4,029 results · 22ms · Sources: EU EUDAMED, US FDA

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-HER 2INEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Biologic Material, Dental

FDA Pre-Market Approval
FDA Class 3 ·STRAUMANN EMDOGAIN(R)

Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

FDA Pre-Market Approval
FDA Class 3 ·AFP MID-PREGNANCY REFERENCE PREPARATION

TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS/TRANSVENOUS, PERMANENT SCREW-IN PACING LEADS

FDA 510(k)
FDA Class 3 ·Cardiovascular

MODEL 2188 CORONARY SINUS LEAD.

FDA 510(k)
FDA Class 3 ·Cardiovascular

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval
FDA Class 3 ·KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval
FDA Class 3 ·CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval
FDA Class 3 ·KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval
FDA Class 3 ·KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval
FDA Class 3 ·KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval
FDA Class 3 ·KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval
FDA Class 3 ·KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval
FDA Class 3 ·KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval
FDA Class 3 ·KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval
FDA Class 3 ·KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval
FDA Class 3 ·KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·IntellaNav MiFi XP amd IntellaNav XP

Ligaments And Tendons, Synthetic

FDA Pre-Market Approval
FDA Class 3 ·KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Guardian Sensor (3) System