Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX LEAD,CAPSUREFIX NOVUS LEAD,SUREFIX LEAD,TORQUE CLIP DEVICE - ACCESSORY FOR 5076 LEAD

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Natural Eyes HydraWear XW Extended Parameters, Natural Eyes HydraWear XW for Astigmatism Extended Parameters

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·AIR OPTIX plus HydraGlyde (lotrafilcon B) Soft Contact Lenses for Daily and Extedned Wear

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOMEDICS 55 (OCUFILCON D) UV BLOCKER IMT SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGEVITY™ MRI Leads, Slit Suture Sleeve Accessory for INGEVITY Leads (Pacing Leads and Accessories)

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·PEARL 8.0 HANDPIECE FOR TRANSMYOCARDIAL REVASCULARIZATION (TMR) WITH THE CARDIOGENESIS HOLMIUM: YAG LASER SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Orchestra/Orchestra Plus C3PR/C3PRH, Orchestra Plus Link, USB adapter for CPR3H, Smart ECG

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·H&LB ONE-SHOT DELIVERY SYSTEM FOR USE WITH THE ZENITH FLEX AAA ENDOVASCULAR GRAFT

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, TORQUE CLIP DEVICE-ACCESSORY FOR 5076 LEAD

S.A.F. ACETABULAR CUP WITH POROUS COATING

FDA 510(k)

FDA Class 3 ·Orthopedic

POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT

FDA 510(k)

FDA Class 3 ·Orthopedic

FMS MODEL 110

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

KM-3 ACETABULAR COMPONENT

FDA 510(k)

FDA Class 3 ·Orthopedic

ATH METAL:UHMWPE TOTAL HIP SYSTEM

FDA 510(k)

FDA Class 3 ·Orthopedic

POROUS-COATED TITANIUM ACETABULAR CUP

FDA 510(k)

FDA Class 3 ·Orthopedic

DIMENSION TOTAL HIP PROSTHESIS POROUS COATED

FDA 510(k)

FDA Class 3 ·Orthopedic