Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF IQ 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 HBEAG REAGENT PACK & CALIBRATOR

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella Left 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

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

FDA Pre-Market Approval

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

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-HBS REAGENT/ANTI-HBS CALIBRATORS

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, and Impella LD Systems

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

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Pro

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Automated Impella Controller

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 ANTI-HBS

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

FDA Pre-Market Approval

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

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

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

Fluid, Hysteroscopy

FDA Pre-Market Approval

FDA Class 3 ·DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM

Controller, Closed-Loop, Blood-Pressure

FDA Pre-Market Approval

FDA Class 3 ·TITRATOR{TM} MODEL 10K

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Automated Impella Controller

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·LUTONIX 035 DRUG COATED BALLOON PTA CATHETER

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof Posterior Chamber Intraocular Lens (IOL)