Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ORIGEN, INOGEN, DYNAGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ORIGEN, INOGEN, DYNAGEN, CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D)

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NovaSure Impedance Controlled Endometrial Ablation System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CSI CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·CSI COLOURS CONTACT LENSES

Dna-Probe, Human Chromosome

FDA Pre-Market Approval

FDA Unclassified ·OSI TRANSPROBE-1

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CSI(CROFILCON A)EXTENDED WEAR SOFT

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE IS-I PASSIVE FIXATION

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CSI (CROFILCON A) EXTENDED WEAR SOFT

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·Diamondback 360 Coronary Orbital Atherectomy Device (OAD)

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·JSZ ORTHOKERATOLOGY CONTACT LENSES FOR OVERNIGHT WEAR

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·CSI (CROFILCON A) EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·VENTANA HER2 Dual ISI-I DNA Probe Cocktail

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·JSZ ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR

Kit, Identification, Neisseria Gonorrhoeae

FDA Pre-Market Approval

FDA Class 1 ·GONOSTICON DRI-DOT TEST

Manual Antimicrobial Susceptibility Test Systems

FDA Pre-Market Approval

FDA Class 2 ·UNISCEPT(TM)

Kit, Identification, Neisseria Gonorrhoeae

FDA Pre-Market Approval

FDA Class 1 ·GONOCOCCAL PILI ANTIBODY TEST

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

FDA Pre-Market Approval

FDA Class 2 ·MICROVEL(R) WITH HEMASHIELD

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

FDA Pre-Market Approval

FDA Class 2 ·HEMASHIELD(R) MICROVEL (R) DOUBLE VELOUR GRAFT