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

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

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 and Calibrator

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella Ventricular Support Systems

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

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre 14 day Flash Glucose Monitoring System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof Posterior Chamber Single Piece Intraocular Lenses

P2psa

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF MONOFOCAL POSTERIOR INTRAOCULAR LENSES

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

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

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF TORIC SINGLE-PIECE NATURAL INTRAOCULAR LENS (IOL) MODELS SN60T3, SN60T4 AND SN60T5

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator

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 AND CALIBRATOR

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENSES

P2psa

FDA Pre-Market Approval

FDA Class 3 ·Access Hybritech p2PSA Reagents on the Access Immunoassay Systems

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 & CALIBRATORS

P2psa

FDA Pre-Market Approval

FDA Class 3 ·Access Hybritech p2PSA Reagents on the Access Immunoassay Systems

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof Posterior Chamber Intraocular Lens and Delivery Systems

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof Posterior Chamber Single Piece Intraocular Lenses

P2psa

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF IQ TORIC INTRAOCULAR LENSES