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 ·LINOX(SMART) S & LINOX(SMART) T STEROID-ELUTING DUAL-COIL ICD LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LINOX(SMART) S & LINOX(SMART) T STEROID-ELUTING DUAL-COIL ICD LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REL S, REL, REL SEZ, REL EZ DUAL COIL, REL SG, REL G, SEN

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO SECURE S SINGLE COIL IS-1/DF-1, ACTIVE FIX LEAD MODEL 6935

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·VITREON INTRAOCULAR FLUID (PERFLUOROPERHYDROPHENANTHRENE)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT/SPRINT QUATTRO/SPRINT QUATTRO SECURE LEAD/TRANSVENE SVC/DF-1 LEADS/SPRINT QUATTRO SINGLE COIL/END CAP ACCESSORY

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LEAD/Y ADAPTORS/IS-1 PORT PIN PLUG/SPRINT LEAD/QUATTRO/QUATTRO SECURE/QUATTRO SINGLE COIL/TRANSVENE SVC/DF-1/Y ADAPTOR

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATH TEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PHUR-CA)

Intracranial Coil-Assist Stent

FDA classification

FDA Class 3 ·Intracranial Coil-Assist Stent

Material, Embolization, Neurovascular, Polymerizing Or Precipitating

FDA classification

FDA Class 3 ·Material, Embolization, Neurovascular, Polymerizing Or Precipitating

Lens, Iris Reconstruction

FDA classification

FDA Class 3 ·Lens, Iris Reconstruction

ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG)

FDA 510(k)

FDA Class 3 ·Cardiovascular

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·PerClot Polysaccharide Hemostatic System

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE (LN 6L22)

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT REALTIME HBV

System, Laser, Fiber Optic, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·Optiguide Cylindrical Fiber Optic