Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

FDA classification

FDA Class 3 ·Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury

FDA classification

FDA Class 3 ·Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury

Fluorescence Imaging For Breast Cancer Detection

FDA classification

FDA Class 3 ·Fluorescence Imaging For Breast Cancer Detection

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

FDA classification

FDA Class 3 ·Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA classification

FDA Class 3 ·Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

Phakic Toric Intraocular Lens

FDA classification

FDA Class 3 ·Phakic Toric Intraocular Lens

Automated External Defibrillators (Non-Wearable)

FDA classification

FDA Class 3 ·Automated External Defibrillators (Non-Wearable)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·DEMA/DIVA IMPLANTABLE PULSE GENERATORS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM & MARQUIS FAMILY ICD'S

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ACTIVITRAX PACEMAKER FAMILY

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC JEWEL/GEM ICD'S

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC/VITATRON CARELINK PROGRAMMER

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC INSYNC (TM) BIVENTRICAL PACING SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 400 PACEMAKER FAMILY

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) CONTACT LENS MATERIAL

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC GEM ICD

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·LEGEND PLUS PACEMAKER FAMILY

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC KAPPA/SIGMA PACEMAKER FAMILIES

Electrical Impedance Spectrometer

FDA classification

FDA Class 3 ·Electrical Impedance Spectrometer

P2psa

FDA classification

FDA Class 3 ·P2psa