Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM

Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM

Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System

Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2 PLUS, HBsAg Confirmatory Test Assays

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2 PLUS and HBsAg Confirmatory Test Assays

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

FDA Pre-Market Approval

FDA Class 3 ·ETI MAK-2 PLUS and HBsAg Confirmatory Test assays

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2 PLUS and HBsAg Confirmatory Test Assays

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

FDA Pre-Market Approval

FDA Class 3 ·ETI MAK-2 PLUS and HBsAg Confirmatory Test assays

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2 PLUS and HBsAg Confirmatory Test assay

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

FDA Pre-Market Approval

FDA Class 3 ·ETI MAK-2 PLUS Assay and HBsAg Confirmatory Test

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2 PLUS and HBsAg Confirmatory Test assays

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2 PLUS ASSAY AND HBsAg CONFIRMATORY TEST ASSAYS

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval

FDA Class 3 ·Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·BIOENTERICS LAP-BAND

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·ORBERA Intragastric Balloon

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Ethicon Endo-Surgery Curved Adjustable Gastric Band with Sutureless Port and Applier; Ethicon Endo-Surgery Gastric Band

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·ORBERA® Intragastric Balloon (IGB) System

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Orbera® Intragastric Balloon (IGB) System