Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 5.5 with SmartAssist

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF INTRAOCULAR LENS (IOL)

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 Intraocular Lens

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 5.5 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-HBS REAGENT PACK/CALIBRATORS

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNADIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATO

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·IMPELLA 2.5 SYSTEM

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 5.5 with SmartAssist, and Impella LD

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

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF IQ SINGLE-PIECE IOL WITH THE ACRYSERT C DELIVERY SYSTME

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CALIBRATOR

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-HBC IGM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF INTRAOCULAR LENSES

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 5.5 with SmartAssist

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella Ventricular Support 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 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-HBS REAGENT PACK & CALIBRATOR

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 & CALIBRATOR