941 results · 18ms · Sources: EU EUDAMED, US FDA

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·AED 3 BLS Device

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval
FDA Class 3 ·RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD)

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval
FDA Class 3 ·RxSight Light Adjustable Lens (LAL) and light Delivery Device (LDD)

Controller, Closed-Loop Blood Glucose

FDA Pre-Market Approval
FDA Class 3 ·BIOSTATOR GLUCOSE CONTROLLER

Controller, Closed-Loop Blood Glucose

FDA Pre-Market Approval
FDA Class 3 ·BIOSTATOR GCIIS

Electrode, Stabilized Epidural Spinal

FDA Pre-Market Approval
FDA Class 3 ·SPINAL EPIDURAL ELECTRODE FOR P.E.N.S. MODEL E-355

Controller, Closed-Loop Blood Glucose

FDA Pre-Market Approval
FDA Class 3 ·BIOSTATOR GLUCOSE CONTROLLER

Controller, Closed-Loop Blood Glucose

FDA Pre-Market Approval
FDA Class 3 ·BIOSTATOR GCIIS

Controller, Closed-Loop Blood Glucose

FDA Pre-Market Approval
FDA Class 3 ·BIOSTATOR GCIIS

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval
FDA Class 3 ·Light Adjustable Lens, Light Delivery Device

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval
FDA Class 3 ·Light Adjustable Lens and Light Delivery Device

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval
FDA Class 3 ·Light Adjustable Lens, Light Delivery Device

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval
FDA Class 3 ·RxSight Light Adjustable Lens and Light Delivery Device

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Lotrafilcon A and B Soft Contact Lenses for Extended Wear

System, Hemodynamic, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CardioMEMS HF System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·LOTRAFILCON SOFT CONTACT LENSES

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM SEVEN PLUS SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval
FDA Class 3 ·RxSight Light Adjustable Lens and Light Delivery Device