Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·PREPSTAIN INSTRUMENT

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Paradigm Real-Time System and Paradigm Real-Time Revel System

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Aesculap activL Artificial Disc

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

FDA Pre-Market Approval

FDA Class 3 ·DIASORIN ETI MAK-2 PLUS ASSAY

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Paradigm Real-Time Revel System

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENSES FOR OVERNIGHT WEAR FOR B&L VISION SHAPING TREATMENT

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ATTAIN STARFIX

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VITESSE POINT 9 MM X80 & EXTREME POINT 9MM X80 PERCUTANEOUS CORONARY ANGIOPLASTY CATHETER, MODELS 110-004 AND 110-002

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARELINK MONITOR AND EXPRESS MONITOR, CARDIOSIGHT READER; CARELINK EXPRESS

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 530G System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·RESTORESENSOR RECHARGABLE IMPLANTABLE NEUROSTIMULATION SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·EC-5000 EXCIMER LASER SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC KAPPA 900/800 SERIES PACING SYSTEM

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·C-KIT PHARMDX

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ENPULSE IMPLANTABLE PULSE GENERATOR AND MODEL 9991 APPLICATION SOFTWARE

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·MODEL 7421 ITREL(R) 7424 ITREL(R) II, 7425 ITREL(R) III AND MODEL 7427 SYNERGY(TM) IMPLANTABLE PULSE GENERATORS

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

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER2 DUAL ISH DNA PROBE COCKTAIL

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·AED Plus and Fully Automatic AED Plus