Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (ETAFILCON A) CONTACT LENSES, CLEAR & VISIBILITY TINTED WITH UV BLOCKER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI COOLED ABLATION SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TREO® Abdominal Stent-Graft System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (etafilcon A) Brand Contact Lenses

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (etafilcon A) Brand Contact Lenses

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (ETAFILCON A) BRAND CONTACT LENSES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI COOLED ABLATION SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TREO Abdominal Stent-Graft System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (ETAFILCON A) BRAND CONTACT LENSES

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TREO Abdominal Stent-Graft System

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCT HBSAG REAGENT PACK & CALIBRATOR & VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIRMATORY KI

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DANKER SILICONE LENS (DIMEFOCON-A)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartStart FRx Defibrillator

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·DANKER SILICONE LENS (DIMEFOCON-A)

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·Mammomat Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartStart FRx Defibrillator

Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·M5071A HS1 Adult SMART Pads Cartridge, M5072A HS1 Infant/Child SMART Pads Cartridge

Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·HeartStart OnSite Defibrillator, HeartStart Home Defibrillator, HeartStart HS1 SMART Pads, Adult, HeartStart HS1 SMART P

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION