Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Lutonix Drug Coated Balloon

Catheter, Balloon For Retinal Reattachment

FDA Pre-Market Approval

FDA Class 3 ·GRIESHABER SCLERAL BUCKLING BALLOON CATHETER

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 / VITROS Immunodiagnostic Products HBeAg Calibrator

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

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

P2psa

FDA Pre-Market Approval

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

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, HBSAG CONFIRMATORY ASSAY

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 5.0

Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

FDA Pre-Market Approval

FDA Class 3 ·FEMSOFT URETHRAL INSERT

Pump, Drug Administration, Closed Loop

FDA Pre-Market Approval

FDA Class 3 ·GENESA(R) SYSTEM

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Lutonix 035 Drug Coated Balloon PTA Catheter

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

Controller, Closed-Loop, Blood-Pressure

FDA Pre-Market Approval

FDA Class 3 ·TITRATOR MODEL 10K

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSERT C DELIVERY SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF IQ TORIC IOLS

P2psa

FDA Pre-Market Approval

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

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-HBC REAGENT PACK AND CALIBRATOR

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·IMPELLA CP SYSTEM

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·LUTONIX 035 DRUG COATED BALLOON PTA CATHETER