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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SAULFON PW-70 A&B

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SOFLOW PW (LIDOFILCON B)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SAULFON PW-70 A&B

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Algovita Spinal Cord Stimulation System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Adapta, Versa, Sensia IPG, Relia IPG

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval
FDA Class 3 ·t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval
FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Zoll R Series

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SAUFLON(R) PW (LIDOFILCON B)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SAUFLON(R) PW (LIDOFILCON B)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SAUFLON(R) PW (LIDOFILCON B)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SAUFLON(R) PW (LIDOFILCON B)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SAUFLON(R) PW (LIDOFILCON B)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SAUFLON(R) PW (LIDOFILCON B)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SAUFLON(R) PW (LIDOFILCON B)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SAUFLON(R) PW (LIDOFILCON B)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SAUFLON(R) PW (LIDOFILCON B)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SAUFLON(R) PW (LIDOFILCON B)