816 results · 22ms · Sources: EU EUDAMED, US FDA

Cross-Sectional Mammographic Xray System

FDA Pre-Market Approval
FDA Class 3 ·Koning Breast CT, KBCT (Model CBCT1000)

Femtosecond Laser System For Refractive Correction

FDA Pre-Market Approval
FDA Class 3 ·VisuMax

Femtosecond Laser System For Refractive Correction

FDA Pre-Market Approval
FDA Class 3 ·VisuMax Femtosecond Laser

Cross-Sectional Mammographic Xray System

FDA Pre-Market Approval
FDA Class 3 ·Koning Breast CT, KBCT

Femtosecond Laser System For Refractive Correction

FDA Pre-Market Approval
FDA Class 3 ·VisuMax Femtosecond Laser System

Cross-Sectional Mammographic Xray System

FDA Pre-Market Approval
FDA Class 3 ·KONING BREAST CT (MODEL CBCT 1000)

Femtosecond Laser System For Refractive Correction

FDA Pre-Market Approval
FDA Class 3 ·VisuMax Femtosecond Laser

Femtosecond Laser System For Refractive Correction

FDA Pre-Market Approval
FDA Class 3 ·VISUMAX 800

Femtosecond Laser System For Refractive Correction

FDA Pre-Market Approval
FDA Class 3 ·VisuMax Femtosecond Laser

Femtosecond Laser System For Refractive Correction

FDA Pre-Market Approval
FDA Class 3 ·VisuMax Femtosecond Laser

Femtosecond Laser System For Refractive Correction

FDA Pre-Market Approval
FDA Class 3 ·VisuMax Femtosecond Laser

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·GENESIS LINE NEUROSTIMULATION (IPG) SYSTEMS

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

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS HBSAG IMMUNOASSAY

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

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS ANTI-HBS IMMUNOASSAY

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·INSTAT COLLAGEN ABSORBABLE HEMOSTAT

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CapSure Sense Leads

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CapSureFix Novus Leads

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·TENDRIL (TENDRIL, TENDRIL ST, TENDRIL STS) AND OPTISENSE FAMILY OF LEADS