Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·LUTONIX DRUG COATED BALLOON PTA CATETER

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

Intraocular Lens

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND 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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOCURVE SOFT CONTACT LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF (R) POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Lutonix Drug Coated Balloon PTA Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit

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

FDA Pre-Market Approval

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

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

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/LD and Impella 5.5 with SmartAssist

Fluid, Hysteroscopy

FDA Pre-Market Approval

FDA Class 3 ·DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·LUTONIX DRUG COATED BALLOON

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATORS

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 PACK & CALIBRATORS

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·IMPELLA

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof Posterior Chamber Single Piece Intraocular Lens

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, and Impella 5.5 with SmartAssist