Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·O2 OPTIX (LOTRAFILCON B) AND NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL, LEAD MODELS 3080, 3886, 3889, 3092, 3093, 3966, AND 3095

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·Carbomedics Prosthetic Heart Valve, Carbomedics Supra-Annular Prosthetic Heart Valve (Top Hat), Carbo-Seal Ascending Aor

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BreathTek UBT for H.pylori Kit (BreathTek UBT Kit), Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity XR Toric and Biofinity Toric Multifocal (comfilcon A) Soft (HydrophlHc) Contact Lenses for Extended Wear

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biomedics 55 Asphere (ocufilcon D), Biomedics Torie (ocufilcon D) Soft (Hydrophilic) Contact Lenses for extended wear

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PALMAZ-SCHATZ MINICROWN BALLOON-EXPANDABLE STENT WITH HEPACOAT OVER THE WIRE DELIVERY SYSTEM FOR CORONARY ARTERIES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Programmer Recorder Monitor (PRM) for Implantable Pulse Generators, Model 3300 LATITUDE Programming System, Model 6395 I

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

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

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER

DJP UNIPOLAR

FDA 510(k)

FDA Class 3 ·Cardiovascular

EKG TRANSMITTER MODEL 5134

FDA 510(k)

FDA Class 3 ·Cardiovascular

HEARTSTART 1000S

FDA 510(k)

FDA Class 3 ·Cardiovascular

LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP

FDA 510(k)

FDA Class 3 ·Cardiovascular

EDP-20 PACEMAKER

FDA 510(k)

FDA Class 3 ·Cardiovascular

AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP

FDA 510(k)

FDA Class 3 ·Cardiovascular

DJ UNIPOLAR

FDA 510(k)

FDA Class 3 ·Cardiovascular