOFT CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·TORAY SOFT CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·TORAY SOFT CONTACT LENSES

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)

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