Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF ASPHERIC UV ABSORBING TORIC INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF & ACRYSOF RESTOR INTRAOCULAR LENSES

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof™ IQ Vivity™ Extended Vision, Toric Extended Vision, Extended Vision UV Absorbing, and Toric Extended Vision UV A

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella Ventricular Support System

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella CP with SmartAssist

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATOR

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF INTRAOCULAR LENSES

P2psa

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH P2PSA ON TH ACCESS IMMNUNOASSAY SYSTEM

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 5.0/LD

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof® IQ Aspheric IOL with the UltraSert Pre-Loaded Delivery System

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Lutonix 018 Drug Coated Balloon PTA Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof™ IQ Vivity™ Extended Vision Intraocular Lens (IOL)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·LUTONIX DRUG COATED BALLOON (DCB)

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5 & Impella CP Systems

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF MULTI-PIECE POSTERIOR CHAMBER (IOL)

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, Impella 5.5 with SmartAssist

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·IMPELLA CP Systems