327 results · 20ms · Sources: EU EUDAMED, US FDA

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·STELID II BTF/BJF STEROID COLLAR

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·STELID II BTF/BJF - STELIX II BRF

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·ORIGEN / INOGEN / DYNAGEN / AUTOGEN / MOMENTUM / VIGILANT / RESONATE / Implantable Cardiac Resynchronization Therapy Def

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic Def

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval
FDA Class 3 ·BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WAVELIGHT EX500 LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WAVELIGHT EX500 LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WAVELIGHT ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·ALLEGRETTO WAVE EYE-Q LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WAVELIGHT ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WAVELIGHT EX500 EXCIMER LASER SYSTEM, ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·SURGIFOAM Absorbable Gelatin Sponge, U.S.P.

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·Raindrop Near Vision Inlay

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·LADAR VISION TREATMENTS

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval
FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval
FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval
FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval
FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System