NEOS-M PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP

FDA 510(k)

FDA Class 3 ·Cardiovascular

LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES

FDA 510(k)

FDA Class 3 ·Cardiovascular

HEART*AID 1000

FDA 510(k)

FDA Class 3 ·Cardiovascular

ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP

FDA 510(k)

FDA Class 3 ·Cardiovascular

HEARTSTART 3000

FDA 510(k)

FDA Class 3 ·Cardiovascular

RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000

FDA 510(k)

FDA Class 3 ·Cardiovascular

NEOS VS-1, PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

TRIOS-M VS-1 PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATHTEK UBT FOR H.PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM/COBAS AMPLIPREP/COBAS TAQMAN HBV TEST

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·FineLine II Sterox Leads, Fineline II Sterox EZ Leads, and Suture Sleeve Accessories for FineLine II Leads

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·AIR OPTIX plus HydraGlyde / AIR OPTIX plus HydraGlyde for Astigmatism / AIR OPTIX plus HydraGlyde Multifocal / AIR OPTIX

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/ACCESSORY (UPSIZING SLEEVE)

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·ACUVUE® AbilitiTM Overnight; ACUVUE® AbilitiTM Overnight Therapeutic Lenses For Myopia Management; Menicon Z Night (Ti

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACCESSORY (UPSIZING SLEEVE)/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/ GEM/PCD TACHY CONTROL SYSTEM/JEWEL/LEAD END PIN

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·FINELINE II Sterox Lead, FINELINE II Sterox EZ Lead abnd Suture Sleeve Accessory (for FINELINE II Leads)

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SURFIX LEAD, TORQUE CLIP DEVICE -ACCESSORY FOR 5076 LEAD, VITATRON CRYSTALLINE L