252 results · 17ms · Sources: EU EUDAMED, US FDA

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval
FDA Class 3 ·CRYSTALENS ACCOMMODATING INTRAOCULAR LENS AND TRULIGN TORIC INTRAOCULAR LENS

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval
FDA Class 3 ·TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval
FDA Class 3 ·CRYSTALENS AND TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS

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

FDA Pre-Market Approval
FDA Class 3 ·Alinity i HBsAg Qualitative II Reagent Kit (2x l 00 Tests), Alinity i HBsAg Qualitative II Reagent Kit (2x600 Tests), Al

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

FDA Pre-Market Approval
FDA Class 3 ·Alinity i Anti-HBc IgM Reagent Kit (2xl00 Tests)

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·UROLOGIX TARGIS SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·Alinity i Anti-HBs Reagent Kit (2x 100 Tests), Alinity i Anti-HBs Reagent Kit (2x600 Tests), Alinity i Anti-HBs Reagent

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

FDA Pre-Market Approval
FDA Class 3 ·Alinity i Anti-HBc Reagent Kit (2x 100 Tests), Alinity i Anti-HBc Reagent Kit (2x600 Tests)

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·MEDSTREAM PROGRAMMABLE INFUSION PUMP

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoablation Catheters

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM G5 MOBILE CONTIUOUS GLUCOSE MONITORING SYSTEM

HOME BLOOD PRESSURE KIT, ANEROID

FDA 510(k)
FDA Class 3 ·Cardiovascular